Prodesse, Inc.'s ProAdeno+ Assay Cleared for US Marketing by FDA
Published: Dec 09, 2010
SAN DIEGO, Dec. 8, 2010 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing the Prodesse ProAdeno+ assay, a multiplex real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus.
"FDA clearance of our ProAdeno+ assay adds to the Prodesse portfolio of molecular tests for respiratory infectious diseases," said Eric Tardif, Gen-Probe's senior vice president of corporate strategy and marketing, and general manager of Gen-Probe's Prodesse business. "The people most susceptible to complications from adenovirus infections include pediatric and elderly populations. Our assay will be an important tool to help physicians diagnose this disease."
The 510(k) application for the ProAdeno+ assay was one of five US regulatory submissions by Gen-Probe in 2010. In addition, the ProAdeno+ assay is the third Prodesse product cleared by the FDA since Gen-Probe acquired Prodesse approximately one year ago.
The ProAdeno+ assay uses real-time PCR to qualitatively detect human adenovirus DNA in nasopharyngeal specimens obtained from people exhibiting signs and symptoms of acute respiratory infection. The test is intended for use to aid in the diagnosis of human adenovirus infection. It detects, but does not differentiate among, adenovirus serotypes 1-51.
The ProAdeno+ assay uses the same sample type as Prodesse's other respiratory infectious disease tests, so a single sample can be tested with any combination of these products. All Prodesse assays are simple to use and easily integrate into a lab's existing workflow. They have been optimized for use with automated extraction technology to minimize technician hands-on time. Test results can be obtained in as little as three hours, a significant improvement over culture-based methods that can take up to weeks to produce a result.
According to the US Centers for Disease Control and Prevention, adenoviruses are unusually stable to chemical and physical agents and to adverse pH conditions, allowing them to live outside the body for a long time. Adenoviruses are transmitted by direct contact, fecal-oral transmission, and occasionally via waterborne transmission.
Adenoviruses most commonly cause respiratory disease; however, depending on the serotype, they may also cause other illnesses, such as gastroenteritis, conjunctivitis, bladder infection, and rash illness. Symptoms of respiratory illness caused by adenovirus infection range from the common cold syndrome to pneumonia, croup, and bronchitis. Young infants and especially patients with compromised immune systems are more susceptible to severe complications of adenovirus infection. Acute respiratory disease, which was first recognized among military recruits during World War II, can be caused by adenovirus infections.
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 http://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 ProAdeno+, Prodesse now sells six FDA 510(k) cleared products in the United States.
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 ProAdeno+ assay and its commercial uptake 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 ProAdeno+ assay effectively. 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.
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SOURCE Gen-Probe Incorporated