A Boom in Clinical Genomics Services

Companies are recognizing a market opportunity in the need to deliver useful genetic analyses for cancer treatment to physicians, and they're rushing to meet the demand.

A year-old collaboration among business information giant Thomson Reuters, of New York; pathology service provider PathGroup, of Nashville, TN; and software developer GenoSpace, of Cambridge, MA, will provide genetic analyses for patients for the first time later this year. Molecular information firm Foundation Medicine, also of Cambridge, is expected to raise more than $85 million when it goes public in coming weeks. Other startups are jumping into the field, while established test providers expand their services. Additionally, medical centers across the country are getting into the game themselves, offering their own assays to aid their patients and keep them in-house.

Figuring out how genetic information can inform treatment decisions isn't straightforward, and it isn't possible for physicians to memorize what actions to take with which gene variants, says Mia Levy, MD, PhD, an assistant professor of cancer research and director of Cancer Clinical Informatics at Vanderbilt University in Nashville, TN, which runs its own service called MyCancerGenome. “The science is growing at such a rapid pace that you just can't keep up with the knowledge that's out there.”

“I think there's a lot of noise happening now,” says Chris Cournoyer, CEO of N-of-One Therapeutics, of Waltham, MA, which provides analytics for Foundation Medicine among other firms. Among N-of-One's clients' patients, more than one third received a new treatment or approach after their oncologists saw the analytics, Cournoyer says. The clinical interpretation adds less than 10% to the cost of genetic assays, Cournoyer adds, estimating that the tests range in cost from about $2,000 to more than $7,000.

However, government-funded plans and the insurance industry haven't decided whether to routinely cover the genetic sequencing and interpretation, Cournoyer says. “We don't have clear insight right now into when the reimbursement challenge will be solved.”

Keeping up with the science will also be a challenge for analytics companies, says John Quackenbush, PhD, GenoSpace chief executive and professor of computational biology and bioinformatics at Harvard School of Public Health in Boston, MA. That's why his company partnered with Thomson Reuters and PathGroup, he says. The trio will provide physicians with detailed, individual web pages for each patient, combining molecular diagnostics with other patient data in an effort to provide the best analysis and treatment options.

“Right now, personalized genomic medicine is almost like the Wild West,” Quackenbush remarks. “Lots of different people are trying to figure out what the right strategy is. There's clearly a market opportunity but there's also really an important opportunity to try to advance the way medicine is practiced.”