FDA Grants CLIA Waived Status to Cholestech for New Combined Test Panel
July 12 2007 - 12:08PM
PR Newswire (US)
Statin Prescribers in the US to Benefit from Lipid Profile and ALT
in One Quick and Accurate Test HAYWARD, Calif., July 12
/PRNewswire-FirstCall/ -- Cholestech Corporation (NASDAQ:CTEC), a
leading provider of alternate site health management solutions for
chronic disease, announces that the FDA has granted CLIA waived
status to the Company's newest test panel, Lipid Profile ALT. The
new test panel, designed for use with the Cholestech LDX(R) System,
combines an ALT test with a lipid profile, providing total
cholesterol, HDL cholesterol, LDL cholesterol, triglyceride and
alanine aminotransferase (ALT) results from a single fingerstick.
(Photo: http://www.newscom.com/cgi-bin/prnh/20060504/NYTH042) By
testing at the point of care, the Lipid Profile ALT test allows
physicians in the US to immediately assess elevated cholesterol
levels and liver damage at the same time allowing for medication
dosage adjustments and safety monitoring on-the-spot. In office
testing improves patient adherence as a result of the strong impact
of a face-to-face exchange between patient and physician as opposed
to the delays associated with sending samples to off-site labs. The
new test panel also increases office efficiency and patient comfort
by cutting analysis time in half when compared to performing the
tests separately -- results are generated from just one fingerstick
and available within five minutes. Independent market research
reveals that with the availability of the Lipid Profile ALT
cassette, 61 percent of physicians will increase the amount of
in-office testing they do. "The new test panel provides physicians
who are prescribing statins with valuable access to quick and
accurate results for better management of patient adherence and
side effects," said Warren E. Pinckert II, Cholestech President and
CEO. "The CLIA waiver that the FDA granted to the Lipid Profile ALT
cassette provides physicians with confidence in the accuracy of the
results they see for each and every patient." About CLIA and CLIA
Waiver The Clinical Laboratory Improvement Amendments (CLIA) of
1988 established quality standards for laboratory testing to ensure
the accuracy, reliability and timeliness of patient test results
regardless of where the test was performed. CLIA waived tests are
recognized by the FDA to be so simple to use and so accurate that
there is little risk of error. As a result, those using CLIA waived
tests are not subject to the more stringent and expensive
requirements of moderate or high complexity laboratories. Before
running a waived test, a CLIA Certificate of Waiver must be
obtained from the Centers for Medicare & Medicaid Services
(CMS). CLIA requirements differ by state and for physician offices,
pharmacies and hospitals. Contact your state CLIA office to learn
about CLIA requirements for your health organization. About
Cholestech Cholestech is committed to enabling people to lead
longer, healthier and more active lives. Cholestech provides easy
to use, accessible diagnostic tools and information to health care
practitioners in over 35 countries around the world. Cholestech
offers efficient and economic diagnostic testing for cholesterol
and related lipids, blood glucose and glycemic control, and liver
enzymes at the point of care. Health care providers can use the
CLIA waived Cholestech LDX(R) and GDX(TM)* Systems and the hs-CRP
test, which is cleared by the FDA for use in moderate complexity
labs, to initiate and monitor the progress of patient therapy. By
providing effective disease management solutions, Cholestech's goal
is to be a leading provider of diagnostic tools and information for
immediate risk assessment and therapeutic monitoring of heart
disease, inflammatory disorders and diabetes. *The GDX system is
510(k) cleared for prescription home use and, accordingly, is CLIA
waived. Cholestech LDX is a registered trademark and Cholestech GDX
is a trademark of Cholestech Corporation. All other trademarks
mentioned in this document are the property of their respective
owners. For more information about Cholestech and its products
visit us on the web at http://www.cholestech.com/. Contact: Angie
Cecil HLD/Blankman Public Relations (516) 536-6811
http://www.newscom.com/cgi-bin/prnh/20060504/NYTH042
http://photoarchive.ap.org/ DATASOURCE: Cholestech Corporation
CONTACT: Angie Cecil of HLD-Blankman Public Relations,
+1-516-536-6811, , for Cholestech Corporation Web site:
http://www.cholestech.com/
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