FDA OKs Gen-Probe Adenovirus Test - Analyst Blog

California-based diagnostic products maker Gen-Probe Inc (GPRO) hassecured approval from the U.S. Food and Drug Administration (FDA) for its Prodesse ProAdeno+ assay for the detection of human adenovirus infection. The assay represents the latest addition to the company's Prodesse line of molecular tests.

Gen-Probe acquired the Prodesse product portfolio through its take over of molecular diagnostic products maker Prodesse Inc in October 2009. The acquisition provided the company a portfolio of products for detecting influenza and other infectious organisms, enabling access to the respiratory and gastrointestinal infectious disease market. Higher adoption of Prodesse products continues to boost Gen-Probe's clinical diagnostic business.

Adenovirus infections commonly cause respiratory tract illness which manifests symptoms such as pneumonia, croup, pharyngitis, cough and bronchitis. However, it may also cause other ailments such as gastroenteritis, conjunctivitis and rash illness. Adenoviruses are transmitted via direct contact as well as fecal-oral and waterborne transmissions. It accounts for roughly 10% of acute respiratory infections in infants and young children.

Polymerase chain reaction (“PCR”) assays are one of the most commonly used tools for the diagnosis of human adenovirus infections. The Prodesse ProAdeno+ assay, a real-time PCR diagnostic test, possesses the ability to qualitatively detect human adenovirus DNA in samples obtained from people exhibiting symptoms of acute respiratory infection.

The test produces results in just three hours, representing a major improvement over standard viral cell culture method which may take weeks to achieve results. As such, the Prodesse ProAdeno+ assay is expected to provide the physicians an important means for rapid detection of human adenovirus infection.

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).

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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