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Mesa Biotech RSV Test Wins CE Mark

NEW YORK (GenomeWeb) – Mesa Biotech announced today that it has received CE marking for its molecular diagnostic assay to detect respiratory syncytial virus (RSV). The point-of-care test will now be will marketed by select distributors in the EU.

The Mesa RSV assay uses nasal swabs, considered to be a more comfortable specimen to collect from patients — particularly children — than nasopharyngeal swabs. The test runs on Mesa's Accula system, which is a palm-sized, reusable dock with disposable test cassettes. The platform offers the procedural familiarity of traditional POC rapid immunoassays with the sensitivity and specificity of lab-based PCR testing, according to the firm.

The RSV test is the firm's second to receive CE marking. The Accula Flu A/Flu B Test obtained a CE mark, 510(k) clearance from the US Food and Drug Administration, and a CLIA waiver earlier this year.

"We are excited to introduce the second test in our PCR-based infectious disease diagnostic portfolio in the EU," Mesa Cofounder and CEO Hong Cai said in a statement. "Accula RSV brings reference laboratory performance to the point of care, enabling clinicians to quickly and accurately diagnosis and treat their patients."

According to a study published in The Lancet in 2017, the global burden of RSV-associated acute lower respiratory infection in 2015 was approximately 33 million cases, requiring more than 3 million hospitalizations and causing almost 60,000 in-hospital deaths in children younger than five.