10 Leading Diagnostic Solution Providers 2019

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Vol. 5 / Issue-1
www.insightscare.com May 2019
10 Leading Diagnostic Solution Providers 2019
Robert Hu?stodt President CEO
Empowering Providers through Point-of-care Testing
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Editor-in-Chief Pooja M. Bansal Senior Editor
Anish Miller Managing Editor Ashwini S.
Deshpande Executive Editor Aishwarya
Nawandhar Contributing Editors Sayali Rane, Sneha
Sinha Visualiser David King Art Design Head
Amol Kamble Art Design Assistant Poonam
Mahajan Co-designer Paul Belin Art Picture
Editor Rahul Kavanekar Business Development
Manager Peter Collins Marketing Manager Marry
D'Souza Business Development Executive Mark
Williams Sales Executives Amy, John, Bill,
Sarah Technical Head Jacob Smile Assistant
Technical Head Pratiksha Patil Technical
Consultants David, Robert Digital Marketing
Manager Alina Sege Assistant Digital Marketing
Manager Prashant Chevale SME-SMO Executives
Manoj, Gemson, Uma Research Analyst Eric
Smith Circulation Manager Tanaji
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Dreaching the real problem is very di?cult and
guesswork
Editors Column
iagnosis is a very crucial part of the treatment
of any
health related disorder. Without proper diagnosis,
based treatment methodology in the medical ?eld
can sometimes
be very dangerous. The ?eld of diagnostics is
advancing and many new techniques have come up
that are taking us towards precision medicine
and patient personalized solutions. The
technique that has grabbed a lot of attention in
the last few years is molecular diagnostics. In
simple terms, it means the analyzing of a
patient is done at molecular level. Molecular
diagnostics involve examination of the
biological markers in a persons genome (genetic
code), testing of DNA/RNA sequences for
identi?cation of the disease, cellular testing,
etc. It allows the detection of pathogens in a
human body as well as genetic testing. In
pathogen detection, molecular diagnosis searched
for signs of pathogen-derived nucleic acids in
the patients and hence, helps identify the
infection. In genetic testing, mutation of the
cells, genetic disorders, chronic diseases, etc.
can be diagnosed. Molecular diagnostics can
truly revolutionize care by helping us move
towards accuracy and personalized
medicine. Molecular diagnostics ?eld has seen
rapid and large growth in the past few years and
it is predicted that it will continue to do so
further. This owes to the advantages it brings,
which include accurate, analytically sensitive,
and fast detection as well as monitoring of a
number of diseases. Today, there are various
tools and technologies available for this and it
doesnt stop here, there is so much more to
explore. Molecular diagnostics has not just
enabled disease characterization, but it goes a
step ahead and has enabled patient
characterization. Used particularly in the ?elds
of oncology, infectious diseases, and congenital
abnormalities, clinical pathology at the
molecular level is improving patient monitoring
and management. In 2017, the global market for
molecular diagnostics was reported to be valued
at 7.5 billion and this is expected to go up to
15.6 billion by 2024. With new infection and
chronic diseases coming up every day, it has
emerged to a very important revolution in
healthcare. Molecular diagnostics has the
potential to aid early detection and diagnosis
of diseases as deadly as cancer and the further
advancements in this ?eld comes with a promise of
a better tomorrow!
Future of Medical Diagnosis - Going Molecular!
Aishwarya Nawandhar
Editor
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The Industry Leaders Transforming the
Diagnostic Space
T
he ?rst step to treating any health condition is
diagnosis. If not diagnosed rightly, a patient
may not
receive the needed e?ective treatment on time and
this can lead to major complications in the
future. The signi?cance of correct diagnosis is
taught to every medical student from the very
start.
Today, healthcare is moving towards personalized
medicines and correct detection of the ailment is
the
key to reach there. Although it is very important
to focus on this segment of the care industry,
only two to three percent of the total
healthcare resources are spent on diagnosis,
according to a quali?ed report. There are few
prominent companies that are remarkably
transforming the diagnostics industry with their
innovative tools, technologies, and techniques
and taking us closer to personalized healthcare.
In our special issue of 10 Leading Diagnostic
Solution Providers 2019, we have featured top
diagnostic companies that have not only enabled
correct detection of diseases but have aided in
early diagnosis and are contributing largely to
the better tomorrow of healthcare. Featured on
the cover of this issue is PTS Diagnostics. It is
revolutionizing the diagnostic industry by
innovating point-of-care with people, technology,
and service. Other than the insightful cover
story, we have also featured the top industry
leaders dedicated to provide enhanced diagnostic
care to all. These include BioDirection, a
medical device company that develops
state-of-the-art point-of-care products to manage
traumatic brain injuries and concussions Biolumo
that is focused on developing a set of tools for
fast and inexpensive antibiotic resistance
detection Colorimetrix, which develops testing
applications that turn smartphones into portable
labs, enabling the semi- quantitative
measurement of diagnostic tests at home Genomic
Expression, a leading organization that
sequences RNA to identify the best drug for the
patient and the best patient for the drug
MedCloud, a patient-centered platform for
diagnosis, focused on simplifying test management
in all its phases Exagen Diagnostics GeneNews
IR2Dx and NHG Diagnostics. Apart from this, the
issue also incorporates an ingenious article from
Tania Martin-Mercado, the Chief Technology O?cer
of YGEIA, as well as a few interesting articles
from our in-house editors. So, walk through the
pages and enjoy a good read!
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NTEN
CO
Cover Story
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PTS Diagnostics Empowering Providers through
Point-of-care Testing Adroit Outlook What
Digital Startups Need to Succeed in the
Healthcare Space? 28
9
TS
ARTICLES
Industry Trends Recent Advancements in
Diagnostic Industry
Editors Angle Never Miss a Dose Medication Apps
22
40
BioDirection Unlocking the Power of
Nanotechnology to Address TBI
16
Biolumo Delivering a Fast Point-of-care
Antibiotics Selection Tool
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26
Colorimetrix Bringing Lab Diagnostic Tools to
the Hands of Everyone
Genomic Expression Improving Care and Saving
Lives
32
36
Medcloud Centralizing Data for Decentralizing
Care
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COVER STORY
Robert Huffstodt President CEO
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PTS

