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Mesa Biotech to Present Comparative Flu & RSV Detection Analysis with Other FDA-Cleared Molecular Assays at AACC


Mesa Biotech Inc. is a privately-held, molecular diagnostic company that has developed the Accula™ System, an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis. Today, Mesa Biotech announced it will present performance comparisons of its visually read PCR testing platform with other FDA-cleared molecular tests for influenza A/B and respiratory syncytial virus (RSV) assays. The lecture will take place on August 6, 2019 at 1:00 pm in theater 3 of the exhibit hall at the 71st American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo in Anaheim, CA. Additionally, the Accula System's RSV and Flu A/Flu B molecular tests will be on exhibit in Booth 3902 at AACC.

"Antiviral drug treatments are becoming increasingly popular and more widely used. The antivirals work best when taken within 48 hours of symptom onset, therefore highly accurate, POC testing is crucial for healthcare professionals to achieve rapid and accurate confirmation of the infection to enable the best patient outcome," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc.

Stephen Young, PH.D., Director of Research and Clinical Trials at TriCore Reference Laboratory will present the session titled 'Sample-to-answer, CLIA-waived PCR System with Visually Read Results for POC: Comparative Flu and RSV Detection Analysis with Other FDA-cleared Molecular POC Assays'. The presentation will provide a technology overview and performance characteristics of the visually interpreted, CLIA-waived Accula System that possesses the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays. Additionally, Dr. Young will provide insight on the user experience with the Accula System.

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and single-use, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the US by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia.

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