GenePOC Inc, Quebec, Canada, a member of the Debiopharm group, has announced that FDA has recently cleared the company’s GenePOC strep A assay, to be performed on the company’s Revogene analyzer.
The GenePOC strep A assay is a qualitative in vitro diagnostic for the detection of Streptococcus pyogenes nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The assay can provide strep test results in as little as 42 minutes for positive specimens, and in approximately 70 minutes for negative specimens, without the need for culture confirmation. A test completed within an hour can enable physicians to better manage patients.
The Revogene analyzer is an automated standalone instrument that employs proprietary single-use microfluidic cartridges with fluorescence-based real-time polymerase chain reaction technology to deliver an accurate diagnosis.
“The GenePOC strep A assay demonstrated good performance during our evaluation and is a promising alternative to throat cultures and rapid antigen diagnostic tests,” says Amanda Harrington, PhD, an associate professor and medical director for microbiology at Loyola University.
“The GenePOC strep A assay can provide actionable results without the need to confirm by culture,” says Patrice Allibert, CEO of GenePOC. “GenePOC is committed to developing important assays to complete its current offering, becoming a strong player in the field of rapid molecular diagnostics.”
For further information, visit GenePOC.
Featured image: PIE test cartridge used with the Revogene analyzer. Image courtesy GenePOC.