• Diagnostics
• Empowering Providers through Point-of-care
  Testing

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T

strategies, and partnerships aimed at helping
healthcare providers thrive in a rapidly
changing industry. Humble Roots Headquartered
in Indianapolis, Indiana, with major operation
he healthcare industry is in a period of
transition both
The industry is in a
domestically and globally. This
period of transition, both
is driven by a host of factors from
domestically and worldwide. We are transforming
along with the industry
legislation and regulation to the growth of
populations with chronic health conditions such
as diabetes. The search for adaptive solutions
is intense, and the pressure on companies and
organizations to innovate and bring new,
high-quality solutions to market quickly is
strong. One of the key challenges for
healthcare solutions providers, is to develop
products and programs that help address the
growing demand for chronic disease management in
a way that increases e?ciency, lowers costs,
and increases patient satisfaction. PTS
Diagnostics, a provider of state-of-the- art
point-of-care testing solutions is rising to the
challenge. Through the companys commitment to
customer focus, innovative technology, and
adherence to robust quality standards, they have
established themselves as a leader in the
manufacture of fast, accurate, and portable
point-of-care testing devices. And, they have
recently begun building more on that strong
foundation with PreVantageTM, a suite of
products,

centers in Sunnyvale, California, PTS Diagnostics
was founded in 1992 by an individual who had
been a?ected by diabetes. As a patient, he saw
how small, portable glucose meters could quickly
and conveniently measure blood glucose levels.
He soon realized that there was an unmet market
need for a similar device that could that could
measure a number of additional chronic disease
risk indicators, such as blood cholesterol and
ketone levels. In its early days, PTS
Diagnostics was a one-man shop, run out of the
founders home. Within a couple of years, enough
angel funding was raised to move to a business
building and hire additional people. In 1997,
the company moved to its current location,
where more o?ce and lab space was gradually
added over the next 25 years as the company
grew. In 2013, PTS Diagnostics acquired A1CNow
from Bayer. In 2016, it was acquired by its
current parent company, Sinocare. The company
has now expanded to such an extent that it has
outgrown its current location, and will move
into a brand new, 145,000 square-foot facility
in the Spring of 2019. Over the years, the
company placed a great deal of focus on growth
and pro?tability, while
holding on to its identity and its reputation
for quality service. It fought against all odds
to ?nd its place in the market, and managed to
get where it is now through perseverance and
angel investments. Im immensely proud of
this, asserts CEO Robert Hu?stodt. Passionate
Leadership PTS Diagnostics is led by President
and CEO Robert Hu?stodt, he is a Notre Dame
graduate with a background in ?nance. He
considers himself very lucky to have had the
opportunity to lead a number of organizations
early in his career. Being assigned the task of
conducting ?nancial audits for startups and
smaller companies helped him gain a thorough
understanding of what made these organizations
tick. When I moved out of public accounting
and into the private world, I again found myself
at a startup. It was here where a mentor gave me
the opportunity to dip my toe into every
discipline, from sales calls to factory
management, he says. This gave him a ?avor of
what it was like to run a whole business from
top to bottom and has directly contributed to
his success with PTS Diagnostics. Hu?stodt has
also always had an a?nity for international
business. This has served him well as the
receptivity
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to PTS Diagnostics products in dozens of
markets around the world has continued to
grow. On the personal side, Hu?stodt has a
passion for music, art, and architecture. These
interests have inspired him to create an
environment within the companys new global
headquarters that is conducive to creativity and
innovation. People, Technology, and Service
The companys name represents the three pillars
upon which it has built its long-term success
People, Technology, and Service. People starts
in-house with the skills, talents, and energy of
PTS Diagnostics global employees and partners.
It extends to its strongly-held value of
providing high-quality service, person to
person. Thats why the company intends to always
have real humans answering its calls. It sends
the signal that were approachable and are about
people, says Hu?stodt. Technology points to
the companys innovative products and solutions.
PTS Diagnostics integrates old technology and
new technology to develop products that are
accurate, reliable, and easy to use. Hu?stodt
says, Were not trying to release new updates
just because we can. Pairing well-tested
elements with modern updates that we believe in
allows us to have the best of both worlds.
Since PTS Diagnostics has been focused on
perfecting its craft instead of always rushing
to the newest thing, many of its technologies
and products have stood the test of
time. Service also has a dual meaning.
Internally, the company prizes excellent service
provided among departments and employees, but it
takes particular pride in the level it service
it strives to provide to the customer, which
ranges from training
to logistics and other elements of its business.
As the company moves beyond its products, and
toward more comprehensive services and solutions
with PreVantage, service will take on yet
another level of signi?cance. Flagship
Products PTS Diagnostics signature products
include the CardioChek analyzer and the A1CNow
test system . Both products stand out in the
market by being incredibly portable, e?cient,
and accurate. They also recently launched
PreVantage which aims to enhance those products
with added convenience, connectivity, and
extended service features. With PreVantage,
CardioChek and A1CNow are not mere devicesthey
are part of a solutions package that links to
Electronic Medical Record (EMR) systems, which
are the backbone of many of todays healthcare
organizations. The bundled PreVantage product
and connectivity o?erings are intended to help
healthcare organizations transition from Fee for
Service payment models to Value-Based Payment
models. Other products The company also o?ers
the PTS DetectTM cotinine system, PTS CollectTM
capillary tubes, and PTS ConnectTM solutions.
technology and innovation to blood collection.
And, PTSConnect ProLink and PTSConnect ScreenPro
simplify point-of-care health data collection
and transfer for health and wellness companies,
retail clinics, and urgent care centers. What
Sets PTS Diagnostics Apart The creative business
approaches and the collaborative spirit behind
PTS Diagnostics are what allows it to work with
partners all over the world and continue to grow
year after year. The company is also unusual in
that it has succeeded largely on its own,
without venture capital or a large benefactor.
It has bootstrapped itself on angel money,
survived, and thrived. The history and background
of the company has placed it in a unique
position to serve new healthcare delivery and
payment systems. PTS Diagnostics envisions
becoming a
PTS Detect cotinine is the ?rst and only
quantitative tobacco-detection system that can
measure exact cotinine levels from a simple
?ngerstick. PTS Collect capillary tubes brought
new new
The growth of our
organization will come from organic growth in
our markets, expansion of product offerings,
broader menus, and more

