Top Articles
Congress May Soon Act on LDT, IVCT Regulation
Major changes in regulation of LDTs have the attention of many labs, IVD manufacturers
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes...
Florida Laboratory Owner Gets 82-Month Jail Term
Executive-owned labs in two states participated in scheme to defraud Medicare using false claims
CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who vi...
In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role
Who’s at fault? The lab director or Elizabeth Holmes?
CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question...
Regulatory Update Major CLIA Deficiencies Found at California's COVID-19 Lab Facility
News reports point to a possible double standard in how California regulates its own COVID-19 lab
MIGHT THERE BE DIFFERENT STANDARDS IN HOW government regulators enforce CLIA requirements on privately-owned clinical laboratories compared to a government-owned lab? This question is being asked after the California Department of Public Health (...
VALID Act vs. VITAL Act: Day of Reckoning for LDTs
TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests. One bill is called the Ver...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
Subscribe to The Dark Report for as little as $15.27 per week.
Get the most expert business intelligence for clinical laboratories and pathology groups available today. Subscribe to The Dark Report.
CURRENT ISSUE
Volume XXVIII, No. 16 – November 29, 2021
Two distinctly different bills have surfaced in Congress, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. Also, an attorney with decades of experience in advising clinical labs on CLIA matters analyzes the lessons to be learned for lab directors in the Elizabeth Holmes trial.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.