Abstract
Introduction
The point-of-care (POC) diagnostics segment of the in vitro diagnostics fi eld
once largely consisted of glucosemonitoring devices. With billions of dollars
generated in revenue in the United States alone, POC testing has blossomed
into a market that incorporates diverse indications and purposes. How has the
push for personalized medicine affected change in diagnostics and
pharmaceutical companies to warrant a need to align themselves with POC
diagnostic test makers? Monitoring health at both acute and chronic disease
stages of a patient' s life, POC tests can be adapted as clinical and personal
tools to improve medical care. However, implementing POC testing to improve
health outcomes can be tricky unless regulatory and reimbursement kinks are
ironed out in the commercialization strategy for the product. Several
prospects exist for advancing POC testing, particularly as the quality of
products continues to improve and as efforts to raise awareness of the tests
increase.
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- Total revenues in 2008 for the top ten personalized medicine drugs
exceeded $6 million. What are the leading drugs of this type? How do the
revenues compare with 2007, 2006, and 2005?
- Biomarker-based diagnostics are the Achilles' heel of personalized
medicine. Simple diagnostic methods that produce reliable results can help
build a new drug market, while diagnostic methods that are challenging or too
costly or do not easily lead to conclusive options for therapeutic follow-up
can constrain the market. Where are POC diagnostics positioned in this scheme?
How are they furthering personalized medicine efforts?
- POC diagnostic tests are getting more sophisticated and more powerful.
Improved analytical quality, faster turnaround times, and easier-to-use
interfaces are three key features of the next generation of POC tests. How are
POC diagnostics changing medical practice? What market disruptions will impede
further growth?
- Dealmaking activity for POC diagnostics over the last few years has not
been particularly robust, yet more than 300 open studies are listed in
clinicaltrials.gov as of July 29, 2009. What links these two fi ndings?
Scope
- Key uses of POC diagnostic tests and underlying technologies: Diagnosing
and screening, informing treatment decisions, safety testing, severity
subtyping, multiplexing, miniaturization, immunoassays, PCR.
- Therapeutic focus: Cardiovascular disease, coagulation diagnostics, infl
uenza screening, hospitalacquired infections, blood-glucose screening.
- Companies and partnering: Diagnostics companies, consortia, collaborations
since 2006 to develop POC tests.
- Major challenges faced: Wooing physicians, navigating the regulatory maze,
mitigating payer infl uences.
- Future of POC tests as a way to monitor health: Constraints,
opportunities, thoughts on the outlook of the POC testing market.
Mentioned in This Report
- Abbott
- Abbott Diagnostics
- AstraZeneca
- AutoGenomics
- Axis Shield
- Bayer
- Becton Dickinson
- Biogen Idec
- bioMerieux
- bioLytical Laboratories
- Bio-Rad
- Biosite
- Bristol-Myers Squibb
- Cepheid
- Clinical Data
- Combimatrix
- DexCom
- eHIT
- Enigma Diagnostics
- Genelex
- Genentech
- Genethon
- GenoSafe
- GlaxoSmithKline
- Grove Instruments
- Health Frontiers
- Heart Watch
- HemoSense
- InLight Solutions
- Inverness Medical
- IQuum
- ITC
- Kimball Genetics/Third Wave Technologies
- Luminex Molecular Diagnostics (formerly Tm Biosciences)
- Medtronic
- Merck
- Meso Scale Discovery
- Nanogen (formerly Spectral Diagnostics)
- Nanosphere
- Novartis
- Novo Nordisk
- OSI Pharmaceuticals
- Osmetech Molecular Diagnostics
- Paragon Dx
- Pfi zer
- Response Biomedical
- Roche
- Roche Diagnostics
- Sensys Medical
- Siemens Medical Solutions (formerly Dade Behring)
- Takeda/Millennium Pharmaceuticals
- Transgene
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