Foundation Medicine launches innovative cancer diagnostic

Michael J. Pellini, CEO of Foundation Medicine

Less than two years after its debut, Foundation Medicine is hitting the commercial market with its first product. The FoundationOne molecular diagnostic test is a unique mix of genetic sequencing and data gathering designed to help oncologists pick the best treatment for individual patients.

Plenty of eyes will be watching closely to see if Foundation Medicine succeeds, in part because of the talent behind it. Scientists representing multiple disciplines at Harvard Medical School, the Massachusetts Institute of Technology, the Dana-Farber Cancer Institute and the Eli and Edythe L. Broad Institute launched the effort. Google Ventures, Third Rock Ventures and Kleiner Perkins Caufield & Byers funded the enterprise with $33.5 million in Series A financing.

The next-generation sequencing test also presents a potentially significant advance in the field of personalized medicine. At $5,800 per test, FoundationOne's technology can ferret out a large number of genetic alterations for 200 cancer-related genes, blending genomic sequencing, information and clinical practice. The idea is for doctors to use the CLIA-certified test to help guide cancer treatment decisions for patients with solid tumors. Once the company sequences the data, the oncologist gets genomic profile reports back for each individual patient, plus targeted treatment options and clinical trial information that could be helpful. That data is based on the latest scientific evidence as well as the specific gene alteration in a patient's tumor.

CEO Michael Pellini described the concept in a statement as "a convergence of genomic sequencing, information technology and clinical practice that would not have been possible at any other point in history" and claims that Foundation Medicine "is the first company with the ability to put these advances into everyday care."

The life sciences industry is already paying attention. Launched in 2010, the Cambridge, MA company has collaborative relationships in place with Celgene, Novartis, Sanofi, and J& J Pharmaceutical Research and Development, among others.

Of course, medical realities dictate that the test will need to win insurance coverage approvals to have traction.  A company spokesman told FierceMedicalDevices that Foundation Medicine is working  "with major academic institutions" on studies that will generate data needed to nail down third-party payor coverage. Additionally, the company has had initial discussions with both CMS and third-party payors.

- read the release

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