SAN DIEGO, November 12 /PRNewswire/ -- -- Molecular Test Differentiates 2009 H1N1 Influenza Virus from Two Common Seasonal Strains --
Gen-Probe Incorporated today announced that Prodesse's ProFlu-ST(TM) assay, a molecular test that detects the 2009 H1N1 influenza virus and differentiates it from two common seasonal strains, has received its CE (Conformite Europeenne) Mark, enabling it to be commercialized in the European Union.
Prodesse is a wholly-owned subsidiary of Gen-Probe, a global leader in molecular diagnostics.
Many experts expect continued high levels of 2009 H1N1 infections this flu season, along with a return of either or both of the seasonal flu strains, so we believe the ability of the ProFlu-ST assay to differentiate among the strains can help physicians provide personalized care, said Steve Kondor, Gen-Probe's senior vice president of sales and marketing. This test complements Prodesse's ProFlu+(TM) assay and broadens the portfolio of products sold by our growing European sales force.
The ProFlu-ST assay uses real-time RT-PCR (polymerase chain reaction) to detect and identify the 2009 H1N1 influenza virus, the seasonal influenza A/H1 virus, and the seasonal influenza A/H3 virus. Because these three influenza A subtypes currently have different susceptibilities to antiviral drugs, identifying the specific strain can help clinicians treat patients appropriately.
Gen-Probe expects that the ProFlu-ST assay will often be used in conjunction with Prodesse's ProFlu+ assay, which was CE-marked in 2007. The ProFlu+ test detects and discriminates influenza A virus, influenza B virus and Respiratory syncytial virus (RSV). A single patient sample is sufficient for testing with both the ProFlu-ST and ProFlu+ assays.
The real-time RT-PCR technology used in both assays is simple to use and easily integrates into a lab's existing workflow. Both products have been optimized for use with automated extraction technology that minimizes technician hands-on time. This ease-of-use enables labs to quickly validate the products. Test results can be obtained in as little as three hours using the assays - a significant improvement over culture-based methods that can take up to weeks to produce a result. During a public health emergency, this speed to result and the exceptional sensitivity of molecular testing are extremely important from an infection control perspective.
As previously announced, the US Food and Drug Administration (FDA) has granted an EUA (emergency use authorization) for the Prodesse ProFlu-ST assay to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single sample in individuals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices.
The US Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA has issued EUAs to make important diagnostic and therapeutic tools available to public health and medical personnel in order to identify and respond to the 2009 H1N1 influenza virus under certain circumstances.
The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products following a determination and declaration of emergency, provided certain criteria are met. In the case of the ProFlu-ST assay, the FDA has only authorized its use for the duration of the emergency, which is currently set to expire on April 26, 2010, unless it is terminated, revoked sooner or renewed.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening.
In October, Gen-Probe completed its acquisition of Prodesse, Inc. Prodesse develops molecular diagnostic reagents for a variety of infectious disease applications. Prodesse sells three FDA 510(k) cleared products in the United States, and three additional CE-marked products in Europe.
Caution Regarding Forward-Looking Statements
Any statements in this news release relating to Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning the expected benefits of the ProFlu-ST assay, its commercial uptake, and the duration of the current influenza public health emergency are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied. Some of these risks, uncertainties and assumptions include, but are not limited to, the risk that Gen-Probe will not commercialize the ProFlu-ST assay effectively in Europe, that the test may not ultimately obtain FDA clearance or approval, or that the approval would not occur prior to the expiration of the FDA's emergency use authorization. The foregoing list sets forth some, but not all, of the factors that could affect Gen-Probe's ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties Gen-Probe faces and a discussion of its financial statements and footnotes, see documents filed with the SEC, including the most recent annual report on Form 10-K and all subsequent periodic reports. Gen-Probe assumes no obligation and expressly disclaims any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact: Michael Watts Vice president, investor relations and corporate communications +1-858-410-8673
SOURCE: Gen-Probe Incorporated
CONTACT: Michael Watts, Vice president, investor relations and corporatecommunications of Gen-Probe Incorporated, +1-858-410-8673