Mesa Biotech Inc. has obtained CE Mark in the European Union for its Accula^™ System an affordable hand held PCR testing platform designed specifically for point-of-care (POC) infectious disease diagnosis. The first available test in the EU market will be the company's Flu A/Flu B Test.

Diagnosis of influenza is difficult because the initial symptoms can be similar to other upper respiratory virus infections. The FDA, CDC, and WHO all acknowledge that existing POC immunodiagnostic tests perform poorly. 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 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. 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.

"The introduction of the Accula System and its Flu A/Flu B test as our first PCR assay in the European market is an important validation of our platform and a critical strategic milestone for Mesa Biotech. Our proprietary assay design enables rapid development of a portfolio of cassettes to test for human, agricultural, food pathogens, or genetic disease targets," said Dr. Hong Cai, co-founder and CEO of Mesa Biotech.

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