Issue: Volume XXIV No. 12 - August 28, 2017

Big Payers Want to Bring Order to Genetic Testing

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 …

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50,000 Patients to Retest After Invitae Finds Errors

CEO SUMMARY: In recent weeks, a client notified Invitae of discordant results on a patient. The notification caused the genetic testing company to discover it had a systemic error that failed to test for a specific rare mutation associated with inherited cancer. Company officials believe only 2 to 15 patients received a false negative test …

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Estimating Total Costs When Genetic Tests Must Be Retested

INVITAE, A GENETIC TESTING COMPANY IN San Francisco, has begun a retest program involving 50,000 patients. Such a large retest effort is without precedent in the still-nascent genetic testing marketplace. Clinical laboratories and genetic testing companies commonly find that, in daily operations, a batch of samples produced unreliable or inaccurate results. These discoveries are made …

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Invitae Investing Heavily To Expand Market Share

CEO SUMMARY: In its first five years of offering clinical tests, Invitae has outspent revenue by $330.7 million. Yet its executives are confident that their company is on a path to becoming one of the dominant players in the genetic testing sector. This profile of Invitae will help pathologists and lab administrators understand more about …

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Two Largest Payers Start Lab Test Pre-Authorization

CEO SUMMARY: Once Anthem and UnitedHealthcare establish their respective genetic test prior-authorization programs, a new era for genetic testing will commence. The 80 million beneficiaries served by these two payers make up half of the individuals who have private health insurance. It is reasonable to expect that other health insurers will follow the lead of …

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UnitedHealth to Start Gene Test Pre-Approval

CEO SUMMARY: With programs now at the nation’s two largest insurers, is it possible to argue that prior-authorization is going mainstream? Some observers say, yes, as THE DARK REPORT predicted. What is certain is that starting Nov. 1, UnitedHealthcare is requiring prior authorization for genetic and molecular tests for its fully-insured commercial members nationwide. That …

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Anthem/AIM Responds to Queries About Its Pre-Approval Program

AFTER SEVERAL LABS SPOKE about the difficulties in working with the new Anthem/AIM Specialty Heath prior-authorization program for genetic tests, THE DARK REPORT sent questions to Anthem. Responses from Anthem/AIM were lengthy and have been edited to fit the available space: Q: Is it true that labs cannot assist physicians in ordering tests through the Anthem/AIM …

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Labs Report Problems with Anthem’s Pre-Approval

CEO SUMMARY: Since the July 1 launch of its prior-authorization program for genetic tests, Anthem and its subsidiary, AIM Specialty Health, have authorized few genetic tests, said a national lab. Lab directors say they have been unable to communicate with Anthem/AIM when client physicians order tests. Also, labs are unaware if Anthem has trained ordering …

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August 28, 2017 Intelligence: Late Breaking Lab News

Genetic testing for dogs is the goal of Embark Veterinary, of Boston, Mass. Founded in 2015, the company just raised $4.5 million from investors, including Anne Wojcicki, founder of 23andMe. Company executives say the genetic testing will help vets, pet owners, and breeders identify the disease risk of the dogs, as well as the animals’ …

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