Pioneering genetic-testing company Myriad Genetics sells a test called GeneSight that claims to analyze a patient’s DNA and point them to the best depression drug for them.
Scientists and doctors have raised concerns about GeneSight and other similar tests. Now, the FDA is asking for changes to GeneSight, Myriad Genetics disclosed on Tuesday.
Those changes “could significantly limit” broad adoption of GeneSight because it would not be able to make specific drug recommendations, JPMorgan analyst Tycho Peterson and team said.
This news comes after UnitedHealth Group, the nation’s largest health insurer, said it would start covering GeneSight and other such tests for certain patients starting in October.
Myriad Genetics stock dropped nearly 40% in Wednesday morning trade.
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Genetic-testing company Myriad Genetics’s biggest up-and-coming product is a test that claims to match patients with depression to the best medications for them, based on their DNA.
The test, GeneSight, and ones like it have been criticized by scientists and doctors, who’ve raised questions about how useful they are to patients.
Now, the US Food and Drug Administration is asking for changes to the GeneSight test, Myriad disclosed late Tuesday in a regulatory filing. The company didn’t provide much detail on what changes may be required.
“The FDA requested changes to the GeneSight test offering, and we have been in ongoing discussions with the FDA regarding its request,” Myriad said in an annual report filed with the US Securities and Exchange Commission. “Although we continue to disagree that changes to the test are required, on August 10, 2019 we submitted a proposal regarding the reporting of GeneSight test results to healthcare providers that we believe addresses the FDA’s principal concerns.”
CFO and EVP R. Bryan Riggsbee added on Tuesday that the approach Myriad is taking here “should not affect the benefits that we believe are provided by the GeneSight test.” Riggsbee made the remarks as part of a conference call discussing the company’s fourth-quarter financial results.
Read more: Pioneering genetic-testing company Myriad’s biggest up-and-coming product could be at risk after scientists raised major questions
When pressed by Wall Street analysts for more details on the call, company executives declined to comment any further.
‘A meaningful risk to the long-term potential of GeneSight’
The regulator’s request could prevent Myriad from making specific drug recommendations in its reports, JPMorgan analyst Tycho Peterson and team said.
This “could significantly limit the broader adoption of GeneSight” JPMorgan’s Peterson and team said, adding that “we view this development as a meaningful risk to the long-term potential of GeneSight.”
Myriad shares dropped nearly 40% in Wednesday morning trade, to $27.42 a share. JPMorgan rates Myriad “underweight” and has a price target of $27 per share for the company. Myriad shares closed at $44.55 on Tuesday.
A $2,000 test for depression drugs like Zoloft and Paxil
GeneSight, which costs about $2,000, works like this: First, a patient gets a cheek swab taken. Later, a report comes back, breaking down various depression drugs like Zoloft and Paxil into different, color-coded …read more
Source:: Business Insider