Business & Tech

FDA approves Foundation Medicine’s cancer gene test

Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine Inc.
Jon Chomitz
Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine Inc.

Federal regulators Thursday approved a diagnostic test by Cambridge-based Foundation Medicine Inc. that company leaders say will enable them to sequence the DNA of different cancer tumors to tailor treatments.

The Food and Drug Administration approved the test, called FoundationOne CDx, which can detect all four classes of alterations in 324 cancer-related genes that cause solid tumors. That includes those found in the lung, colon, breasts, ovaries, and — in cases of melanoma — skin.

In addition, the Centers for Medicare & Medicaid Services, has recommended that Medicare pick up the cost of the test — probably several thousand dollars for each patient — for many Americans with cancer.

Advertisement

FDA Commissioner Dr. Scott Gottlieb said the dual actions reflect a government effort to “bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs.”

Jonathan Saltzman can be reached at jsaltzman@globe.com.