First step for performing important diagnostics in physician offices
MADISON, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Quest Diagnostics
Incorporated (NYSE: DGX), the nation's leading provider of diagnostic testing,
information and services, today announced that its HemoCue and Focus
Diagnostics subsidiaries have received FDA 510(k) clearance for two new point
of care tests. The HemoCue(R) 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, leukemic neoplasia and many other medical conditions now routinely
tested for by reference laboratories. The company also received FDA clearance
for Focus Diagnostics' HerpeSelect(R) Express(TM) 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 eight percent
to ten percent a 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 U.S. are
infected and 90 percent are unaware they have the disease. Focus Diagnostics
plans to apply for CLIA-waived status for the test within the next two weeks.
With FDA 510(k) clearance, manufacturers may market their diagnostic
device for use in moderately complex laboratories, as defined by the Clinical
Laboratory Improvement Amendments (CLIA), which establish standards for
diagnostic testing in the U.S. 510(k) clearance also enables manufacturers to
submit the test for review by the FDA for CLIA-waived status. A test that is
CLIA waived fulfills certain criteria, such as ease of use, that make it
suitable for operation by non-laboratory trained staff in physician offices
and clinics.
About Focus Diagnostics, Inc.
Focus Diagnostics, Inc., is an infectious disease diagnostics company,
providing reference laboratory services to hospitals and laboratories
nationwide and manufacturing and distributing diagnostic products worldwide.
Focus Diagnostics develops innovative products for diagnosing infectious
diseases, and often provides the first commercially available diagnostic tests
in the U.S. for emerging diseases such as West Nile Virus and SARS.
HerpeSelect(R) type-specific HSV serology and West Nile Virus DxSelect(TM) are
top-selling Focus Diagnostics products used in laboratories worldwide. Focus
Diagnostics is a wholly owned subsidiary of Quest Diagnostics Incorporated.
Visit www.focusdx.com for additional information.
About HemoCue AB
HemoCue, a Quest Diagnostics company, is a leading global company in a
field of diagnostics known as near patient, or point of care, testing. In
1982, HemoCue introduced the first system making accurate hemoglobin testing
possible in near patient settings. Since then, HemoCue has sold more than
250,000 systems worldwide and sells more than 100 million cuvettes annually.
The company also manufactures point of care tests for glucose and urine
albumin. The company has wholly owned subsidiaries in England, Finland,
Germany, the Netherlands, Switzerland and the U.S., with franchises and third-
party distributors generating revenue in more than 100 countries. Quest
Diagnostics acquired HemoCue in 2007. HemoCue is based in Angelholm, Sweden.
Additional information is available at www.hemocue.com.
About Quest Diagnostics
Quest Diagnostics is the leading provider of diagnostic testing,
information and services that patients and doctors need to make better
healthcare decisions. The company offers the broadest access to diagnostic
testing services through its national network of laboratories and patient
service centers, and provides interpretive consultation through its extensive
medical and scientific staff. Quest Diagnostics is a pioneer in developing
innovative new diagnostic tests and advanced healthcare information technology
solutions that help improve patient care. Additional company information is
available www.questdiagnostics.com.
This communication contains certain forward-looking statements. These
forward-looking statements, which may include, but are not limited to,
statements concerning the proposed acquisition, are based on management's
current expectations and estimates and involve risks and uncertainties that
could cause actual results or outcomes to differ materially from those
contemplated by the forward-looking statements. Certain of these risks and
uncertainties may include, but are not limited to the risks and uncertainties
described in the Quest Diagnostics Incorporated 2006 Form 10-K and subsequent
filings.
SOURCE Quest Diagnostics Incorporated
CONTACT: Investors: Laure Park, +1-973-520-2900, or Media: Wendy Bost,
+1-973-520-2800, both of Quest Diagnostics Incorporated /
/Web site: http://www.questdiagnostics.com
http://www.hemocue.com
http://www.focusdx.com /