(By Balachander) Life Technologies Corp. (NASDAQ:LIFE) said U.S. health regulators have cleared its product that is intended for human ex vivo tissue and cell culture processing application.
The company received 510(k) regulatory approval from the U.S. Food and Drug Administration for its OpTmizer T-Cell Growth Medium that is currently being used in multiple clinical trials in the United States.
The product, a reagent, is now cleared as a Class II medical device and offers cost-and time-saving advantages for transitioning studies from the research bench to clinical trials, the Carlsbad, California-based company said.
"The receipt of 510(k) status for OpTmizer CTS T-cell expansion media simplifies the regulatory path for Opexa as we continue the development of Tcelna, a T-cell immunotherapy for the treatment of patients with multiple sclerosis," said Neil Warma, CEO of Opexa Therapeutics Inc (NASDAQ:OPXA).
According to Life Technologies, OpTmizer CTS T-Cell Expansion Tissue Culture Medium provides a xenofree formulation, containing defined components that can help reduce variability during the development of T-cell therapies. Its effectiveness in rapid T-cell expansion at high cell density can reduce media usage, which results in end-user cost savings.
Opexa develops cellular therapies based on its proprietary T-cell technology.
LIFE shares, which have been trading in the 52-week range of $36.07 to $50.84, added 0.16 percent to trade at $48.64 on Thursday.