Mesa Biotech Obtains CE Mark for its AcculaTM Point of Care Testing System
Company Launches Molecular Flu A/Flu B Test in the EU
SAN DIEGO, CA – January 24, 2018 – 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 obtained CE Mark in the European Union (EU) for its Accula™ System. 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. “The CE Mark indicates a product’s compliance with applicable EU regulations and enables the commercialization of our products. This, in turn, will provide significant benefits to clinicians and patients by offering reference laboratory performance at the point-of-care.”
According to the WHO, annual influenza epidemics are estimated to result in about three to five million cases of severe illness, and about 250,000 to 500,000 deaths. In industrialized countries, most deaths associated with influenza occur among people age 65 or older. Epidemics can result in significant work/school absenteeism and productivity losses. Clinics and hospitals can be overwhelmed during peak illness periods. The estimated economic burden of influenza-like illness ranges between $71-$163 billion in the U.S. alone.
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 private equity investments. For more information visit http://www.mesabiotech.com.