November 4, 2019 Intelligence: Late Breaking Lab News

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Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage to multi-gene testing for antipsychotic drugs. In writing about this decision, said, “UnitedHealthcare’s policy specifies that the use of pharmacogenetic multi-gene panels to guide therapy decisions is proven and medically necessary for antidepressants and antipsychotics medication when the following criteria are met: 1) The individual has a diagnosis of major depressive disorder or anxiety; 2) The individual has failed at least one prior medication to treat his or her condition; and, 3) The multi-gene panel has no more than 15 relevant genes.

MORE ON: PGx Testing

Meanwhile, as reported earlier this year by THE DARK REPORT, the Food and Drug Administration (FDA) has sent warning letters to a number of PGx testing lab companies advising them to review the compliance of their laboratory-developed tests (LDTs) with current federal regulations. The FDA’s actions directed at pharmacogenetic testing companies unsettled many clinical laboratory executives and generated criticism from several medical laboratory professionals.


In its third quarter earnings report, Neogenomics, Inc., of Fort Myers, Fla., reported revenue for third quarter increased by 51%, to $104.7 million. The company, which does molecular and genetic testing, also reported that revenue-per-test grew 15%, to $369. It also said that clinical test volume increased by 35% from Q3-2018 to Q3-2019.


  • Matthew Sause is the new President and CEO of Roche Diagnostics North America. He joined Roche in 2002 and held several executive positions. Most recently Sause was a Vice President at Genentech, a division of Roche Holdings, AG.
  • Anixa Biosciences of San Jose, Calif., appointed Thomas Schlumpberger, PhD, as its new Executive VP, Diagnostics. Previously, he held management positions at Inivata Limited, Singulex, Epocal, Affymetrix, and McKinsey & Company.

That’s all the insider intelligence for this report.
Look for the next briefing on Monday, November 25, 2019.

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…how a pathologist, a neurosurgeon, and a critical care phyisician in different cities have each been charged with manslaughter or murder following the deaths of patients they treated. These cases show that prosecutors are getting tougher with doctors who were negligent or who practiced while under the influence of drugs or alcohol.

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