|View printer-friendly version|
|Quidel QuickVue(R) Dipstick Strep A Test Receives CLIA-Waived Status|
SAN DIEGO, July 31 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, today announced that the U. S. Food and Drug Administration (FDA) has granted a CLIA waiver for the Company's QuickVue(R) Dipstick Strep A test for use in waived physician office laboratories. The CLIA-waiver greatly expands the test's potential user base because it allows the QuickVue test to be administered in more than 100,000 physician offices/laboratories in the United States rather than only in larger laboratories.
The QuickVue Dipstick Strep A test is intended for use as an aid in the diagnosis of Group A Streptococcal infection, a common bacterial infection associated with "strep throat." Classic symptoms include the abrupt onset of sore throat accompanied by fever, fatigue and headache. The test is simple to use and provides results in 5 minutes or less in an easy-to- read, user-friendly format.
The QuickVue Dipstick Strep A is the newest addition to Quidel's family of rapid strep A tests. The other tests include the first CLIA-waived rapid strep A test, the QuickVue(R) In-Line(R) Strep A as well as the QuickVue + (formerly CARDS(R) Q.S.(R)) Strep A.
CLIA Waived Diagnostics
About Quidel Corporation
This press release contains forward-looking statements regarding Quidel's future activities within the meaning of the federal securities laws. These forward-looking statements involve material risks and uncertainties. Many possible factors could affect the future results and performance of Quidel's business, such that actual results and performance may differ materially. If Quidel's products fail to perform as expected, or if there is lower consumer demand for these products than expected, Quidel's financial condition and operating results may be materially and adversely affected. Quidel's financial condition and operating results may also be materially and adversely affected by a number of other factors, including, without limitation, seasonality, adverse changes (both domestically and internationally) in competitive and economic conditions, actions by the Company's distributors, manufacturing and production delays or difficulties and adverse actions or delays in product reviews by the FDA. Please see the discussion of these and other factors in Quidel's annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.