TDR Insider
With LDT Rule Vacated, Labs Await FDA Response
In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form is likely. In part one of ...
The Role of Price Transparency During Pathology Contract Talks
Pathology groups have a much better opportunity to turn the tables on payers and other third parties during contract negotiations if they come armed with the data and other information recommended by two well-respected pathology experts. In this final installment of our four-part series...
Medical Robotics Developer Believes It’s Time to Transform Phlebotomy
Phlebotomy and collection of veinous blood is one important procedure in clinical laboratory testing that continues to be primarily a manual process. That is about to change. Netherlands-based Vitestro has obtained a CE mark in the European Union for its novel autonomous robotic phlebotomy device (AR...
Why Labs Should Comply with the FDA’s Final Rule on LDTs
On April 29, 2024, the Food and Drug Administration released its final rule on regulation of laboratory developed tests (LDTs). Since then, clinical laboratories have grappled with questions surrounding compliance, while hoping that courts will step in and prevent the rule from taking effect. Now,...
OIG Issues New Report on Medicare 2023 Lab Spending
WITHIN THE LATEST REPORT ON MEDICARE PART A CLINICAL LABORATORY SPENDING during 2023 is information about the financial impact that price cuts to the Clinical Laboratory Fee Schedule (CLFS) have had on clinical laboratories. As mandated by the Protecting Access to Medicare Act of 2014 (PAMA), the rep...
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final ...
Top 10 Lab Stories for 2024 Do Reflect Important Trends
Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the final rule. However, ...
Two Different LDT Lawsuits Are Combined in Federal Court
Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern District of Texas, which ...
Internet Tracking Lawsuits Are Targeting Quest and Labcorp
QUEST DIAGNOSTICS AND LABCORP, THE TWO GIANTS OF THE U.S. CLINICAL LABORATORY BUSINESS, are among many companies across a wide range of industries facing class-action lawsuits over their use of tracking technologies designed to facilitate online advertising. This ...
Four Independent Health Systems Launch ‘Longitude Health’
For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Longitude Health joins Risant Health as the newest attempt to bring together different health systems and foster collaboratio...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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