FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
National Lab Reporter
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Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
10x Genomics Ordered to Pay $23.9 Million for Infringing Bio-Rad’s Patents
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Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back
From - National Intelligence Report
Although the False Claims Act (FCA) remains a federal enforcement cash cow, the growth rate has fallen off in recent years, at least in the…
New Law: EKRA Makes Drug Addiction & Rehab Labs Potential Targets for Federal Prosecution
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Industry Buzz: When It Comes to Obamacare, Uncertainty Is the Only Certainty
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The Worker Shortage and Your Lab
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Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
From - National Intelligence Report
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect…
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
LDTs: FDA Announces New Approach to 510(k) Approvals
From - National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
Post-PAMA: Government Report Warns of Medicare Overspending(!) for Lab Tests
From - National Intelligence Report
As if the deep price cuts inflicted by PAMA weren't infuriating enough, now the US Government Accountability Office (GAO) is claiming that…
