SAN DIEGO, July 26 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq:GPRO - News) announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProFAST™+ assay, making it the only FDA-cleared molecular diagnostic test to simultaneously detect and differentiate three common influenza A virus subtypes – seasonal A/H1, seasonal A/H3, and 2009 H1N1.
"FDA clearance of our ProFAST+ assay is important for public health, as the test enables physicians to accurately differentiate among influenza A subtypes that have different antiviral susceptibilities," said Carl Hull, Gen-Probe's president and CEO. "In addition, the ProFAST+ clearance kicks off what we believe will be an important new revenue growth cycle for Gen-Probe, as its 510(k) was the first of four U.S. regulatory applications that we expect to submit before year-end."
The ProFAST+ assay is a multiplex, real-time RT-PCR (polymerase chain reaction) in vitro diagnostic test that detects influenza A from nasopharyngeal swabs. It uses the same internal control and format as other FDA-cleared Prodesse tests for respiratory infectious diseases, and easily integrates into a laboratory's existing workflow. All Prodesse products have been optimized for use with automated extraction technology that minimizes technician hands-on time. Test results can be obtained in as little as four hours using the ProFAST+ assay, a significant improvement over culture-based methods that can take days to produce a result.
Accurately differentiating among the three influenza A subtypes is important because each subtype has a different susceptibility to commonly used influenza antiviral drugs. For example, seasonal H1 has become resistant to the antiviral drug oseltamivir, whereas most cases of 2009 H1N1 and seasonal H3N2 respond to oseltamivir.
The ProFAST+ assay complements the Prodesse ProFlu™+ assay, which was cleared by the FDA in 2008 to detect and differentiate influenza A, influenza B, and respiratory syncytial virus (RSV). The ProFlu+ assay identifies samples containing 2009 H1N1 as influenza A, but unlike the ProFAST+ test, it does not differentiate among the various influenza A subtypes.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe has approximately 27 years of expertise in nucleic acid testing (NAT), and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,300 people. For more information, go to www.gen-probe.com .
In October of last year, Gen-Probe acquired Prodesse, Inc., which is now a wholly owned subsidiary of Gen-Probe. Prodesse develops molecular diagnostic reagents for a variety of infectious diseases. With the FDA clearance of ProFAST+, Prodesse now sells five FDA 510(k) cleared products in the United States, and one additional CE-marked product 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 ProFAST+ assay, its commercial acceptance, and future influenza prevalence 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 ProFAST+ assay effectively, the risk that seasonal flu will not be prevalent in this or future years, and the risk that 2009 H1N1 will not return. 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.
Vice president, investor relations and corporate communications