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We strive to be innovative in our
business models and practices, as
well as our products, and to create a situation
where everybody wins, from the employees and
internal stakeholders to our business partners,
to end users, patients, and society at large

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We want to achieve consistent
pro?table growth while maintaining our focus on
providing products and services that bene?t the
constituents

global leader in providing innovative,
point-of-care products and services that aid
healthcare providers in their preventative
healthcare and chronic disease management
e?orts. Other factors that set PTS Diagnostics
apart from its competitors are its size, its
promptness, and its resourcefulness. As a
company, PTS is the right size to provide
customers with ?exibility and personalized
service. Were not so big as to be rigid,
ponderous, and slow to react, on the other hand,
were not so small as to have too limited of
resources Hu?stodt says. Service and going the
extra mile make us stand out. An Insight into
Product Training PTS has a multitude of tools
that enhance its training process for both
professional and home users We have a range of
options available and we dont pigeonhole
customers into methods that are unconducive to
their learning style or schedule, says
Hu?stodt. He continues, For us as a company,
the realization of how important that was a
watershed moment. Notable Awards
Accreditations In addition to its numerous
product accreditations, PTS Diagnostics has
earned recognition for its unique product
o?erings and continued success. In addition to
being listed as one of Inc. Magazines 5,000
Fastest Growing Companies six times, the company
has also been featured on the Today Show, Doctor
Oz, and other similar programs abroad.
Disrupting the Point-of-Care Solution
Industry One of the biggest disruptions to the
healthcare industry in recent years has been the
shift in reimbursement models in the United
States, speci?cally the moving away from fee-
for-service models toward value-based models that
pay based on the e?ciency and e?ectiveness of
care. PTS Diagnostics has recognized that
outcomes are the new income and has the right
products mix of product o?erings and industry
partners to help healthcare organizations make a
positive impact on value-based payment
objectives. The portability and ease-of-use of
PTS Diagnostics products also position them
well to help retail pharmacies, urgent care
centers, and community health centers o?er lipid
panel and A1C wellness testing in a way that
often more convenient for patients. Future of
PTS Diagnostics The company is currently in a
period of multiple simultaneous transitions. The
?rst is the building of a new headquarters which
will be completed in the second quarter of 2019.
The launch of PreVantage solutions is also
underway and is continuing to grow and evolve as
a product o?ering and business model. And, new
technological innovations are also in the
pipeline. We certainly believe that well see
double digit growth for the foreseeable future,
asserts Hu?stodt.
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Relentless innovation
for improving the diagnosis and management of
TBI is what drives us. We are dedicated to
improving treatment plans and saving more and
more lives -Sharad Joshi President CEO

