Joseph Burns

11Few weeks go by without someone touting the benefits of a new genetic test. Such innovation is needed, of course, except when it overwhelms our ability to vet these developments. Yet that’s already happened. Health plans can’t keep up with orders from physicians for new complex molecular diagnostic tests that clinical labs develop and promote as the next best technology to improve patient care. Early this year, Aetna, Anthem, and Cigna said that they were not paying for multigene panels because the tests have yet to show sufficient clinical utility. Ordering such tests leads patients to get more tests and more care they may not need, the insurers argued. Not surprisingly, the clinical labs marketing these tests charged insurers were endangering patients by refusing coverage.

“We’re in a transitional period because new technology, like next-generation sequencing, is driving down testing costs,” says Gary W. Procop, MD, a medical director at the Cleveland Clinic.

Arguments on both sides of this debate will become more heated in 2016 given that worldwide demand for molecular diagnostic tests is expected to grow from an estimated $4.3 billion in 2012 to $8.7 billion by 2019, according to a report from Transparency Market Research.

So who’s right? Gary W. Procop, MD, a medical director at the Cleveland Clinic, runs a highly regarded diagnostic test utilization management program. Not all tests have clinical utility, but those that do are quite useful to patients and physicians, he says. While clinical labs have made a lot of money marketing multigene panels to physicians, it’s possible to get most of the answers a physician needs from one, two, or three tests and not the 20 or more bundled in multigene panels, he explains.

“We’re in a transitional period because new technology, like next generation sequencing, is driving down testing costs. With NGS, you may be able to get 20 answers for the price of one. As costs come down, it changes the paradigm,” Procop says.