Earlier this month he co-authored a New England Journal of Medicine “Perspective” article summarizing the recommendations for biomarker tests, considered “the key to unlocking precision medicine.” These biomarker tests are very important as more and more tests become available to consumers, and both physicians and patients need to be sure the test they are taking is useful and of value specifically to them.
The 10 steps outlined in the NEJM article – drawn from the 229-page NASEM report – summarize how federal agencies, government and private payers, information-management organizations and software developers, professional organizations, accrediting agencies and others will need to work together.
Dr. Lyman says molecularly targeted therapies for cancer and other diseases are designed to counteract individual DNA quirks, such as genetic pathways that go awry and proteins that overexpress. Patients would be treated by therapies that specifically target the molecular underpinnings of their disease. But the process of testing for the quirks and designing the therapies is complex.
“You need good science to establish that a biomarker test is reliable, that the test is associated with the disease and an outcome of interest and, finally, that the treatment actually improves patient outcomes compared to standard treatment or usual care. Those three things – analytic validity, clinical validity and clinical utility – are what are needed before these tests should be permanently part of our care of patients on a routine basis,” Dr. Lyman says.
In their article, Dr. Lyman and Harold L. Moses, MD, of the Department of Cancer Biology at Vanderbilt University, said, “Biomarker tests for molecularly targeted therapies can help physicians to select the most effective therapy for a patient’s condition and avoid treatments that could be ineffective or harmful. If precision medicine is to reach its potential, such biomarker tests will have to be developed in a timely fashion.”
Here’s a link to an outstanding background piece on precision medicine that highlights a metastatic lung cancer patient who is directly benefiting from a targeted therapy designed to combat her ROS1 mutation. She, too, is available for interviews.
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