SAN DIEGO, CA – April 18, 2017 – Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed a testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it will preview its novel Accula™ System for POC molecular diagnostics at the 27th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held April 22 – 25, 2017 in Vienna, Austria. The Accula Dock and Accula Flu A/Flu B test cassette will be previewed in Booth 79. The platform, not yet for sale, is expected to receive CE Mark approval and be available for distribution in Europe this summer.
In preparation for product launch, Mesa Biotech has been recommended for ISO 13485:2003 Certification. This designation confirms the company’s Quality Management System for medical devices responds to the rigorous standards of design, development, and production of devices intended for rapid diagnosis of infections at POC. This certification is a precursor to a CE mark for the Accula flu test and its commercialization in the EU.
“We are pleased to introduce our Accula dock and disposable cassette at the EECMID Congress where the world’s leading experts gather to discuss the latest developments in infectious diseases, infection control and clinical microbiology. It is a great opportunity to showcase our innovative POC system as well as continue to develop commercialization relationships,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “This past year we have focused on getting our manufacturing facility up and running, securing ISO certification, and preparing for commercial launch. These are important milestones in Mesa Biotech’s strategy to obtain CE marking for our first product and will provide an important level of assurance to clinicians and patients who benefit from this medical advancement.”
About Mesa Biotech Inc.
Mesa Biotech is an emerging molecular diagnostic company, bringing the superior diagnostic performance of nucleic acid 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 in 30 minutes or less with greater sensitivity and specificity than many 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.
