Alere strikes deal with FDA on Dx manufacturing

Diagnostics company Alere ($ALR) says it has reached an agreement with the FDA over production of its Triage cardiac tests, after recalling thousands of the kits in May over quality control concerns.

In an 8-K, Alere says it has addressed the FDA's warnings and amended its manufacturing process. That'll bring down yields for Triage, but Alere plans to boost production to meet demand, churning out 3.3 million units a month instead of the previously announced 2.7 million.

The earlier production hiccup will mean a short-term shortfall in supply, however, and Alere is now projecting fourth-quarter Triage revenue to come in between $6 million and $8 million, below the up to $12 million the company initially forecasted.

As Reuters reports, Alere's stock was up about 9% on the announcement that it had made peace with the FDA. Prior to that, the company had lost about 12% of its value since March when the FDA debacle began.

Though now resolved, the Triage recall certainly dealt a blow to Alere's profitability. In the last quarter, the company reported an $18.2 million loss--quadruple that of the same quarter in the previous year--due in large part to a reported $82 million in one-time charges that included the costs of the recall.

Aside from those charges, however, Alere had a huge revenue quarter, as its professional diagnostics unit rose 33% to $538 million and its diabetes business brought in $36.8 million.

- read Alere's 8-K
- get more from Reuters

Like what you're reading?
Click here to get more news like this delivered to your inbox every day >