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Alere Strep A Test Cleared by FDA; CLIA Waiver Submitted

NEW YORK (GenomeWeb) – Diagnostics manufacturer Alere announced today that it has received US Food and Drug Administration clearance for a group A Streptococcus test that runs on the firm's isothermal nucleic acid amplification platform, the Alere i.

The new test takes eight minutes or less to detect strep DNA in throat swab specimens, the company said in a statement. The firm also announced that is has submitted an application for CLIA waiver for the test.

Group A strep causes more than 10 million non-invasive infections per year in the US, according to the US Centers for Disease Control and Prevention.

The Alere i platform was previously FDA cleared and CLIA waived to run an influenza A/B assay, and was the first molecular system ever granted a waiver for use in low-complexity settings, such as physician offices and pharmacy clinics.

Given the less seasonal nature of strep A, the addition of the new test enhances the overall value of the platform for users on a year-round basis, the company said. The list price for the platform was previously reported to be $8,500.

Alere intends to further expand the menu on the Alere i platform to include tests for respiratory syncytial virus, C. difficile, and chlamydia/gonorrhea.These tests are on a timeline to launch throughout 2015 and 2016.

"The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency,” Avi Pelossof, global president of infectious disease at Alere, said in the statement.

The firm's other molecular platform, the Alere q, received CE marking for an HIV detection assay last month, and it is currently developing assays for Ebola, TB diagnosis, TB drug-resistance testing, and hepatitis C testing on that system.