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Mesa Biotech Demonstrated New Molecular POC Testing Platform at ECCMID

Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, demonstrated its novel Accula™ Flu A/Flu B test at the 28th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).  The System obtained CE Mark in the European Union (EU), as well as 501(k) clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA) earlier this year.

Diagnosis of influenza is difficult because initial symptoms can be similar to other upper respiratory virus infections. The patented Accula system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnostics are required to direct therapy for these viral infections.

The Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

"We are wrapping up a devastating flu season in both Europe and the U.S., reinforcing the need for a rapid and accurate POC diagnostic that enables doctors to begin the appropriate treatment as soon as possible," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. "With distributors identified in key EU markets, we are continuing to expand our distribution network for our initial Accula Flu A/Flu B test, as well as for follow-on POC diagnostics on our expandable PCR platform."

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