Recent headlines and news reports have already ensured that the upcoming flu season is going to be one of the most significant in recent history. With all the attention that H1N1 is getting it's no wonder that such a huge spotlight is being put on the various flu strains that are poised to plague the public.
A new test from Cepheid (Sunnyvale, California) is due to get its chance in the spotlight too, since the company is calling it one of the first tests that can actually differentiate between each strain of influenza in a record time of 45 minutes.
The company was able to receive an Emergency Use Authorization (EAU) by the FDA, for its Flu A Panel test for use on the GeneXpert System. The test is poised to provide a distinction in the specific presumptive identification of Seasonal H1, seasonal H3 and H1N1 novel strain types.
"This test really comes in response to the needs of the time," David Persing VP chief medical and technology officer at Cepheid told Medical Device Daily. "This is likely going to be a very confusing influenza season."
The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met.
Subsequent to the EUA request for consideration by the FDA, the test would be made available in Europe as a CE IVD product, said the company.
Following the EUA request to the FDA, development of Flu Panel test would continue by adding additional target identification for Flu B. For that product, a separate 510(k) submission is expected in 2010, according to a report from the FDA.
Persing said that the test is set to improve on other polymerase chain reaction (PCR) tests in the market.
"What we hope to provide is the same level of convenience, with a higher level of (accuracy)," Persing told MDD.
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents what the company calls a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination.
The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.
Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment. Previously the company received clearance from the FDA to market the Xpert C. difficile test to run on the Gene Xpert System.
But while Cepheid one of the first companies to develop such a test, it isn't the first to develop a test.
The first test to identify the different strains of influenza was developed by Focus Diagnostics (Cypress, California) the infectious disease division of Quest Diagnostics (Madison, New Jersey). The company said it released its lab-developed influenza A H1N1 (2009) Real Time RT-PCR in August (Medical Device Daily, Aug. 21, 2009).
Focus' test qualitatively detects the RNA of the 2009 H1N1 influenza virus from a patient's nasal, nasopharyngeal or throat specimen. In combination with clinical and epidemiological assessments, the test aids physicians in diagnosing patients infected with the pandemic virus rather than other influenza A strains.
The test uses reverse transcriptase polymerase chain reaction, or RT-PCR, to amplify viral RNA to make it detectable in a specimen. It targets two separate regions of the hemagglutinin (H1) gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal human influenza A virus. If RNA of influenza A virus and the 2009 Influenza H1 gene are detected, the specimen is reported as positive for 2009 H1N1 influenza infection.
Omar Ford, 404-262-5546;