“For a while people were not paying attention to this problem. It became much different when we began to use many of these assays as the sole determinants of treatment selection,” Dr. Wolff told Cancer Therapy Advisor

“The FDA is not late to the game. The FDA was fighting a lot of vested interests that were heavily lobbying against allowing it to exert its oversight regulatory influence. Fortunately, there is finally momentum towards the idea that we no longer can afford to have each lab do what each lab wants to do. The stakes are now much higher.”

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Dr. Wolff said the same attention must be paid to assay development as it is paid to drug development. He said, increasingly, drugs are being developed with a companion diagnostic test for patient selection.

“Patients and doctors as end-users realize that false-positive test results could lead many to be unnecessarily exposed to a potentially toxic and expensive placebo, while false-negative test results risk denying some patients access to effective and potentially life-saving therapies,” Dr. Wolff noted.

Jeffrey E. Shuren, MD, JD, who is the director for the Center for Devices and Radiological Health at the FDA, testified before Congress on September 11, 2014, and explained that the FDA is putting an emphasis on regulating high-risk LDTs.4

He said the FDA is stratifying LDTs based on risk, with greater requirements for medium-risk and high-risk LDTs. “We seek to assure that tests are safe and effective. The issue should not be do we regulate, but rather how should we regulate,” noted Dr. Shuren. “Patients deserve no less.” However, he said the FDA is trying to strike a balance so that innovation is not harmed.

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Dr. Shuren noted that part of the problem is that there is no surveillance program to find out when a problem does arise, so the FDA plans to set up a surveillance program. He said it is adopting a risk-based framework and it hopes to work closely with the laboratory community in order to achieve proper oversight without hindering innovation.

“It’s always important for oncologists to weigh in and talk together about regulatory changes that are going to impact their delivery of care to patients,” said Carl Morrison, MD, DVM, who is the clinical chief of the Department of Pathology & Laboratory Medicine and the executive director of the Center for Personalized Medicine at Roswell Park Cancer Institute in Buffalo, NY.

“The New York [Department of Health] has required basically the same demands from its test developers as the FDA is proposing. So these new [regulations] level the playing field among developers of diagnostic tests, and I think increased regulation and parity among manufacturers across the country is definitely in the best interests of patients.”


  1. Sawyers CL, van ‘t Veer LJ. Reliable and effective diagnostics are keys to accelerating personalized cancer medicine and transforming cancer care: a policy statement from the American Association for Cancer Research. Clin Cancer Res. 2014;20(19):4978-4981.
  2. Parkinson DR, McCormack RT, Keating SM, et al. Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer. Clin Cancer Res. 2014;20(6):1428-1444.
  3. U.S. Food and Drug Administration. Laboratory Developed Tests. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm407296.htm. Updated October 3, 2014. Accessed October 8, 2014.
  4. Energy and Commerce Committee: United States House of Representatives Chairman Fred Upton. 21st century cures: examining the regulation of laboratory developed tests. http://energycommerce.house.gov/hearing/21st-century-cures-examining-regulation-laboratory-developed-tests. Published September 9, 2014. Accessed October 8, 2014.