Alere announced FDA clearance of its Alere i Strep A test to detect Strep A bacteria in 8 minutes or less using throat swab specimens.
Alere 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.
Alere continued down the path of deleveraging and refocusing on its core competency in diagnostics with the sale of its Alere Health unit to Optum, a part of the insurance company UnitedHealth Group for $600 million.
Alere management is in advanced talks to sell its health management business, according to Reuters. In August, the diagnostics player had said it would do so before year-end as part of an ongoing strategic review aimed at returning the company to revenue and earnings growth.
Former Alere executives are putting together a $46-per-share takeover offer for the diagnostics company, according to a Sept. 15 SEC filing. Investors didn't embrace the offer entirely, but they did send shares up about 13% to $41.33 in midafternoon trading.
In the midst of a management transition, diagnostic company Alere missed its quarterly numbers. The company acknowledged its recent problems and missteps as well as started to outline a new strategic vision for Alere that will become clearer to investors around the end of this year, when a comprehensive review will be finished.
So much for those IPO plans. Alere last week decided against taking its BBI Diagnostics businesses public on the London Stock Exchange, citing equity market conditions in the U.K.
Alere's i Influenza A & B test, which the company says is the first and only molecular test to detect and differentiate beween the two types, received FDA clearance on June 16.
BBI Diagnostics Group provided details off its plans to be traded on the London Stock Exchange in June 2014 in a May 19 statement. The IPO will consist of the sale of the 25% indirect ownership interest in BBI held by parent company Alere.
In reaction to three patient deaths associated with its INRatio2 PT/INR Professional Test Strips, Alere initiated a voluntary Class I recall of the products.