New Report Sheds Light on Effectiveness of Federal Government’s Response to Need for COVID-19 Testing
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January 1, 2021 Is D-Day for Hospital Pricing Transparency
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Industry Trends: Continued Momentum for Lab-Retail Collaboration
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6 Steps to Data-Driven Transformation
By Nir Kaldero bio
We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the…
Industry Buzz: ACA Constitutionality Is Back in Play
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Cost Avoidance vs Cost Savings: What’s the Difference?
By Jennifer Dawson, MHA, DLM (ASCP) bio
As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to demonstrate…
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From - National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
Are Genetic Testing Labs Liable for Medical Malpractice?
From - National Intelligence Report
Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth…
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
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Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
From - National Intelligence Report
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements…