Dx Deals: Outreach Deals by Quest, Labcorp Are Still Ramping Up
Though the two national players have closed dozens of such deals over the past decade, much runway for new transactions apparently remains
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Articles and Reports
Electronic Device Use in the Laboratory: The Keys to Safety
Three main risks to consider when it comes to personal electronic devices, and how to safely incorporate their use in the laboratory
Considering the Impact of Digital Pathology on Recruitment Efforts
How might a modestly sized lab or pathology group harness technology to address their recruitment needs?
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…
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…
Avoid Liability for Commission-Based Marketing Arrangements
From - G2 Compliance Advisor
Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on…
FDA Grants Approval for 23andMe DTC Genetic Test
From - National Intelligence Report
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for…
Making Laboratory Safety as Simple as ABC
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When it comes to safety in the laboratory, there are several rules, regulations, and guidelines to keep track of from multiple organizations. If your responsibilities for lab safety are…
Key Coverage Determinations and Product Developments
From - Laboratory Industry Report
Although several companies secured favorable diagnostic coverage determinations in March, the big winner was Vermillion, manufacturer of the…
CMS Exercises Enforcement Discretion for PAMA Reporting
From - G2 Compliance Advisor
As we previously reported, the Centers for Medicare & Medicaid Services (CMS) has indicated that laboratories had sought relief from the March 31 deadline for reporting applicable information under the…
Draft Legislation Proposes New Category for LDTs
From - National Intelligence Report
House of Representatives members Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) are looking for feedback on a discussion draft of legislation called the…