Alere gets FDA 510(k) clearance for Alere i RSV Rapid Molecular Test

21 August 2016 (Last Updated August 21st, 2016 18:30)

Global diagnostic device and service provider Alere has secured the US Food and Drug Administration 510(k) marketing approval for its Alere i RSV Rapid Molecular Test to detect respiratory syncytial virus (RSV) in children and adults.

Global diagnostic device and service provider Alere has secured the US Food and Drug Administration 510(k) marketing approval for its Alere i RSV Rapid Molecular Test to detect respiratory syncytial virus (RSV) in children and adults.

Alere i RSV is the latest development on the Alere i platform following the Alere i Influenza A & B and Alere i Strep A tests.

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."

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

“We are excited to continue our ground-breaking innovation on this platform with multiple new analytes progressing well through product development."

The molecular test can be used to detect RSV nasopharyngeal within 13 minutes or less by examining swab samples using Alere’s patented Molecular in Minutes isothermal nucleic acid amplification technology (iNAT).

In acute care settings, the simple to use point-of-care RSV test offers speed and molecular accuracy to promote early and appropriate supportive care in order to avoid unnecessary antibiotic treatment.

An early initiation of infection control measures aids in controlling the spread of the highly contagious and malignant virus.

The company is planning to apply for Clinical Laboratory Improvement Amendments (CLIA) waiver of the Alere i RSV test.