Mesa Biotech Receives FDA 510(k) Clearance and CLIA Waiver for Its Accula™ Point of Care Flu A/Flu B Test

SAN DIEGO, Feb. 7, 2018 /PRNewswire/ -- 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, today announced that it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for its Accula™ Flu A/Flu B test. The company's Flu A/Flu B test cassette will be its first available test in the U.S. market.

"The Flu A/Flu B product is the first test cassette on our PCR testing platform to receive FDA clearance. This announcement follows our CE Mark certification and launch of our Flu A/Flu B test last month in Europe," said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. "This is an outstanding validation of our testing platform and we remain focused on additional product development and commercialization of our expandable PCR system."

According to the World Health Organization (WHO), annual influenza epidemics are estimated to result in about three to five million cases of severe illness, and 250,000 to 500,000 deaths. Diagnosis of influenza is difficult because initial symptoms can be similar to other upper respiratory virus infections. The FDA, Centers for Disease Control (CDC), and WHO all acknowledge that existing POC immunodiagnostic tests perform poorly. Rather, molecular testing is recommended, as influenza is a rapidly evolving virus. Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnosis is required to direct therapy for these viral infections.

CLIA establishes quality standards for laboratory testing to ensure the accuracy and reliability of patient test results.  CLIA waived tests must meet stringent quality requirements to be used in non-laboratory POC settings. The CLIA-waived Accula Flu A/Flu B test brings PCR testing to the POC providing a qualitative result in approximately 30 minutes to guide same day treatment decisions. The Accula Testing System 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. 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.

Mesa Biotech entered a strategic alliance in early November with Sekisui Diagnostics for exclusive product distribution rights in the U.S. and Canada. Leveraging Sekisui Diagnostics' established channels and strong reputation among healthcare providers, Mesa Biotech will have immediate access to distribution into North America markets. The Accula™ Flu A/Flu B test will be marketed by Sekisui Diagnostics under the Silaris™ brand.

About Mesa Biotech Inc.

Mesa Biotech designs, develops and manufactures 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 a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech's technology development has been funded to date by a series of grants and capital investments.  For more information visit http://www.mesabiotech.com.

SOURCE Mesa Biotech Inc.

Related Links

http://www.mesabiotech.com