AMedicare advisory panel in May expressed little support for two types of genetic testing—those to determine cancer of unknown primary site (CUP) with metastatic tumors and those to identify patients at higher risk of cervical cancer. The vote of low confidence, experts say, has to do more with the lack of evidence demonstrating impact on clinical outcomes than the validity of the tests. Test developers throughout the diagnostics industry need to work to plug this evidence gap in order gain recognition by professional societies in clinical practice guidelines and by payers with reimbursement and coverage. “This [process] basically establishes what evidence exists behind a test and shows there is a big hole in clinical utility. Does having information from this test make patient outcomes better? No one made that leap,” says Diane Allingham-Hawkins, Ph.D., senior director, genetic test evaluation program at the consulting firm Hayes (Lansdale, Pa.). “Evidence is very much at the front and center of the discussion right now. There is awareness that this is the barometer tests will be judged by and companies must realize that. . . . Given the fact that organizations like CMS now know what they are being asked to pay for, there […]