• GenePOC Obtains FDA Clearance for its GenePOC™ Strep A Test in the US

    • March 25, 2019
    • Posted By : admin
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    The GenePOC Strep A assay is a qualitative in vitro diagnostic test 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 results as early as 42 minutes for positive specimens and in approximately 70 minutes for negative specimens, without the need for culture confirmation.

    “The GenePOC Strep A assay demonstrated good performance during our evaluation and is a promising alternative to throat cultures and Rapid Antigen Diagnostic Tests (RADT).”
    Amanda Harrington, Medical Director of Microbiology at the Loyola University in Chicago.

    It is important to note that about 11 million patients in the US are diagnosed with pharyngitis in the emergency room3. More importantly, over 70% of pharyngitis have a viral cause4. A test completed within an hour can allow physicians to better manage patients.

    “The GenePOC Strep A assay can provide actionable results without the need to confirm by culture. GenePOC is committed to developing important assays to complete its current offering, becoming a strong player in the field of rapid molecular diagnostics.”
    – Patrice Allibert, CEO of GenePOC

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