Diagnostic products maker Gen-Probe Inc (GPRO) has submitted a Pre-market Approval (“PMA”) application to the U.S. Food and Drug Administration (FDA) for its APTIMA assay for the detection of human papillomavirus (“HPV”) infections. This represents the last of the five regulatory submissions the company planned to complete in the U.S. in 2010. The APTIMA HPV assay is currently marketed in Europe.
HPV is one of the most prevalent sexually transmitted infections in the U.S. Roughly 20 million Americans are affected by HPV infection. HPV are common viruses, which could expose infected women at high risk of developing precancerous lesions of the cervix, eventually lead to cervical cancer. Although there are more than 100 types of such viruses, 14 of them have been found to be capable of causing cervical cancer.
According to the American Cancer Society, more than 12,000 women would be diagnosed with cervical cancer in the U.S. in 2010, and over 4,000 of them would succumb to it. Since all HPV infections do not lead to cancer, specific tests are required to detect women who are at high risk of developing cervical cancer.
Currently, the Papanicolaou (“Pap”) test is widely used for the screening of cervical cancer in the U.S. The test is performed by collecting samples of cervical cells and then sending them to a laboratory for analysis to detect abnormal cells (which exhibits precancerous changes in cells).
Although the Pap test is effective in preventing cervical cancer and reducing associated mortality, it has its shortcomings including failure to detect cell changes due to sampling and interpretation errors. As such, regular and repeated tests are required to effectively detect cervical cancer.
The APTIMA HPV assay, a novel molecular test, possesses the ability to detect 14 HPV types that can cause cervical cancer. Based on the clinical study results, the assay offers greater sensitivity in detecting cancer and precancerous lesions than the legacy Pap test.
Moreover, the APTIMA HPV assay can be used with Gen-Probe’s TIGRIS system, the only fully automated testing system for molecular diagnostics. This will offer a convenient way to physicians and laboratories to provide fast and accurate detection of infectious diseases. Gen-Probe is seeking FDA approval to run APTIMA HPV assay on the TIGRIS system.
California-based Gen-Probe has been a pioneer in the commercial and scientific development of nucleic acid testing (“NAT”) for the diagnosis of infectious diseases. It is a market leader in domestic gonorrhea and chlamydia testing with its PACE and APTIMA assay product lines.
Gen-Probe is a leading pure-play molecular diagnostics company. The company’s molecular diagnostic tests and instruments are designed to improve results and increase laboratory operating efficiency. Gen-Probe competes with more established firms in the molecular diagnostic industry such as Roche (RHHBY), Becton Dickinson (BDX) and Abbott Labs (ABT).
Molecular testing enables real-time detection of the primary cause of a disease at the molecular level. The global market for molecular diagnostic tests currently exceeds $3 billion and is forecasted to reach roughly $5 billion by 2011.
Gen-Probe is positioned to benefit from the ongoing market shift away from traditional diagnostic methods (such as antibody-based assays) toward molecular testing, which offers greater precision and sensitivity in detecting biological events. Currently, we are Neutral on Gen-Probe.
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