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BioDirection
Unlocking the Power of
Nanotechnology to Address TBI
Tto take care of up to 10 Billion Traumatic
Brain Injuries (TBI). CDC estimates the
raumatic Brain Injuries (TBI) and sports related
concussions have become very common
and are increasing at an alarming rate. There is
an enormous unmet global market need
direct or indirect cost spent on treatment of
these concussions to be greater than 76 Billion
in the US alone. Over 75 percent of TBI are
classi?ed as mild traumatic brain injuries while
90 percent of the people with concussions never
lose consciousness. There is a lack of an
objective point-of-injury (POI) or point-of-care
(POC) test. TBI testing today is symptomatic
diagnosis,
which has a high error rate and is not at all
de?nitive. This is where BioDirection, Inc. steps
in and has the potential to manage the diagnosis
in a speci?c and timely fashion. BioDirection is
a privately held medical device company
developing cutting-edge and rapid point-of-care
or point-of-injury products for the objective
diagnosis and management of concussion and other
traumatic brain injury (TBI). It is leveraging
the power of nanotechnology to address the rapid
and de?nitive diagnosis of TBI. BioDirection
Tbit System The companys ?rst product Tbit
System is a whole blood POC or POI test platform
for traumatic brain injury. It is rapid and
a?ordable test that generates a result in less
than two minutes from a single drop of blood.
The system measures targeted brain biomarkers
released from the brain following a head trauma
or jolt to the body. The platform is
easy-to-use, portable and low-cost system
(a?ordable), it consists of two components
tabletop or handheld analyzer and a single-use,
disposable sensor cartridge. The disposable
sensor drives signi?cant revenue razor blade
annuity. Tbit System has the potential to
generate a high margin business with strong cash
?ow. BioDirection has exclusive, global rights
to a Harvard generated patent portfolio for
acquired brain injury and Sepsis plus extensive
nano-wire based biosensor design or manufacturing
know-how. The system is based on design of
nanowire biosensor produced from nanowires. A
single nanowire is 1/10,000 of a human hair.
Tbit System o?ers ultra-sensitivity and
speci?city. / MAY 2019 / 17
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pre-revenue start-ups, mid-market companies to
large scale companies, such as Proctor Gamble.
He also has the expertise in creative product
development, marketing, and technical sales
instrumentation and capital equipment. Serving
Global Diverse Market BioDirection estimates up
to a 5-Billion-dollar market in USA alone for
its products with potential to treat greater 50
Million people around the globe. TBI injury
impacts all walks of life and age groups with
high potential targets extending well beyond
sports (all levels youth, interscholastic,
university/college, and professional).
Additional targeted markets include military
training and deployment, hazardous work
environments, senior living or nursing
facilities, medical clinics and physician o?ces,
?rst responders and ambulances, rural medicine,
educational facilities, recreation and disaster
relief. BioDirections ?rst targeted market is a
screen to a CT scan, which it estimates is up to
5 million CT scans for head injury per year in
the USA. The company is awaiting its ?nal trial
results, which the company believes will
approach 100 percent sensitivity to positive CT
scans (100 NPV) and ability to detect abnormal
protein levels consistent with micro-bleeding
not found in negative CT scans. It has already
received FDA Breakthrough Device Designation in
January 2019. Subject to FDA review and
clearance, BioDirections ?rst target is to
launch Q1 in 2020 this is subject to FDA review
and clearance process. Future Road Map
Development Strategies Moving beyond the screen
to CT, BioDirection plans to modify the existing
TBI System providing the full continuum of care
for TBI patients including strati?cation of
injury, prognosis, and post-operative return to
activity or play. Additionally, the company is
also seeking a partner to develop rapid testing
products for sepsis, which also require rapid
diagnosis in critical conditions.
It uses the selected GFAP and S100b as initial
targeted biomarkers these are clinically
validated over 50-60 years as acute biomarkers
for TBI. S100b is approved as a screen to CT in
over 20 countries world-wide outside of USA.
Tbit System is a ?exible and versatile platform
and is not biomarker dependent and readily
adaptable to new biomarkers. It has full
multiplexing functionality, capable of measuring
2, 3, 5, 10 or more biomarkers simultaneously.
It is a game changing technology and the company
is targeting market entry late Q1 2020. The
Outstanding Leadership Sharad Joshi, the
President and CEO at BioDirection is a dynamic
leader who fosters a mission-centric, fun, and
collaborative environment. He holds B.Sc
(Mechanical Engineering) degree with a Pre-Med
minor from Northeastern University and graduated
cum laude with an MBA from Babson College in
Wellesley, MA. He has over three decades of
experience in the medical device ?eld including
management positions as CEO, President, COO,
Marketing, International Sales, Engineering,
among other executive positions. He has also
been the inventor and author of numerous patents
and publications. Sharad has also served as a
business advisor or technical consultant at
various companies including
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Jakub Wysocki CMO
Olga Grudniak
Wojciech Gizowski
VP COO
CEO
Biolumo
Delivering a Fast Point-of-care
Antibiotics Selection Tool
Amonetary resources as well as a lot of companies
ntibiotic resistance is a major problem faced by
the
success alone, believes Biolumo. It believes in
working as a team and with partners. The roles
in the company re?ect the responsibilities and
skillset, not hierarchy. Biolumo has an amazing
team starting with its Chief Science O?cer,
Marcin Pitek, who came with the idea. Olga
Grudniak is the CEO, who combines science and
business together. She is very recognized, young
businesswoman. Wojciech Gizowski, the COO, is an
expert on building both relations and products.
He is responsible for the most partnerships and
mentors that keep the company going. Jakub
Wysocki keeps Biolumo on the lips of both media
and investors. All of them have played important
roles in the companys success. The Journey of
Biolumo Post Biolumos inception, the ?rst months
were devoted to testing its initial idea to
identify antibiotics resistance in the patients
samples. Since then, Biolumo has evolved this
method and designed fully automated prototype
that can be used by every nurse.
healthcare industry today. It has cost a lot of
have invested their time in ?nding a solution to
this.
Biolumo, an innovative and growing company based
in Gdynia, Poland, was also set on the same
quest. It faced a question from its mentor and
business advisor, Can you point any solution
that will make me sure my son got the right
antibiotics prescribed? This question lighted a
spark in the companys team a spark that
started the ?re called Biolumo. Today, the
company is focused on developing a set of tools
for fast and inexpensive antibiotic resistance
detection. Founded in 2017, Biolumo has its
major operation centers in Pomerania Science and
Technology Park, Gdynia. It o?ers a diagnostic
e?ectiveness on antibiogram level, delivering
results 8 times faster. The Fuel to its
Success No one person can achieve true science
and business
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23
It has participated in one of the best
acceleration program in the world
Startupbootcamp Digital Health, which helped
Biolumo in planning its international growth
strategy. In Poland, the companys country of
origin, it has managed to partner up with the
biggest healthcare companies on the market.
Our mission, even before the Biolumo conception,
was to ?ght antibiotics resistance the best we
can, says Olga. The want to give scientists
time to develop a sustainable successor for
traditional antibiotics was the goal of
Biolumos science team, this also included
boosting e?ectiveness of diagnostics amongst the
group that prescribes the most antibiotics,
General Practitioners. Unique Point-of-care
Solution Biolumos ?agship product is a fast,
point-of-care antibiotics selection device for
general practitioners and clinics. The company
is o?ering diagnostic e?ectiveness on
antibiogram level, by delivering results eight
times faster. Furthermore, its solution is
automated and therefore, easy to use. It can
also provide a new revenue stream for
clinics. This product is a brilliant combination
of biotechnology, hardware, and software. The
company has used modern technology instead of XX
century method, which allowed it to identify
antibiotics resistance much faster. With
Biolumos ingenious product, a laboratory,
trained specialists, or the transporting sample
are not needed to reach the results and that
minimizes the costs further.
The companys interdisciplinary approach and its
focus on ?nding the best combination of these
disciplines is the key factor leading it towards
success. Honorary Laurels For its remarkable
contribution, Biolumo has been recognized by
many national and international organizations
highly regarded amongst the healthcare society.
One of the biggest distinctions Biolumo has been
honoured with was being listed at prestigious
Global Digital Health 100 ranking by The Journal
of mHealth. It has also been awarded the title -
The Healthcare Leader during The XXIII
International Open Healthcare Congress by the
healthcare key opinion leaders in its region, in
January 2018. Biolumo won the 2nd place at
infoShare 2018 Startup Contest, the competition
that takes place during the biggest startup
conference in the CEE region. Furthermore, at
the beginning of 2019, its CEO, Olga Grudniak,
has been named The Best Entrepreneur in 25 Under
25 by Forbes and The Businesswoman of the Year in
Poland. Whats Ahead? Biolumo is working hard
to roll out its device, as soon as possible. We
want to give scientists the time to develop a
sustainable successor for traditional antibiotics
our science team included by boosting
e?ectiveness of diagnostics, says Wojciech.
After that, it has developed plans for the next
features and upgrades in its product. Speaking
about the future endeavors, businesswise,
Wojciech asserts, We are working on strategies
for international lunch of our device. To get
the e?ects we hope to achieve, we need to
provide our solution worldwide, not only in our
region. Simultaneously, the company is
continually working on the next generation
antibiotic that should be a long-term solution
for the problem, which may take some time and
resources as developing any new drug does.

