Alere Inc. (ALR) Reaches Deal With FDA on Manufacture of Blood Test
10/4/2012 8:25:17 AM
Alere Inc said it reached an agreement with U.S. health regulators on product specifications related to the manufacture of its diagnostic test for critical disease. The company's shares were up about 9 percent at $21.09 on Wednesday on the New York Stock Exchange. Prior to Wednesday's gains, the stock had lost about 12 percent of it value since March, when the U.S. Food and Drug Administration began an inspection of the company's San Diego facility questioning the labeling and quality control of its Triage products. While the agreement with the FDA will lead to lower manufacturing yields of the Triage products, the company will raise production to 3.3 million tests per month to meet demand, Alere said in a regulatory filing on Wednesday.