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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
OIG and DOJ Offer Tips for Evaluating Compliance Effectiveness
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23andMe Gains FDA Approval for DTC Test
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Dx Jobs Market: Survey Highlights Importance of Soft Skills in Hiring of New Pathologists
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8 Traps to Avoid When Investigating a Sexual Harassment Complaint
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Liability Traps to Avoid:
Commission-Based Lab Marketing Arrangements
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Theranos Settles with CMS and Arizona Attorney General
From - National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
Key Players in Blood-Based Concussion Testing Market
From - Laboratory Industry Report
There is a great need for better tools to diagnose concussion. Currently, there is no single marker or panel of markers in widespread clinical use and diagnosis remains based on clinical…
Watch Out for Resume Fraud
By Lynne Curry, Ph.D bio
You know that new laboratory assistant you just hired—the one with the terrific resume and reference? It turns out she never worked for the employers named on the resume or…
Genomic Markers May ID Risk of Chemo Side Effects
From - Diagnostic Testing & Emerging Technologies
While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to…
Abbott and Alere Reach New Deal Terms
From - Laboratory Industry Report
Abbott's deal to acquire Alere is back on. Both companies announced Friday, April 14, 2017, that they will move forward with the deal and have revised its terms…