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Alere i RSV rapid molecular test gets FDA approval

MDBR Staff Writer Published 22 August 2016

Alere has received 510(k) clearance from the US Food and Drug Administration (FDA) for its i RSV rapid molecular test.

The new rapid molecular test has been for the detection of respiratory syncytial virus RSV infection in children and adults.

Alere i RSV is claimed to be first molecular test, which can be used at the point-of-care to detect RSV in 13 minutes or less.

Through using the firm’s Molecular In Minutes isothermal nucleic acid amplification technology (iNAT), the new test will detect the RSV virus in nasopharyngeal (NP) swab samples.

Alere i platform also includes i Influenza A & B and Alere i Strep A rapid molecular tests, which already received FDA approval.

The company is also planning to submit an application for Clinical Laboratory Improvement Amendments (CLIA) waiver for i RSV test.

Alere said that its i testing applications have previously been CLIA-waived for Influenza A & B and Strep A.

Alere infectious disease global president Avi Pelossof said: "Our innovative Alere i platform now allows for the rapid molecular detection of RSV, Influenza A & B and Strep A.

"The availability of clinically meaningful results in an actionable timeframe empowers clinicians to deliver prompt and appropriate patient care.”

In February, Healthcare firm Abbott agreed to acquire Alere for around $5.8bn.

The company provides tests in the areas of infectious disease, molecular, cardiometabolic and toxicology.