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October 3, 2012
14:44 EDTALRAlere rallies after disclosing deal with FDA, updating revenue view
Alere (ALR) is surging after the company disclosed earlier today that it had reached a deal with the FDA on final release specifications for its Alere Triage meter-based products. The new specifications will further align the product release specifications to the package insert, and, as expected, represents a further tightening of the release specifications for Alere's Triage products, the company said. The company believes that the new specifications will result in lower manufacturing yields, but it continued to expand its manufacturing capacity to address the expected lower yield rate. Alere announced that revenue from its Alere Triage Cardiac Panel products in the U.S. were about $6M in the third quarter, in-line with its previous guidance of $4M-$8M. The company projects a supply shortfall for its Cardiac Panel products during October but expects to be able to meet demand for its cardiac panel in the U.S. from November onwards, it said. Alere estimates that its revenue from the panels in the U.S. will be about $6M-$8M in the fourth quarter. Revenues from sales of the TOX product line in the U.S. came in at $7M for the third quarter of 2012. Alere expects revenue of approximately $4M-$5M from U.S. sales of the product in the fourth quarter. In mid-afternoon trading, Alere rose $1.60, or 8.25%, to $20.99.
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