Healthcare Industry News:  Real-Time PCR 

Diagnostics FDA

 News Release - October 29, 2009

FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)

Assay Detects 2009 H1N1 Influenza Virus, Aided by an Algorithm that Relies on Seasonal Influenza A/H1 Virus and Seasonal Influenza A/H3 Virus Results

SAN DIEGO, Oct. 29 (Healthcare Sales & Marketing Network) -- Gen-Probe Incorporated (Nasdaq: GPRO ) today announced that the US Food and Drug Administration (FDA) has granted an EUA (emergency use authorization) for its test, the Prodesse ProFlu-ST(TM), 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.

With the EUA, ProFlu-ST becomes the first commercially available RT-PCR (polymerase chain reaction) test that can detect and identify the 2009 H1N1 influenza virus, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, for the duration of the declared public health emergency. Because the three influenza A subtypes currently have different susceptibilities to influenza antiviral drugs, this capability is important for clinicians and patients during this flu season.

The Real-Time PCR technology used in ProFlu-ST is simple to use and easily integrates into a lab's existing workflow. The product has been optimized for use with automated extraction technology that minimizes technician hands-on time. This ease-of-use enables labs to quickly validate the product for use. Test results can be obtained in as little as three hours using the assay - 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.

Andy Shrago, head of marketing for Prodesse products, said, "Many experts are expecting continued high levels of 2009 H1N1 infections through this next flu season, along with a return of either or both of the seasonal flu strains, so we believe that with this EUA, ProFlu-ST can help provide top-notch care. This test complements nicely our FDA cleared ProFlu+(TM) Assay, which from a single sample, detects and discriminates influenza A virus, influenza B virus and RSV."

About the FDA's Emergency Use Authorization

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 emergency use authorizations 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 emergency use authorization 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, 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.

About Gen-Probe

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.

On October 21, 2009, Gen-Probe completed its previously announced acquisition of Prodesse, Inc. Now a wholly-owned subsidiary of Gen-Probe, Gen-Probe 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 two additional CE-marked products in Europe.

Prodesse's ProFlu+(TM) test was cleared by the FDA in January 2008 for the detection and discrimination of Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus. It is the only commercially available, FDA-cleared molecular test for these respiratory viruses that uses Real-Time PCR technology.

Prodesse also sells FDA-cleared, Real-Time PCR assays for the clinical diagnosis of Clostridium difficile (C. diff), a bacterium that is the most serious cause of antibiotic-associated diarrhea, and human metapneumovirus, a common cause of lower respiratory infection in children.

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 ProFlu-ST or 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 ProFlu-ST 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.

Source: Gen-Probe

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