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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Whole-Genome Sequencing Can Improve Blood Transfusion Matches
From - Diagnostic Testing & Emerging Technologies
Antigen typing based on whole-genome sequencing (WGS) can enable more precise matching of blood transfusions, according to a study published online May 17 in…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: Anthem Blue Cross Blue Shield is suing Reliance Laboratory Testing for allegedly conspiring with California hospital Sonoma West Medical Center to create a fraudulent…
FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
Case of the Month: Individual Principles Hit with $114.1 Million Verdict for Role in HDL Blood Test Fraud
From - National Intelligence Report
Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and…
Industry Buzz: LabCorp and Quest Swept Up in Insurance Contract Partner Swap
From - Laboratory Industry Report
Can you imagine Scarlett and Rhett swapping partners with Romeo and Juliet? Something like the laboratory industry equivalent of that scenario took place on…
The End May Be Near for Theranos & Elizabeth Holmes
From - G2 Compliance Advisor
Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of…
Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval
From - Laboratory Industry Report
"Great news! The FBI just called."
–Extremely rare phrase almost never uttered except sarcastically…
Report Finds Genetic Tests and Their Reimbursement Increasingly Complex
From - Diagnostic Testing & Emerging Technologies
The health care technology company Concert Genetics (formerly NextGxDx; Nashville, Tenn.) recently released its third edition of…
How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…