Assessing the Clinical Utility of Companion Diagnostics - Episode 1

Use of Molecular Tests That Assess Risk of Recurrence

In the first segment of this one-on-one interview series, John L. Fox, MD, MHA, senior medical director and associate vice president of medical affairs at Priority Health, discusses the use of molecular tests that assess the risk of cancer recurrence.

Several currently available molecular tests predict the risk of recurrence in early-stage breast cancer. Peter Salgo, MD, asks Dr Fox whether there is an advantage to a decentralized test versus a centralized test. Dr Fox explains that although decentralized tests offer more rapid turnaround times, there is no advantage to the patient or the payer, as patients do not begin treatment immediately. If 2 tests, 1 decentralized and 1 centralized, are equally beneficial and comparably priced, Dr Fox comments, he is indifferent as to which is utilized.

Dr Fox notes that professionals currently rely on the accuracy and transparency of information provided by the manufacturer of a test. He is hopeful, however, that more stringent evaluations of laboratory-developed tests and FDA oversight of companion diagnostics will help ensure the clinical and analytic validity of approved tests.

Watch our related Peer Exchange, Oncology Stakeholder Summit 2014: Evidence-Based Decisions to Improve Quality and Regulate Costs