FDA Approves Gen-Probe Assay

| About: Hologic, Inc. (HOLX)

Recently, Gen-Probe Inc. (NASDAQ:GPRO) announced that it has received the green light from the U.S. Food and Drug Administration (FDA) to market ProParaflu Plus assay. The assay, developed by Prodesse, a wholly-owned subsidiary of Gen-Probe, is a molecular test for detecting and differentiating parainfluenza 1, 2, and 3 viruses that cause lower respiratory tract infections.

The assay makes use of real-time polymerase chain reaction to identify parainfluenza 1, 2, and 3 viruses from nasal swabs. Since it utilizes the same internal control as Prodesse's other tests for respiratory infectious diseases, a single nucleic acid extract can be tested with any combination of its other products which have received FDA clearance - ProFlu Plus, Pro hMPV Plus and ProFlu-ST.

As a reminder, ProFlu Plus received FDA approval in 2008 for detecting and differentiating influenza A and B viruses and respiratory syncytial virus (RSV). Pro hMPV Plus got FDA clearance in the same year to detect human metapneumovirus. ProFlu-ST is available for use under an FDA emergency use authorization in CLIA (Clinical Laboratory Interstate Act) high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus.

We believe that the addition of ProFlu Plus to Gen-Probe’s already established product portfolio of molecular tests for respiratory infectious diseases further enhances its reputation in the field of molecular diagnostics. It will aid doctors in the accurate identification of parainfluenza virus infections, particularly when the prevalence of other viruses is on the higher side. Management further stated that results from tests using the company’s assays can be obtained within three hours as against a week taken by culture-based methods to come out with a result.

Gen-Probe Inc., a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid testing (NAT) products that are used for the diagnosis of human diseases and for screening donated human blood. The utilization of the NAT technology has enabled the company to obtain FDA approvals for more than 40 products that detect a wide variety of infectious microorganisms such as strep throat, pneumonia and fungal infections. The company competes with players like Abbott Laboratories (NYSE:ABT) and Roche (OTCQX:RHHBY).