We aim to improve
care for all, by
finding an answer to the antibiotic resistance
problem, with an interdisciplinary approach

/ MAY 2019 / 21
24
Recent Advancements in DIAGNOSTIC INDUSTRY
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25
Talso helps them in identifying the root of a
disease before it becomes serious.
Industry Trends
he healthcare sector is moving from reactive care
to preventive care. Preventive
care helps the patient take necessary precautions
to avoid certain conditions and
Additionally, the cost of preventive care is much
less than that of reactive care.
Diagnostics is a major part of preventive care.
All the conventional treatment methods mostly
follow the trial and error method, where the
illness is guessed based on the symptoms the
patient shows. It is necessary to move ahead from
this method to personalized care to improve the
outcomes of healthcare. Optimum diagnosis is the
?rst step towards this. The diagnostics industry
is witnessing immense transformation and there
are various new developments that are helping it
move towards personalized care. Let's look at
the recent devices transforming diagnostics.
Better Detection of Ebola Virus with a
Micro?uid Device
Ebola is a highly contagious and deadly virus and
once infected, it leaves limited treatment
options for the patient. Moreover, it can spread
easily and start an epidemic. To combat the
dangers it brings to the human lives, scientists
at the Rochester Institute of Technology (RIT)
have developed the prototype of a novel micro
device. This device helps diagnose the infection
caused by Ebola early, which results in better
treatment outcomes as well as reduces the spread
of infections. The developed micro?uid device
has biosensors attached to it. It is a small,
automated chip that has ?uorescence sensors
attached to it. The device detects the Ebola RNA
when the patient's sample is added to it by
activating the CRISPR mechanism. The researchers
are further trying to ?nd a way to generate this
device at affordable costs. / MAY 2019 / 23
26
KidneyIntelX- A Breakthrough Device
KidneyIntelX is the main diagnostic test for
kidney diseases devised by Renalytix AI plc. It
exhibits promise to improve the clinical
management of patients with fast-growing kidney
diseases and type-2 diabetes. It helps in better
diagnosis and well as treatment of these.
KidneyIntelX uses machine learning algorithms to
examine the combination of predictive blood-
based biomarkers. These include sTNFR1, sTNFR2,
and KIM1 along with the electronic health record
data. The device is designed to identify the
progressive kidney disease. It was designated as
a Breakthrough Device by FDA.
Q-POC A Revolutionary Diagnostics Kit
KidneyIntelX is the main diagnostic test for
kidney diseases devised by Renalytix AI plc. It
exhibits promise to improve the clinical
management of patients with fast-growing kidney
diseases and type-2 diabetes. It helps in better
diagnosis and well as treatment of these.
KidneyIntelX uses machine learning algorithms to
examine the combination of predictive blood-
based biomarkers. These include sTNFR1, sTNFR2,
and KIM1 along with the electronic health record
data. The device is designed to identify the
progressive kidney disease. It was designated as
a Breakthrough Device by FDA.
24 / MAY 2019 /
27
A Remarkable DNA Sequencing Device- MinION
MinION, a new DNA sequencing device by Oxford
Nanopore, can detect the Huntington's disease a
lot faster than the traditional ways. It could
therefore drastically reduce the waiting time
for number of critical cases of Huntington's
disease, as well as other genetic disorders in
the future. Moreover, it meets the strict
international quality standards for laboratory
use.
MinION is a small device which decodes every DNA
strand separately in real-time. This hand- held
device can then identify the changes in any DNA
sequence to detect the genetic disorder. Being
able to do all of this in real-time, the device
cuts down the wait time for the results.
Mass Spec- Promise of a Better Tomorrow
MinION, a new DNA sequencing device by Oxford
Nanopore, can detect the Huntington's disease a
lot faster than the traditional ways. It could
therefore drastically reduce the waiting time
for number of critical cases of Huntington's
disease, as well as other genetic disorders in
the future. Moreover, it meets the strict
international quality standards for laboratory
use.
MinION is a small device which decodes every DNA
strand separately in real-time. This hand- held
device can then identify the changes in any DNA
sequence to detect the genetic disorder. Being
able to do all of this in real-time, the device
cuts down the wait time for the results. The
medical diagnostics industry is advancing at a
fast-paced. The new innovations come with a
promise to enhance the accuracy of detecting
diseases in a human body in real-time. Moreover,
the ease of use, simplicity in manufacturing as
well as the affordability of the latest devices
is improved. -Aishwarya Nawandhar, Editor / MAY
2019 / 25
28
Colorimetrix
Bringing Lab Diagnostic Tools to the Hands of
Everyone
Our mission is
to help consumers with direct access to
healthcare tools they can use at home
Dominik Westner CTO Dr. Leo Martinez
CEO riven with the passion of Making diagnostic
lab tools accessible to everyone, Colorimetrix
was

