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Prodesse Seeks FDA OK for New Flu Assay

NEW YORK (GenomeWeb News) – Prodesse today said that it has filed for US Food and Drug Administration 510(k) clearance of its ProParaflu+ assay.

The RT-PCR assay has been developed to rapidly detect and differentiate parainfluenza viruses 1, 2 and 3. The Milwaukee, Wis.-based firm said that the new assay is its third respiratory and fourth overall real-time assay that has been submitted for FDA clearance.

"Along with ProFlu+ and Pro hMPV+ these three respiratory products with their seven detections share an internal control allowing clinicians to easily run the most appropriate series of tests for their patients from just a single nucleic acid extraction," Karen Harrington, who oversaw clinical trials for Prodesse, said in a statement.

Prodesse said that ProParaflu+ can provide results within three hours as opposed to up to several days for current methods that don't use RT-PCR.

The Scan

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