Life Technologies Corp. wants to stake a claim in the burgeoning personalized medicine space.
As cancer treatment becomes more and more tailored to patients’ DNA and the genetic makeup of tumors, Life is seeking to forge partnerships with pharmaceutical companies that need accurate tests to determine which patients will benefit from their targeted drugs.
The Carlsbad-based genetic analysis giant has hired Ronnie Andrews — former CEO of Clarient Inc., the Aliso Viejo-based cancer testing arm of GE Healthcare Co. — to serve as president of Medical Sciences, a new name for Life’s growing diagnostics business.
Andrews will report directly to Life Chairman and CEO Gregory Lucier, a spokesman said. His job is to refine Life’s business plan in the diagnostics and personalized medicine arena and bring new testing kits to market — particularly for cancer.
Conquering Cancers?
“The holy grail for cancer really lies in the unfolding knowledge of the human genome,” Andrews said. “I believe we’re standing at a major inflection point. The next five years in cancer will dwarf the last 50.”
Andrews predicts 40 to 60 new cancer drugs will enter the market during the next three to five years. And with each of those drugs, he estimates a so-called “companion diagnostic” market of $125 million to $200 million.
“It’s a couple billion dollars in the U.S. alone,” Andrews said. “That includes the test kit and the lab work to run the kit. You’re looking at a pretty sizable market.”
And it’s a market in which Life is poised well to compete, he said.
“Life’s platforms today are already deeply embedded” in laboratories around the world, he said. Plus, the company already makes a wide range of tests that run on the analysis equipment; those tests just haven’t been used thus far for clinical diagnoses.
Recent rulings by the U.S. Food and Drug Administration signal that companion diagnostics will play a more prominent role in the drug industry. Last July, the agency said that it will require pharmaceutical companies to submit their diagnostic tool for approval at the same time as the drug itself, with few exceptions.
“It is the agency’s goal to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The new rule is necessary because it’s becoming more common for drugs to depend on the use of a diagnostic test to meet their labeled safety and effectiveness claims, the FDA said.
“The future of medicine — and oncology treatment especially — is going toward personalized treatments,” said Hillary Theakston, executive director of The Clearity Foundation, a San Diego-based nonprofit that’s working to improve cancer outcomes through individualized treatment, starting with diagnostics.
Life has started to make inroads into that area. In October 2011, the company announced it had signed a deal with GlaxoSmithKline Biologicals S.A. to develop a molecular diagnostic test to be used with a potential lung cancer drug.
Life also received FDA clearance for its 7500 Fast Dx Real-Time PCR Instrument to be used with the U.S. Centers for Disease Control and Prevention’s swine flu test.
The company plans to submit its Ion Personal Genome Machine to the FDA in 2012. With the FDA’s clearance, any laboratory in the U.S. could use the machine for clinical diagnostic purposes — for example, to identify or decode DNA in a cancer tumor, a spokesman said.
“Life has multiple platforms that can be leveraged in the diagnostics market in the near term,” Andrews said. “It was the disruptive Ion Torrent technology, however, that tipped the scale for me to come on board.”
Life launched the Ion Personal Genome Machine in December 2010 as a DNA decoder with unprecedented speed, scalability and affordability. It’s the first gene sequencer that uses semiconductor technology.
A Proven Track Record
Andrews has served as CEO of Clarient since 2004, when the company was known as ChromaVision. He helped grow the company from $6 million in annual revenue to $120 million, and raised more than $50 million in capital to fund the company’s growth, Life said, in a statement.
During his time at Clarient, he launched new molecular tests for cancers, including leukemia and melanoma. GE Healthcare purchased Clarient in December of 2010 for $587 million.
Andrews also previously worked for Roche Holding AG, with management roles at Pleasanton-based Roche Molecular Diagnostics and with Indianapolis-based Roche Diagnostics Corp.
In a recent statement, Lucier called Andrews “one of the most dynamic and respected leaders in the diagnostic industry.”
