SAN DIEGO, Nov. 24 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated announced today that the US Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProParaflu+(TM) assay, a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections.
Prodesse is a wholly-owned subsidiary of Gen-Probe, a global leader in molecular diagnostics.
"FDA clearance of our 510(k) application for ProParaflu+ adds to Prodesse's portfolio of molecular tests for respiratory infectious diseases," said Eric Tardif, Gen-Probe's senior vice president of corporate strategy and general manager of Prodesse. "Although parainfluenza virus infections aren't serious in most people, they can cause dangerous complications in young children, the elderly and other patient groups. We believe our assay will be an important tool to help physicians accurately identify these infections, especially when the prevalence of other viruses is high."
The ProParaflu+ assay uses real-time RT-PCR (polymerase chain reaction) to identify the parainfluenza 1, 2 and 3 viruses from nasal swabs. The assay uses the same internal control as Prodesse's other tests for respiratory infectious diseases, so a single nucleic acid extract can be tested with any combination of these products. Prodesse markets these respiratory tests in the United States:
* ProFlu+(TM), which received FDA clearance in 2008 to detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
* Pro hMPV+(TM), which received FDA clearance in 2008 to detect human metapneumovirus.
* ProFlu-ST(TM), which is available under an FDA emergency use authorization (EUA) 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 real-time RT-PCR technology used in Prodesse's assays is simple to use and easily integrates into a lab's existing workflow. All 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.
About Parainfluenza Viruses
According to the US Centers for Disease Control and Prevention (CDC), parainfluenza viruses are second to RSV among causes of lower respiratory tract disease in young children. Similar to RSV, parainfluenza viruses can cause repeated infections throughout life, usually manifested by an upper respiratory tract illness such as a cold or sore throat. With repeat infection, parainfluenza viruses can also cause serious lower respiratory tract disease such as pneumonia and bronchitis, especially among the elderly and patients with compromised immune systems.
There are four types of parainfluenza viruses, each with different clinical and epidemiologic features. The most distinctive clinical feature of parainfluenza 1 and 2 is croup; type 1 is the leading cause of croup in children. Both parainfluenza 1 and 2 can cause other upper and lower respiratory tract illnesses, while type 3 is more often associated with bronchiolitis and pneumonia. Parainfluenza 4 is infrequently detected, possibly because it is less likely to cause severe disease.
Parainfluenza viruses are spread from respiratory secretions through contact with infected people or contaminated objects. The viruses are ubiquitous and infect most people during childhood. Parainfluenza 1 causes biennial outbreaks of croup in the fall (now during odd-numbered years in the United States). Type 2 causes annual or biennial fall outbreaks. Parainfluenza 3 activity peaks during the spring and early summer months each year, but the virus can be isolated throughout the year.
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 four 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 ProParaflu+ 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 ProParaflu+ 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.
Vice president, investor relations and