Quest Diagnostics' blood and herpes point-of-care tests receive FDA
clearance
21 November 2007 Quest Diagnostics Incorporated (NYSE:DGX) has
announced that its HemoCue and Focus Diagnostics subsidiaries have received
FDA 510(k) clearance for two new point-of-care test kits that could speed up
the time for diagnosis and allow doctors to make immediate decisions about
treatment.
The HemoCue White Blood Cell (WBC) Analyzer is a whole-blood test
performed on finger-stick samples that assists physicians diagnosing
infection, inflammation, bone marrow failure, autoimmune diseases, drug
toxicity, leukaemic neoplasia and many other medical conditions now
routinely tested for by reference laboratories.
The company also received FDA clearance for Focus Diagnostics'
HerpeSelect Express HSV-2, a test for aiding in the diagnosis of the herpes
simplex type-2 virus, the primary cause of genital herpes. This is the first
step in the regulatory process that allows the companies to market the
products and file for CLIA waivers, which would enable the tests to be used
in a much larger segment of physician offices.
The $6 billion market for point of care tests is growing an estimated
8-10% per year.
"The HerpeSelect Express HSV-2 test and HemoCue WBC Analyzer are important
technologies that underscore the growing importance of point of care tests
as complements to laboratory-based diagnostics," said Joyce G. Schwartz,
M.D., vice president and chief laboratory officer, Quest Diagnostics. "These
two tests could markedly change the speed of diagnosing infections, allowing
physicians to make immediate treatment decisions for their patients."
The HemoCue WBC Analyzer provides a count of a patient's white blood cells
in as few as three minutes using a blood sample taken from the patient's
finger tip. Unlike conventional methods which measure red and total blood
cell counts, the HemoCue WBC Analyzer is the first point of care device to
produce quantitative results of a patient's white blood cells. Changes in
white blood cell counts can help physicians detect numerous conditions and
disorders. With 510(k) clearance for marketing, physicians who operate
CLIA-certified moderately complex laboratories now may use the HemoCue WBC
Analyzer to quickly produce results during a single office visit.
HemoCue plans to apply for CLIA waiver for the HemoCue WBC Analyzer
shortly, which if granted, would permit physicians to offer the test in
CLIA-waived laboratories, which are far more prevalent than moderately
complex laboratories. The Analyzer is available worldwide. The HerpeSelect
Express HSV-2 test is designed to be simple enough for use in clinics and
other point-of-care settings, and can produce results within fifteen
minutes. The ability of physicians to provide counsel on treatment options
and lifestyle changes during a single office visit can benefit patients who
are anxious about their test results or who may be unwilling or unable to
return for a second visit to learn their results.
The prevalence of herpes has increased dramatically in the last three
decades because it is often transmitted without the knowledge of the
infected individual or the uninfected partner. Today more than 50 million
individuals in the US are infected and 90% are unaware they have the
disease. Focus Diagnostics plans to apply for CLIA-waived status for the
test this month. Focus Diagnostics is based in Cypress, California.
HemoCue AB is headquartered in Sweden and has wholly owned subsidiaries in
the UK, Finland, Germany, the Netherlands, Switzerland and the US.
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