GPRO GoPro Inc

Diagnostic products maker Gen-Probe Inc (GPRO) has received the green signal of the U.S. Food and Drug Administration (“FDA”) for its APTIMA assay for the detection of human papillomavirus (“HPV”) infections which are associated with cervical cancer. The company filed a pre-market approval (“PMA”) application for the test with the FDA in late 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 to high risk of developing precancerous lesions of the cervix, eventually leading 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. 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.

The APTIMA HPV assay, a novel molecular test, can detect 14 HPV types which are associated with cervical cancer. Based on the clinical study results, the assay offers greater specificity in detecting cancer and precancerous lesions than the most commonly used FDA-approved DNA-based test.

Moreover, the APTIMA HPV assay has been approved by the FDA for use 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 plans to launch the APTIMA HPV assay in the U.S. within a couple of weeks and expects to book first sales in late first-quarter 2012.

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). Currently, we are Neutral on the stock.

 
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