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Primerdesign, GenePOC Partner on Near-Patient Flu/RSV MDx

NEW YORK (GenomeWeb) – Primerdesign, the molecular testing division of clinical diagnostics firm Novacyt, has made an agreement to develop an influenza and respiratory virus clinical assay with GenePOC, the firms announced today. 

Primerdesign — which was acquired by Novacyt in 2016 — will develop a triplex molecular diagnostic test for influenza A, influenza B, and respiratory syncytial virus, to be run on GenePOC's Revogene instrument. After Primerdesign completes the assay development, GenePOC will subsequently seek CE-IVD marking and US Food and Drug Administration clearance for the flu/RSV test.

GenePOC has previously received FDA clearance an assay to detect Clostridium difficile, and clearance for a neonatal diagnostic assay for Group B Strep.

The fully automated, compact Revogene instrument performs sample prep, amplification, and detection of target sequences using fluorescence-based qPCR and single-use microfluidic cartridges called PIEs. Tests have a total run time of 70 minutes and the instrument can process eight samples at a time, detecting up to 12 targets per sample. 

"GenePOC is an ideal partner given their expertise in developing accurate and cost effective molecular solutions to detect infectious diseases," Novacyt Group CEO Graham Mullis said in a statement.

GenePOC CEO Patrice Allibert added that the firm was "impressed with Primerdesign's ability to rapidly develop assays and track record of CE marking diagnostic tests," noting that combining Primerdesign's multiplexed respiratory disease assay and the near-patient Revogene platform may improve clinical outcomes for patients around the world.