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 findings?
Scope
Key uses of POC diagnostic tests and underlying technologies: Diagnosing and screening, informing
treatment decisions, safety testing, severity subtyping, multiplexing, miniaturization, immunoassays,
PCR.