Oct 3 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
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
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.
"This represents closure on long process on discussions with
the FDA and makes for a much clearer path for Triage business
going forward," Wedbush Securities analyst Zarak Khurshid said.
The company had to recall several lots of its Triage
products in May as they did not meet the interim specifications
set by the regulator.
Alere expects a shortfall in supply of the products due to
the lower yields for October, but expects to be able to meet
demand from November.
Alere's Triage is a test system that helps in the diagnosis
of critical diseases and health conditions including heart
failure and heart attacks.