D
of Innovators under 35 by the MIT Technology
Review in 2014 for the technology. Mr. Westner,
on the other hand, is a seasoned software
entrepreneur, with a successful exit to
Blackberry in 2011. They both are spearheading
Colorimetrix with their inimitable talent and
have achieved milestones together to bring
Pearl Fertility to the market
(www.pearl-fertility.com). The Story of
Colorimetrix Colorimetrix started as a small
project, as the lab in pocket or pocket
diagnostics. While Dr. Martinez was working in
the lab, he broke a spectrophotometer machine,
which is a very expensive and bulky machine,
which made him realize that most of the machines
required in healthcare procedures are heavy,
weight-wise as well as cost-wise. He then started
dreaming of making them obsolete with software
and small hardware and then realized that almost
all they do is already included in a mobile
phone. Since then, Dr. Martinez and his partner
Dominik started working on multiple
established in 2014, and o?cially started
commercial operations in 2017. Colorimetrix
decided to
help women seeking to get pregnant with their
?rst product Pearl Fertility released to the
market in 2018. Since then, its drive has been
the same, to bring knowledge forward, where it
is most needed, in the hands of consumers seeking
information about their bodies in a more
personalized and understanding way. Pearl
Fertility is a self-monitoring kit to test
hormones at home. Women can see their hormones
rise and fall during their cycle and get
personalized information. For couples who are
trying to conceive, this is crucial, as knowing
when the fertile days are based on reliable
accurate predictions, can lead to kick starting
a new, wonderful journey. About the Duo Dr. Leo
Martinez is the CEO and Dominik Westner is
the CTO of Colorimetrix. Dr. Martinez was
included in the list
26 / MAY 2019 /
29
applications of the technology. The number of
potential applications was vast and broad, after
a lengthy process of de?ning the product that is
when ?nally the decision was made to go with
Pearl Fertility- Colorimetrixs ?rstn product,
ovulation and fertility tracking at home, the
?rst fertility test that includes up to three
individual hormones. Awards and
Recognitions Apart from the MIT Innovators under
35 Award, Colorimetrix holds the Seal of
Excellence from the European Commission for top
SME companies. The company has also been a part
of the Mass Challenge Accelerator in
Switzerland and is a Grantee of the EIT- Health
in Europe. Colorimetrix was also a part of the
Google Launch Pad for startups in Germany, and
has gained recognition in various pitching
events in Europe. Testimonials The true success
of any company is measured by the number of its
happy clients. Colorimetrix has been an
essential part of its clients journey and they
speak really highly of the companys ovulation
tests kit, Pearl Fertility We used this
product to con?rm ovulation which we measure
using LH test sticks. This was an easy to use
test- the main catch is to remember that youre
looking for only one line to con?rm
progesterone, rather than the standard two lines
of other positive tests!- Amazon from
Danielle We are very happy to share with you
the joy of having a baby and let you know that
Pearl was of great help in the journey, every
test strip we took was worth the e?ort-
Fernanda, Nutritionist Simplifying Life of
Patients and Physicians Colorimetrix says that it
is easy to misuse the word patient in the
Fertility topic. The truth is that many people are
immediately classi?ed as infertile because of the
lack of consensus and the lack of knowledge in
the fertility space. In reality, there are
several conditions that a?ect fertility, and it
does not necessarily mean they make you
infertile, some are treatable and some may just
lead to one taking longer journeys to conceive,
but not necessarily make one infertile or in
need of IVF right away. The company believes
that patients are often left alone after the
doctors visit and the doctor tells them to keep
trying back at home, but there is no way for the
doctor to be there with them in those moments of
frustration and despair. The medicine of the
future is the one that comes to you, when the
doctor comes to you, when the lab comes to you,
when the hospital comes to you. We are just
providing a small piece of the puzzle in the
future of medicine. That one that is
personalized, predictive, at home delivers
Dr. Martinez. Future Plans Colorimetrix is
planning to bring more interesting tools for
self-monitoring at home to the market. It is also
likely to expand its focus from the fertility
space to other segments of concern. Also, the
company is helping enterprises with solutions
for their daily testing routines outside of the
health space. On asking him about the positive
trends going on in the diagnostic industry, Dr.
Martinez said, Diagnostics at home, that is the
key, that is the trend. Not to mention that it
has to be personalized, perhaps an old trend but
the one so many companies forget to address
still. This is what we are doing. While talking
about the future goals of Colorimetrix, Dr.
Martinez said, The clinic, the lab, the medic,
comes to you, that is the future we are building
up here. Fertility is our ?rst topic, there are
many more to tap into.
/ MAY 2019 / 27
30
Digital
Need to in the Space?
About the Author Tania Martin-Mercado, PhD, is
the Chief Technology Officer of YGEIA, a digital
healthcare company focused on home healthcare
and chronic disease management. She holds
various degrees in IT, healthcare, as well as
biotechnology and is seasoned with a lot of
experience at various prestigious posts
throughout the years. Being a curious soul and
always been fascinated with technology, Tania
has been a part of various healthcare
innovations. 28 / MAY 2019 /
31
Adroit Outlook
Tania Martin-Mercado Chief Technology Ocer
YGEIA
/ MAY 2019 / 29
32
Wtechnology to home monitoring and data, data,
data digital healthcare has morphed into one
e hear a lot of buzz in the industry and in the
marketplace about the latest in digital
healthcare.
From arti?cial intelligence, machine learning,
remote patient monitoring and wearable
of the most transformative healthcare trends.
While this is one of the most exciting times to
be in the digital healthcare market, startups
focused on this space need to make sure their
product and service have three-fold impact
Improved patient outcomes, reduced cost of
delivery, and quality of care. Cost, quality and
patient experience often go unnoticed or ignored
in favor of technical functionality. The latest
and greatest digital healthcare technology will
fail if the patients dont understand how to use
it, providers cant implement it into their
work?ow, and payors wont reimburse for its
use. By starting with a patient-centered focus,
digital startups will ?nd they may need to slow
down and get a better understanding of the
healthcare industry, which operates di?erently
than the tech world. There are more stakeholders
in healthcare that need consideration doctors,
patients, insurers, regulators each of these
stakeholders holds a unique perspective on the
technology being adopted. Healthcare is complex
because patients are complex. As digital startups
focus on one area, such as a particular disease,
they may stumble onto the multiple factors that
contribute to that disease, what insurers do and
dont cover related to that disease and its
symptoms, and more variables that directly or
indirectly a?ect their product or service. The
development of a product or service requires
research into clinical practice, medical study,
patient and doctor interviews, and several focus
groups. Digital healthcare startups need to have
patience something that is unattractive to some
investors, causing digital healthcare startups to
rush into product development too quickly.
Instead, involving key stakeholders early in the
development process and fully understanding the
concerns and perspective will allow these
startups to impact the healthcare space where it
matters most patient care. The Medical
Futurist published a fantastic article earlier
this year that highlights why healthcare startups
fail. Forgetting about the patient, not
including the provider, di?culty creating
clinical value and overclaiming what the
technology can do area just a few of areas
discussed in this article. Another area often
overlooked by digital healthcare startups is the
need to integrate. Healthcare data is massive,
and there is no central repository to draw
from. By understanding and embracing the need for
shared services, integration with other startups
or providers in the healthcare industry can
foster innovation and better meet patient need
or demand. Instead startups may focus on siloed
solutions that make it di?cult for providers to
implement into their practice, thus not o?ering
value to the patient. By understanding how
patient data is viewed from a provider and payor
perspective, digital healthcare startups will
?nd out how their product or service will be most
useful. This is such an exciting time to be in
the healthcare space. The satisfaction of making
a positive impact in communities by improving
patient care is why many startups dive into the
healthcare space. By taking a few of these
points into consideration, digital healthcare
startups will ?nd their endeavors bearing fruit.
30 / MAY 2019 /
33
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34
Genomic Expression
Improving Care and Saving Lives We emphasize
on the patient first and aim to create a
company that respects the individual Gitte
Pedersen CEO Co-founder and embraces diversity

