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Gen-Probe Receives FDA Approval For Prodesse’s ProParaflu+ Assay

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

Gen-Probe Incorporated (Gen-Probe) has announced that Prodesse’s ProParaflu+ assay has received US Food & Drug (FDA) approval. This assay is a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections. Prodesse is a wholly-owned subsidiary of Gen-Probe, a company engaged in molecular diagnostics.

Eric Tardif, Gen-Probe’s senior vice president of corporate strategy 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.

“Although parainfluenza virus infections aren’t serious in most people, they can cause dangerous complications in young children, the elderly and other patient groups. 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.”

The 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.

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 optimized for use with automated extraction technology that minimizes 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 whereas culture-based methods can take up to weeks to produce a result, said the company.