FDA Clears Life Technologies' OpTmizer™ T-Cell Growth Medium for Use in Clinical Trials
October 15, 2012
Carlsbad, Calif -- Life Technologies Corporation (NASDAQ: LIFE) today announced it has received FDA 510(k) clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium — a reagent that 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 OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium is intended for human ex vivo (outside the body) tissue and cell culture processing application. This means it is designed to efficiently grow large numbers of potentially therapeutic T-cells, which have demonstrated promise in clinical studies as an effective treatment for diseases including cancer, infectious diseases such as AIDS, and autoimmune disorders.
"We are very pleased to learn of Life Technologies' successful outcome in achieving its FDA 510(k) regulatory clearance for its OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium, and we value the close working relationship we have established with Life Tech," said Neil K. Warma, President & CEO of Opexa Therapeutics, Inc. "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."
As a product that is manufactured following GMP requirements in an ISO 9001/13485 certified facility, 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. The ability to document manufacturing process details, quality control testing and component traceability streamlines the review process when submitting Investigational New Drug (IND) applications to the FDA as required for clinical trial initiation. Its effectiveness in rapid T-cell expansion at high cell density can reduce media usage, which results in end-user cost savings.
OpTmizer™ CTS™ T-Cell Expansion Tissue Culture Medium is currently being used in multiple clinical trials in the United States. It complements other Life Technologies Cell Therapy Systems (CTS™) branded products that have previously received 510(k) clearance by the FDA. They include: AIM V® Medium, DMEM, KnockOut™ SR Medium, KnockOut™ SR XenoFree Medium and StemPro MSC SFM CTS. The company's portfolio of solutions addresses a wide range of cell types and procedures including the isolation, expansion, differentiation and characterization of cells.
"The availability of validated tools for use in clinical trials is one of the key steps to realizing the potential for stem cell therapy," said Chris Armstrong, Ph.D, General Manager and Vice President of Primary and Stem Cell Systems at Life Technologies. "The FDA's clearance of our product for culturing T-cells is an important step in that direction and supports our commitment to offering our customers leading products that drive their translational research."
In 2010, Myriad Genetics brought in $353 million (88 percent of their total revenue) from the breast cancer test. However, the industry has not seen any new innovation from Myriad in the past five years, when it last introduced the most recent BRCA1/2 test. Executives at Myriad say they
plan to prepare for technological improvements, in response to claims of newer DNA-sequencing techniques being faster and less expensive compared to the technology that Myriad uses, reportedly from the 1990s.
Admittedly, former Myriad employee Sean Tavtigian said that the company “is trying to catch up, but it’s going kind of slow.” In fact, Life Technologies has developed a new Proton Sequencer that
can read an entire person’s genome for $1,000 - less than Myriad charges for just two genes. A British company, Oxford Nanopore, has followed suit and recently introduced the world’s first miniature DNA sequencer and will be possibly available commercially this year for $900. But because of strict patent protection on BRCA1/2, lawyers remain unsure whether other methods, like full gene sequencing, would violate Myriad’s patents on the isolated genes. Some predict that when Myriad’s patents expire, the price of whole genome sequencing will trend as low as $100, and single-gene test methods will be moot.
In other words, the exact concerns raised by the Supreme Court in Prometheus directly support the ACLU in its fight against Myriad. The Court argued that Prometheus’ blood test patent directs a treating physician towards a particular course of action, imposing on the sanctity of the doctor- patient relationship. Explicitly the Court recognizes that these patents “tie up the doctor’s subsequent treatment” and “threaten to inhibit the development of more refined treatment recommendations.” Further, Prometheus’ patent encourages physicians to discard crucial treatment factors such as individual patient characteristics and physician’s own medical inferences in favor of a metabolic blood test. In the world of patent eligibility, Prometheus forces applicants and courts to reconsider the law of nature prohibition, as opposed to the equally controversial novelty, and non-obviousness requirements.
Doomed?? Management told us ILMN was worth much more than Roche had offered and that they would deliver that value to shareholders if only we would turn down Roche and let them keep their job. And so they did keep their jobs -- but not their promise (so far).