H
Founders Network, XTC (Richard Branson),
Molecular Tri Conference, Red Herring,and MedTech
Innovator. It has also been felicitated with
the Lyfebulb-Helsinn Award, EIC Life Science
Award, and EUTop50, and Gitte has presented
at the European commission as well as at the
United Nations. A Journey that Brought
Innovation Genomic Expression was started with a
large grant from the Danish Government as the
diagnostic partner of Genome Denmark. Gitte
and Morten then leveraged that success to raise
its ?rst round. With just a patent and an idea in
hand at that time, the team travelled over the
valley of death by raising grant money. Today,
the company has 4 fully funded clinical programs
validating its platform - OneRNA, in four
di?erent cancer types with a strong focus on
womens cancer ?rst - all funded by
grants. Genomic Expression could achieve this
level of backing because of its ground breaking
data. We identify marker for a handful of
already approved drugs in 100 of the
eadquartered in Beverly, MA, and founded in
2012, Genomic Expression is a prominent
organization that sequences RNA to identify the
best drug for the patient and the best patient
for the drug.
The company is spearheading with a vision to
revolutionize healthcare by truly
individualizing it, which in oncology means
selection of e?ective treatments that either cure
cancer or at least make it chronic and not a
death sentence.
The company was established by Gitte Pedersen,
the CEO and Co-founder, and her brother Morten
Pedersen, after their mother was diagnosed with
cancer. Gitte and Morten both are scientists and
they knew that the diagnosis was a death
sentence if they followed the standard of care
guidelines. As a result, they searched for a
better drug in clinical development. However, in
order to ?gure out which clinical trial could
potentially bene?t their mother, they needed to
better understand the tumors genetic pro?le. For
that, they looked for a tool that could do the
analysis on a large scale and such a tool did
not exist. This gave them a kick-start to incept
Genomic Expressions. Today, the company has top
placements in Womens
32 / MAY 2019 /
35
patients by sequencing RNA instead of DNA. This
is true in any cancer type. In a world where
only 1 out of 4 cancer treatments actually
prolongs life, we believe we can greatly improve
outcome and reduce recurrence, and that is what
we want to prove in these clinical programs,
asserts Gitte. She further continues saying, We
also believe that treating patients with drugs
that actually work as a ?rst line of treatment
will decrease cost of care, since managing the
side e?ects for some of the more toxic drugs are
expensive, and cost of losing mothers and
fathers is signi?cant cost to the
society. OneRNA A Unique Flagship Product of
the company Genomic Expressions OneRNA
sequencing platform enables a paradigm shift
from ONE disease, ONE marker, ONE drug to ONE
patient, MANY markers, MULTIPLE treatment
options that go beyond drugs by sequencing RNA
and linking data to treatments. OneRNA is
positioned to disrupt the current standard of
care paradigm which only prolongs life for 1 out
of 4 patients in oncology, while we are spending
100 billion on drugs and 8 million patients
die. Using the existing drugs as the toolbox,
the company believes that it can prolong life
for most patients and in contrast to drugs,
clinical approvals can be obtained in less than
12 month. Thus, this paradigm shift is a
breakthrough because itcan select the best drug
for the patients real-time problems. For an
instance, new drugs get approved or enter into
clinical trials all the time and if there is a
match between the tumor and this new drug,
information can be pushed to the patients
doctor. Besides, OneRNA is a platform that
integrates work?ow from RNA extraction in FFPE
samples, proprietary RNA-seq library generation,
using Illumina sequencing and proprietary
algorithms to analyze the data and several
proprietary databases. It enables the
identi?cation of aberrantly expressed genes
through to the clinical interpretation. This
platform is exponentially scalable and can be
moved into other indication with an update to
the clinical database. The development of this
platform has been enabled by Next Generation
Sequencing and AI/Big data analytics. Until now,
the company has raised 6.5M in grants to
validate OneRNA in 4 types of cancers, from the
Danish Innovasion Fund, EuroStars, and
Horizon2020.
Happy Clients at Genomic Expression The true
award for any company is its happy clients.
Genomic Expression has received numerous positive
feedbacks from its satisfactory
clients. Measurement of gene transcription
through quantitative measurement of RNA
sequencing, as made possible by Genomic
Expressions approach, will add signi?cantly to
current methods to characterize the molecular
features of individual cancers and guide
personalized therapy.- Dr Shridar Ganesan,
Rutgers Cancer Center Being able to identify
responders and non-responders to novel
treatments by analyzing blood in combination with
the OneRNA platform has the potential to
further improve care and reduce cost. Being able
to substitute a highly invasive and expensive
biopsy with a blood-based biomarker assay is not
only bene?cial for the patient, but also
potentially able to reduce cost of care.- Dr
Jonathan Hernandez, The NCI Future
Plans Genomic Expression would be launching
OneRNA this year while its mission is to get
the test into standard of care in women cancer
?rst. The company has at least three data
packages that are being published over the next
couple of years. The company is planning to
expand internationally and wishes to address all
cancer indications where there is an unmet need,
through partnerships and also by raising
additional capital. The company can also move
into other indications, such as autoimmune
in?ammatory diseases and all the way to health
monitoring and would be focusing more on
revolutionizing the healthcare system.
/ MAY 2019 / 33
36
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37
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Medcloud
Centralizing Data for Decentralizing Care

