Alere earns the first CLIA-waiver for its influenza rapid molecular test. More companies are ready to benefit from enahnced enabling platforms and have products in development awaiting approval.

1. After First Molecular
Rapid Test Approval,
Expect More
Kalorama Information believes that the broad-use approval
of the first rapid diagnostic test for influenza with a
molecular basis demonstrates the potential for molecular
POC marketplace predicted in the our report last year.
Alere™ i Influenza A & B received a CLIA (Clinical
Laboratory Improvement Amendments) waiver. We suggested the trend of decentralized testing
approaches like Alere’s product in its report, The Market and Potential for Molecular Point of
Care Diagnostics. Kalorama’s report on molecular point of care is available on our website.
This week, Alere Inc. announced that the U.S. Food and Drug Administration (FDA) granted
CLIA waiver for its Alere™ i Influenza A & B test, which allows for broad use by healthcare
providers, ranging from hospitals and physician offices to clinics and other healthcare settings.
(Alere’s announcement):
The product is currently the only molecular test to detect and differentiate influenza A and B
virus in under 15 minutes. Kalorama had indicated last
year that POC MDx technologies would hit market
near-term, and now this has been realized. There are
dozens of other companies that are also working on
Molecular POC tests, so we’d expect to see more
approvals and a competitive marketplace
The Alere i test was cleared for marketing by the FDA
in June 2014, and was made available in September for
health facilities and laboratories licensed to conduct tests of moderate complexity under the
CLIA program. With CLIA waiver, the test will be available in a significantly broader range of
healthcare settings.
“There are market
opportunities in HIV,
warfarin sensitivity, sepsis
and other areas where
actionable results matter.”

2. Molecular testing involves the extraction and analysis of DNA or RNA strands to detect
sequences associated with viral and bacterial causes of infections. The company says that unlike
polymerase chain reaction (PCR) testing, thier proprietary isothermal nucleic acid amplification
technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification,
and can therefore deliver PCR-caliber results faster. The company said the clinical
performance of Alere i Influenza A & B was established in a multi-center study conducted in the
U.S., in which 630 nasal swab specimens, were evaluated with Alere i, and compared to an FDA
cleared Real-Time PCR (RT-PCR) assay.
Kalorama believes that influenza is not the only area where a rapid product can succeed. There
are market opportunities in HIV, warfarin sensitivity, sepsis and other areas where actionable
results matter.
The report, The Market and Potential for Molecular Point of Care Diagnostics, details these
areas and the companies that have products in development. The report discuses important
platforms and the status of products, reviews deals made in the market and profiles companies in
this market. It also provides insight into the potential market for these products. Information for
this report can be found at: http://www.kaloramainformation.com/Potential-Molecular-Point-
8028587/.

3. Companies To Watch in 2015
Over 75 companies are involved in this market in a significant way. As expected with any group of start-up
companies, many are struggling or are surviving on limited financial resources. However, some new companies that
are focusing on molecular diagnostic POC testing have received significant investments.
Abacus Diagnostica Oy
Access Bio, Inc.
Ahram Biosystems, Inc.
Akers Biosciences, Inc.
Akonni Biosystems, Inc.
Alere Inc.
Amplino
Analytik Jena AG
Aquila Diagnostic Systems Inc.
Atlas Genetics Ltd
Atonomics A/S
Axxin
BD Diagnostics
Biocartis SA
BioFire Diagnostics, Inc.
bioMérieux sa
Canon U.S. Life Sciences
Cepheid
Coris BioConcept
Curetis AG
DestiNA Genomics Ltd.
Diagnostics for All (DFA)
Diagnostics for the Real World, Ltd.
DiaSorin S.p.A.
Eiken Chemical Co., Ltd.
Enigma Diagnostics Limited
Epistem
Espira, Inc.
Focus Diagnostics, Inc.
GenePOC Inc.
Great Basin Corporation
Instrumentation Laboratory
IQuum, Inc.
Life Technologies Corporation
LiquiLume Diagnostics, Inc.
Lumora Ltd
Mast Group Ltd.
MBio Diagnostics, Inc.
Meridian Bioscience, Inc.
Micronics Inc. (A Sony Group Company)
Molbio Diagnostics Pvt. Ltd.
MP Biomedicals, LLC
MycroLab Diagnostics Pty Ltd.
Nanobiosym (NBS)
Nanobiosym Diagnostics (NBSDx)
NanoBioSys Inc.
NanoDetection Technology, Inc. (NDT)
NanoIVD, Inc.
Nanomix, Inc
Nanosphere, Inc.
NetBio, Inc.
NorChip
OptiGene Ltd.
PositiveID Corporation
QIAGEN N.V
QuantuMDx Group
Quidel Corporation
Seegene, Inc.
Spartan Bioscience Inc.
Veredus Laboratories
Wave 80 Biosciences
Xagenic Inc.

4. NOW AVAILABLE FROM KALORAMA INFORMATION
The Market and Potential for
Molecular Point of Care Diagnostics
http://www.kaloramainformation.com/Potential-Molecular-Point-8028587/
The molecular diagnostic market and the point-of-care (POC) testing markets
are two of the fastest growing segments of the overall IVD market.
Historically, these have been completely different market segments. Not
anymore. There has been a growing interest in developing molecular
diagnostic platforms that can be used in POC settings. This report, The
Market and Potential for Molecular Point of Care Diagnostics, offers a
quantitative assessment of the molecular diagnostic market, and of the
point-of-care (POC) testing market, and then looks at the emerging field of
molecular diagnostic POC testing. As part of this coverage, the report
provides:
• Products in Development and Marketed
• Market Estimates for Molecular Diagnostics and POC 2013-2018
• Investments and Financing Agreements for POC Molecular
• Infectious Disease Diagnostics Opportunities
• Agreements Between with Other Diagnostic Companies
• Acquisitions of Molecular Diagnostic Near-Patient/Point-of-Care Companies
• Investor Spending in Molecular POC
• Deals Made Recently in Point of Care
• Profiles of Key Companies in the Market
Advances in molecular diagnostic technologies, combined with advances in
microfluidics and other instrumentation technologies, are making it possible
to develop new platforms and tests that meet the needs of a true POC
system. Platforms for molecular diagnostic POC testing need to be small,
portable, potentially hand-held, easy-to-use, and inexpensive. They need to
be fully automated from sample to answer, so that they can be used by
individuals who are not highly trained in molecular diagnostics or in
laboratory testing in general.
Detailed Lists of Companies, Products, Recent Deals
Market analyses in this report cover world markets for molecular diagnostic
point of care tests. However, the reader will find a bias toward the developed areas of the globe -- North America,
Japan and Western Europe. Yet, it is important to remember that health and infectious disease are a growing global
problem. Molecular diagnostic point-of-care tests represent an important aspect of bringing healthcare limited
resource settings, and some sections of this report specifically focus on these activities. Market data in this report are
based on factory sales to the end user, and not on retail pricing or reimbursement payments.