IMPORTANT CHANGES ARE POISED TO TRANSFORM genetic testing. As this happens, there will be a new crop of winners and losers among genetic testing labs.
Recent events can be interpreted as favoring two trends that most genetic testing companies consider as unfavorable to their interests. One trend is adoption of genetic test prior-authorization programs by health insurers both large and small. The second trend is increased federal oversight of genetic testing. This entire issue of THE DARK REPORT is devoted to the unfolding events in recent weeks that involve both trends.
Our lead story is about the systemic error in genetic tests performed by Invitae Corporation and it was THE DARK REPORT which first reported this development. Clinical pathologists who are medical directors will recognize the significance of this episode. When Invitae revised its genetic tests, it omitted the material for a rare mutation associated with inherited cancers. It then performed genetic tests from September 2016 through 2017 and, during this time, its quality control program never detected this error.
Only in July, after a clinician notified Invitae about discordant results reported by two labs, did Invitae investigate and uncover this error. In response, the company is quick to point out that it estimates only 2 to 15 patients had false negative test results for the omitted mutation. But, as part of its root cause analysis, Invitae will contact physicians and retest 50,000 patients. Clinical pathologists understand all the implications in these events and federal and state regulators are sure to react to these developments, possibly using this episode to argue in favor of FDA regulation of laboratory-developed tests.
The other news story is that Anthem and UnitedHealthcare—the nation’s two largest health insurers—are initiating genetic test prior-authorization programs within months of each other. But that’s not all the bad news. THE DARK REPORT has interviewed two major genetic testing labs about the difficulties they are having obtaining prior-authorization for their physicians ordering genetic tests. The second interview is presented in this issue.
Might there be irony in the fact that the two big developments in recent months involve making it tougher for labs to get paid for genetic tests and giving lab regulators a systemic lab failure that can be used to justify tougher oversight of genetic testing labs?