TAG:
American Clinical Laboratory Association
Lab Stakeholders Discuss PAMA Reform
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: 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…
Upcoming Executive War College to Cover Important Lab Trends
New developments now changing the landscape in health-care and the clinical laboratory market will be addressed at the upcoming 30th Annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management that happens on April 29-30, 20…
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
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 …
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: 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 …
Unpacking the Surprises in the FDA LDT Rule
THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…
September 3, 2024, Intelligence: Late-Breaking Lab News
To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…
Identifying Current Lab Trends from Labcorp & Quest Experience
CEO SUMMARY: Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. Wi…
CURRENT ISSUE
Volume XXXII, No. 12 – August 25, 2025
In an exclusive interview, a laboratory industry M&A specialist discusses what’s driving lab outreach sales to national lab companies. Also, The Dark Report analyzes ways in which pathology and clinical labs can profitably partner with pharmaceutical companies.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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