Brief Your CEO: New Penalties Double the Dollar Value of Protecting Your Lab from Liability

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April 24, 2018  
placeholder  LEGISLATION
Brief Your CEO: New Penalties Double the Dollar Value of Protecting Your Lab from Liability
From - G2 Compliance Advisor
You may not realize this, but Congress has just doubled the dollar value of what you do as a compliance manager to keep your…
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placeholder  ENFORCEMENT
Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From - National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
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placeholder  NEW PRODUCTS
FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
From - Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
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placeholder  EMERGING TESTS
SIDs Results From Genetic Heart Disease Less Than Previously Thought
From - Diagnostic Testing & Emerging Technologies
The vast majority of sudden infant death syndrome (SIDS) cases are not the result of genetic heart diseases (GHDs) or a single genetic cause…
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