MolecularHealth Enters the American Cancer Genomics Market

By Aaron Krol

October 11, 2013 | Cancer care is growing more particularized as the disease becomes better understood. The national burden of cancer is enormous – with more than a million and a half new cases diagnosed every year – but that figure obscures a highly heterogeneous set of conditions as distinct from one another as the people they afflict. The unique genetics of each case present a moving target for oncologists and molecular pathologists. “Anyone in this field knows that the whole genomic aspect of cancer is rapidly developing,” Dr. Lloyd Everson, a former vice chairman of U.S. Oncology with four decades’ experience in cancer care, told Bio-IT World. “It is the future of medicine.”

Dr. Everson is part of a team of four specialists who left U.S. Oncology in September to join the management team of MolecularHealth’s new North American branch in The Woodlands, Texas. MolecularHealth, founded in 2004 and based in Heidelberg, Germany, is preparing to launch a personalized, direct-to-consumer genomic service for cancer patients, sequencing the whole exomes of their tumors and recommending treatment based on the best available research. As CEO of the company’s U.S. branch, Dr. Everson is charged with putting this ambitious diagnostic program into practice in the world’s largest market.

Genomic cancer diagnostics is a multi-tiered enterprise. First, a representative sample must be extracted and sequenced – already a complex task due to the amount of genetic variety that may be present even in a single tumor. Still, rapid progress in lowering the timeframe and cost of sequencing makes this step far more practicable than it would have been just a few years ago. Depending on the genetic panel desired, Dr. Everson expects MolecularHealth to turn around samples in as little as 12 hours. “There’s been a lot of activity, a lot of research and development, in the actual gene sequencing environment,” he says. “But where the real opportunity and challenge lies is in the bioinformatics area of putting this information to use for the patient.”

That’s the second step: analyzing all the data generated and mining it for expected outcomes, treatment responses and drug associations. Despite extensive research on cancer genetics, a large amount of subjective judgment remains in deciding which information is actionable, and what the best course of treatment for a cancer with a given profile should be. This is perhaps the greatest opportunity for a cancer diagnostics company to distinguish itself from competitors, by creating a track record of effective recommendations, uncovering treatment options that physicians might not have found on their own – and acting responsibly in determining when an obscure study offers a viable course of action. “When you do a whole exome on [cancerous cells],” says Dr. Everson, “you find a lot of things that aren’t necessarily actionable in the current sense of the term, but do find associations in preclinical, Phase I and other studies with drugs that may indeed be very targeted to those gene variations. It’s a moving field.” Keeping pace with that field will demand constant reevaluation of MolecularHealth’s metrics for tying variants to treatments, as well as a tumor DNA bank so that results can be reinterpreted in the light of new research.

Of course, the best information in the world won’t help patients and their physicians fight cancer if it isn’t formatted in a useable way. The third piece of the diagnostic pipeline is delivering the right results to the right end users. MolecularHealth is developing three separate modules for reporting results: a detailed report for molecular pathologists that includes both findings and test procedures; a one-page summary for oncologists with access to the relevant research; and a tool for the patients themselves. This last represents a delicate balance of good customer service and responsible medicine. “We want to make sure that if and when our patients access their own material, they have an educational environment that explains what this all means,” says Dr. Everson.

If MolecularHealth is successful, the company will be generating a huge database of genetic cancer profiles. That information could be of invaluable use to research partners like the MD Anderson Center, with whom the company intends to share its data on genetic variants, treatments and outcomes. MolecularHealth also has an exclusive partnership with the FDA to exchange information on adverse drug responses, integrating the FDA’s existing Adverse Event Reporting System with the company’s more detailed molecular analysis of drug interactions in the body. The resulting tool, called the Molecular Analysis of Side Effect information (MASE), will help alert MolecularHealth when an otherwise recommended pharmaceutical course could be expected to trigger an adverse response, adding another layer of personalization to the company’s service. MASE will also provide targets for future research on the molecular pathways that trigger side effects. “This is an absolutely unique tool,” Dr. Everson says, which will help MolecularHealth stand out when cancer patients and their families search for healthcare solutions.

MolecularHealth is currently seeking CLIA certification for its laboratory in Texas, and hopes to launch commercial services in the first quarter of 2014. Although integrated genomic cancer diagnostics is an emerging discipline, the company will already be entering a crowded field, with a competitor, Foundation Medicine, staging a successful IPO this September. Both companies have the backing of major players in the commercial IT field: MolecularHealth is supported by Dietmar Hopp, a co-founder of SAP, while Google and Bill Gates are both major investors in Foundation Medicine.

These are “visionary people,” says Dr. Everson, looking for ways “to push the envelope and make these kinds of advances accessible to real patients in real time.” With whole genome sequencing cheaper and easier than ever, and analytic software catching up to the volume of data involved in genomics, it seems a tipping point has been reached in cancer care, when long-awaited diagnostic tools can finally reach the patients who need them.