Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
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Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
Industry Newsmaker: Veracyte, Inc. Scores Big with Percepta and Affirma GEC
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Deal of the Month: $25 Billion Acquisition of St. Jude Med Cements Abbott as Leader in Cardiovascular Device Market
From - Laboratory Industry Report
In a month with an unusually heavy volume of diagnostic deal making, the headline story was Abbott Laboratories' $25 billion purchase of…
Arizona Fraud Suit Opens New Front in the Legal War against Theranos
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Update on Palmetto’s Molecular Dx Testing LCDs
From - Diagnostic Testing & Emerging Technologies
Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for…
New Laws: Civil Monetary Penalties Get More Expensive—and Easier to Dish Out
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Palmetto Latest Medicare Contractor to Loosen Up on Covering Molecular Dx Testing
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3 Things You Need to Know about the Lab Fee Schedule
From - Laboratory Industry Report
The Centers for Medicare and Medicaid Services (CMS) issued the final 2017 Clinical Laboratory Fee Schedule (CLFS) on Nov. 21. Here is a look at…
FDA Puts LDT Guidance on Ice
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So, Now What? How a Trump Presidency Will Impact Labs & the ACA
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LabCorp Acquires ClearPath Diagnostics
From - Laboratory Industry Report
Less than a month after its acquisition of neonatal specialty lab Sequenom, LabCorp acquired obstetric and gynecology testing firm…
