Alere snags first FDA CLIA waiver for molecular influenza test

The Alere i Influenza A & B test--Courtesy of Alere

Alere ($ALR) won an FDA CLIA waiver for its molecular influenza test, giving the company a boost amid restructuring efforts and putting its diagnostic in the hands of more healthcare professionals as flu season reaches epidemic status.

The Waltham, MA-based company's Alere i Influenza A & B test is the only molecular diagnostic that can detect and distinguish between influenza A and B virus in less than 15 minutes using a nasal swab, and is the first nucleic acid-based test to receive the agency's CLIA (Clinical Laboratory Improvement Amendments) waiver. The CLIA waiver allows the test to be used in additional healthcare settings, including hospitals, physician offices and clinics, Alere said in a statement.

"By making lab-accurate, actionable results available at the point of care, Alere i empowers healthcare providers to quickly identify and treat people with influenza--improving patients' clinical outcomes, protecting their communities, and reducing healthcare costs," Avi Pelossof, Alere's global president of infectious disease, said in a statement.

Regulators granted Alere a CLIA waiver based on promising study results which showed the test's effectiveness in identifying the flu and low risk of false results when used by untrained operators. The company won an FDA OK in June for its Alere i influenza A & B test as a prescription-only device, classifying the diagnostic tool as moderately complex and therefore not appropriate for wider use.

The waiver allows Alere to cash in on a profitable market, as more than 200,000 people in the U.S. are hospitalized with flu-related complications each year, according to the CDC. An FDA blessing for its molecular influenza test also helps Alere generate some momentum at a pivotal moment, as the company struggles to find its footing after the recent divestiture of its Health unit and generate growth after deciding against an IPO for its diagnostics business.

Alere's former CEO, Ron Zwanziger

In June, the company announced that it would not take its BBI Diagnostics business public due to poor equity conditions in the U.K. Alere did not disclose any details about its change of heart but said that it planned to look for greater value for the unit.

In October, Alere sold its healthcare unit to Optum for $600 million in an effort to reduce its expenses and pay down debt. The company said at the time that it planned to put more unprofitable businesses up for sale, citing interest in its healthcare analytics unit.

Meanwhile, Alere continues to ward off a $3.8 billion take-private offer assembled by former executives who left the company in June, including ex-CEO Ron Zwanziger. Zwanziger, along with two other past execs, concluded that that transaction was financeable at a price of $46 per share or higher, depending on the results of due diligence.

- read Alere's statement (PDF)
- get more from the FDA
- here's Reuters' take