Molecular diagnostic firm Mesa Biotech has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Accula respiratory syncytial virus (RSV) molecular point of care (POC) test.
Mesa Biotech has also received clinical laboratory improvements amendments (CLIA) waiver from the US regulator for the Accula RSV test.
The RSV test cassette secured approval for diagnosing both children and adult populations.
Earlier this year, the company also secured FDA clearance and CLIA waiver for Flu A/Flu B test to carry out on the Accula platform.
Mesa Biotech said the Center for Disease Control (CDC) acknowledges that the specificity and sensitivity of rapid influenza diagnostic tests (RIDT) are lesser than for viral culture and RT-PCR and vary by test.
The Accula molecular test system is claimed to offer better sensitivity, specificity and information content of laboratory-based PCR testing.
With palm-sized, reusable dock and disposable test cassettes, the Accula RSV test is also designated to be used with nasal swab collection, which is less invasive compared to nasopharyngeal swabs.
RSV is said to be an RNA virus attributable to outbreaks of respiratory tract infections. It causes cold-like illness, as well as lower respiratory infections such as bronchiolitis and pneumonia.
Mesa Biotech co-founder and CEO Dr Hong Cai said: “The addition of Accula RSV test to our Flu A/Flu B test significantly enhances our upper respiratory rapid, molecular diagnostic offerings.
“It is important to have a distinct in-office diagnosis for RSV and flu, especially in young children and the elderly to provide timely, accurate information to clinicians to ensure appropriate treatment and improved patient management.”
Earlier this month, Mesa Biotech has secured CE mark approval in the AcculaÔ RSV test, which will allow to commercialize in the European Union (EU).
Mesa Biotech is engaged in the designing, development, manufacturing and commercialization of next generation molecular diagnostic tests. The company has multiple strategic agreements for distribution in Europe and Asia.