RSV Test Represents Expansion of FDA Cleared, CLIA-Waived and CE Marked
“We are excited to launch our second Accula point-of-care test at AACC,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “Similar to influenza, RSV requires a prompt and accurate diagnosis at the POC so treatment can begin, making our RSV test an important addition to our sample-to-answer PCR testing platform.”
Respiratory syncytial virus is an RNA virus attributable to outbreaks of respiratory tract infections. RSV infections can occur throughout the year, but typically peak during the winter months. Studies indicate that nearly 100 percent of children will suffer from RSV infections by age two. RSV viruses not only cause upper respiratory tract infections but also bronchiolitis of the lower respiratory tract, which often becomes severe in infants and toddlers with underlying diseases. Diagnosis of RSV is difficult because the initial symptoms can be similar to those caused by other infectious agents. Considering the RSV virus is highly contagious, accurate diagnosis and prompt treatment of patients can have a positive effect on public health.
About Accula™ System
The Accula System, recently named 2019 Frost & Sullivan Price/Performance Global Value Leader, is a sample-to-answer palm-sized, reusable dock with single-use test cassettes. The novel molecular test system is a visually interpreted, FDA cleared, CLIA-waived PCR platform with the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassay tests, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Both the Accula Flu A/Flu B and RSV tests are 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.
About Mesa Biotech Inc.
Mesa Biotech designs, develops, manufactures and commercializes 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™ Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the US by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia. For more information visit http://www.mesabiotech.com