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Prodesse Receives FDA Clearance For US Marketing Of ProParaflu+ Assay

Assay detects and differentiates parainfluenza 1, 2 and 3 viruses which cause lower respiratory tract infections

Gen-Probe’s subsidiary, Prodesse has received FDA clearence for marketing its ProParaflu+ assay in the US. Its a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections.

The company claims that 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 US.

The company said that 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 optimised for use with automated extraction technology that minimises technician hands-on time. This ease-of-use enables labs to quickly validate the products. Test results can be obtained in three hours using the assays.

Eric Tardif, senior vice president of corporate strategy at Gen-Probe, and general manager of Prodesse, said: “FDA clearance of our 510(k) application for ProParaflu+ adds to Prodesse’s portfolio of molecular tests for respiratory infectious diseases. 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.”