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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…
Test Kits Included in Class 1 Devices Exempt from 510k Filing
From - National Intelligence Report
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks that…
Screening Test Use Up After ACA
From - Diagnostic Testing & Emerging Technologies
There was an uptick in preventive screening after enactment of the Affordable Care Act (ACA), yet cancer-screening rates in the United States remain below…