Medcloud aims to
Offer the next generation of Cloud services for
Diagnostic Management, by accelerating the
transition of diagnostic centers and hospitals
to the Cloud

Dimas Francisco Silva Jr. CEO
T
echnologies like Cloud and I.A has been
determining the future of almost all the
industries and the diagnostic solution industry
isnt

• through a worldwide imaging center cloud
  platform.
• The Unique Products and Services O?ered
• For imaging centers, Medcloud is a
  patient-centered platform for diagnosis, focused
  on simplifying test management in all its
  phases. Unlike other medical imaging solutions,
  Medcloud o?ers customizable and integrated
  solutions for any kind of medical tests,
  combining in a single application all the
  required tools for diagnostic teams and a mobile
  way to share the test results. Using its patient-
  doctor portal, patients can listen to the voice
  of a radiologist explaining test results in
  simple terms, keeping medical history
  centralized and sharable. The company has
  developed a cloud platform solution for tests and
  medical reports. Some of the features of this
  platform are
• Send or receive tests from any location easily,
  storing them fulltime with automated backup
  routines
• Access tests, anytime, anywhere, through a
  ?exible management and reporting tool
• Share tests with patients and doctors, engaging
  them through a modern patient portal and App

di?erent. The big volume of data, the instant
access of
information and the constant increase of
computation power has enabled a new era for I.A
in Healthcare. One such eminent company that has
integrated these technologies in
its functioning is Medcloud. Cloud and I.A is a
natural move for Medcloud. Headquartered in São
Paulo, Brazil, with its operation center in Rio
de Janeiro, Medcloud was established in the year
2012. PACS and medical systems imaging has been
pretty much the same for the past 25
years. Interoperability issues, high costs, and
a lack of understanding about the role of the
patient in a diagnosis context. These points have
de?ned limits for the patient-doctor
relationship and barriers for radiology
work?ows. Medcloud is committed to revolutionize
that through a care-coordination solution that
improves work?ows for providers and integrates
doctors and patients to a better care. As
diagnosis has been a part of the patient
journey, it is working on empowering millions of
lives
36 / MAY 2019 /
39

• Medcloud respects the privacy of patient data and
  has ways of using clinical, demographic and
  statistical data in the prevention of diseases
  and monitoring of chronic patients. Besides
  that, Medcloud has its own I.A engine in order to
  help radiologist on their daily basis work?ow.
• The Medcloud App
• Medclouds App is aimed to provide patients with
  the best experience in accessing and sharing
  exams as well as to bring them bene?ts with a
  new digital experience, such as Ÿ Accessing all
  exams in real time, anytime, anywhere Ÿ Keeping
  medical history centralized. It can be shared
• with a new doctor when necessary
• Digitally interacting with a specialist in a
  virtual pre- appointment
• Listening to the voice of a diagnostician
  explaining test

The bene?ts of this technology can be found not
only in the optimization of clinical work?ow but
also by providing a secure, reliable and
uncomplicated way patients can access their test
results and share with their doctors. The
business model used by the company is SaaS
having the diagnosis clinics as their main
clients. As the solution is almost plug and
play, the laboratories and diagnosis clinics can
have a very fast tool to enhance service and
provide a closer care of their patients, while
at the same time reducing costs. Were
delighted to see day by day a large number of
healthcare companies experience a more secure and
intelligent way to manage, store and share
clinical data, says the CEO. Furthermore, the
platform can be used as healthcare marketplace
and for that the company is currently working in
two new developments Clinical trials MedCloud
empowers patients to have access to the
information in tests. The system can be
transformed into a platform to gather
information for clinical trials. Patients can
easily decide whether to grant access to the
results of their test in exchange of ?nancial
compensation for the use of this information in
clinical trials. It is a direct channel to
valuable information that can help many
studies. Medical Labor marketplace Diagnosis
clinics and laboratories can use the platform to
hire remote skilled medical labor to work on
tests and diagnosis. Also, thanks to the large
volume of information and approaches of Data
Science and Big Data, Medcloud provides trivial
means of research and scienti?c analysis for the
sake of good health.
results in simple terms Ÿ Full-time storage of
any type of exams
Ÿ Easy re-appointments and improvement of the
Doctor- Patient relationship
By prioritizing the patient at the center of all
processes, clinics adopt a loyalty approach,
creating a digital interface for the engagement
of patients and health professionals. Medcloud
can be integrated with any equipment, software
or medical device and drastically reduces the use
of printed media by the clinics, favoring the
environment with the digital sharing of
diagnostics.
/ MAY 2019 / 37
40

• The Passionate Leadership
• Medcloud was founded by Dimas Francisco Silva Jr.
  who is currently the CEO. Dimas is passionate
  about great products, teams, and patient
  experience. He thinks that great products are
  like a good music.
• Speaking highly of this team, he asserts, Its
  an easy and lovely experience and doesnt need
  any previous instruction in order to enjoy it.
  In order to enable great products, he thinks
  that only a good orchestration process and a team
  could deliver such level of quality. In other
  words, only a good orchestra could provide a
  good concert. Only a compromised and devoted
  team could create a winner service.
• Notable Awards and Accreditations
• Medcloud has received the following awards over
  the last years
• Brazilian Pharma Solutions _at_ Biominas Brasil 2018
  1st place in the Mapping of Innovations carried
  out by Apex- Brasil, Abiqui? and Biominas
  Brazil.
• Frost Sullivans 1 Cloud-Based Medical
  Solution in Latin America, 2016 Best Practices
  Award, more than an award, this title was a
  con?rmation that Medcloud has been on the right
  track to achieve its moonshots.
• Also, Medcloud is the only 100 Cloud Platform in
  the market with ANVISA and HIPAA compliance
  accreditation. The Brazilian Health Regulatory
  Agency (ANVISA) is an autarchy linked to the
  Ministry of Health this is huge and

very important for Medclouds clients. More than
o?ering a great product, the company aims to
provide a safe place to store PHI (Personal
Healthcare Information). Bright Future of
Medcloud Medcloud had an exponential growth in
the past year. The company is already operating
in 19 states inside Brazil, and has special
projects in Uruguay