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Alere Gets CLIA Waiver for Strep A MDx; Announces Business Transactions

A previous version of this article incorrectly stated that Roche's Liat platform is based on isothermal amplification. It is a real-time PCR system.

NEW YORK (GenomeWeb) – Alere's rapid molecular diagnostic for the DNA of Group A Streptococcus has received CLIA waiver from the US Food and Drug Administration, the company announced today.

Separately today, the firm also announced a divestiture and acquisition intended to "strengthen the company's focus on its core business strategy," which it has recently described as more focused on molecular testing.

The eight-minute Strep A assay is the second that has been CLIA waived for the firm's Alere i platform, enabling tests to be run in low-complexity healthcare settings such as "physician offices, hospital emergency rooms, and retail and walk-in clinics" in the US, the company said in a statement. 

“Strep A is highly transmissible, and prompt treatment is critical to reducing the spread of the infection to others," Avi Pelossof, global president of infectious disease at Alere said in a statement. "With CLIA waiver for the Alere i Strep A test, we can help link more people to early treatment by bringing rapid molecular diagnosis to even more settings where they seek health care.”  

The Alere Strep A test was cleared by the FDA in April. A 15-minute assay for this infectious disease on the Roche cobas Liat real-time PCR platform was CLIA waived in May, and both firms are populating their rapid MDx systems with infectious disease menus, as previously reported.

Other assays in development for the Alere i include ones for respiratory syncytial virus, Clostridium difficile, and chlamydia/gonorrhea, and the company is planning to commercialize another platform, the Alere q, in non-US markets soon.

Meantime, Alere said today that earlier this month it divested its BBI business to a UK-based firm, Exponent Private Equity, for approximately $164 million. It also acquired Huntsville, Alabama-based US Diagnostics, a provider of drug testing devices and a current distributor of Alere toxicology products, for $60 million.

Alere said it expects the two business transactions to be dilutive to earnings per share by approximately $0.00 to $0.05 in 2015.