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Quest Diagnostics Receives First FDA Clearance for H1N1 MDx Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today announced that Quest Diagnostics' Simplexa Influenza A H1N1 test has received 510(k) clearance, making it the first test to receive clearance from the agency for the virus.

As a result, the test will be the only one allowed to be marketed in the US after late June.

Previously, tests for 2009 H1N1 Influenza were available only through Emergency Use Authorization, which allows the FDA to authorize unapproved or uncleared medical products, or unapproved or uncleared uses of approved or cleared medical products, while a medical emergency is in effect.

The US Department of Health and Human Services declared a public health emergency stemming from the 2009 H1N1 virus outbreak on April 26, 2009. The declaration will expire on June 23. When that happens, all tests that have been made available as a result of the EUA program will no longer be allowed to be marketed, except for Quest's Simplex test, an FDA spokeswoman said.

The test was developed and is manufactured by Quest's Focus Diagnostics business, and is the first test cleared by the FDA as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

Other companies with tests that received FDA EUA for the virus include Gen-Probe, Roche, Prodesse, DxNA, and TessArae.

The Simplexa test runs on the 3M Integrated Cycler under an exclusive global distribution agreement between Focus Diagnostics and 3M. It uses real-time reverse transcription PCR to detect RNA of the H1N1 flu virus in nasal or nasopharyngeal specimens from patients, and then reports whether 2009 H1N1 or influenza A is present in the specimen. According to Quest, other flu tests can detect the presence of influenza A but cannot differentiate the presence of 2009 H1N1.

The FDA noted in a statement that while a positive result from the Simplexa test indicates 2009 H1N1 infection, the test does not indicate the state of infection. A negative Simplexa test also does not necessarily mean a patient does not have the virus, the agency said.

According to the US Centers for Disease Control and Prevention, an estimated 43 million to 88 million cases of 2009 H1N1 occurred between April 2009 and March 13, 2010.

While H1N1 has not become a widespread public health problem, "reliable detection continues to be important to help manage high-risk patients, such as expectant mothers who have flu-like symptoms," Jay Lieberman, medical director, infectious diseases, at Quest and Focus Diagnostics, said in a statement.

Focus Diagnostics was the first company to receive EUA from the FDA for a commercial H1N1 test, and the first to launch a commercial test kit for qualitatively detecting RNA of the 2009 H1N1 virus by RT-PCR.

The first molecular diagnostic panel which received an FDA EUA for 2009 H1N1 was from the CDC.

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