H1N1 swine flu test kit Prodesse ProFlu-ST for rapid detection of pandemic virus gets emergency approval in US: Gen-Probe

Prodesse ProFlu-ST, a laboratory test kit to quickly diagnose 2009 H1N1 pandemic swine flu, granted emergency approval in US, its maker Gen-Probe Inc said in a new release.

Prodesse ProFlu-ST test can diagnose H1N1 swine flu in as little as three hours, while tests using throat cultures can take weeks.

US FDA granting of emergency approval for Prodesse ProFlu-ST test will give Gen-Probe Inc to market the dignostic kit for the entire duration of the declared public health emergency related to swine flu which is set to expire on April 26, 2010.

Prodesse ProFlu-ST utilizes assay detection method to identify 2009 H1N1 influenza virus, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results.

Prodesse ProFlu-ST is meant to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, from a single sample in individuals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices.

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.

With the emergency use authorization (EUA), ProFlu-ST becomes the first commercially available RT-PCR (polymerase chain reaction) test that can detect and identify the 2009 H1N1 influenza virus.

ProFlu-ST is simple to use and easily integrates into a lab’s existing workflow.

Prodesse ProFlu-ST 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.

Speedier dignosis of H1N1 swine flu and the exceptional sensitivity of molecular testing are extremely important from an infection control perspective during a public health emergency, Gen-Probe 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,” stated Andy Shrago, head of marketing for Prodesse products, Gen-Probe.

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.

Recently, US FDA has given EUA to BioCryst’s intravenous HIN1 swine flu drug peramivir.
Gen-Probe Incorporated is a leader in manufacture and marketing of rapid 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+ 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.