TAG:
association for molecular pathology
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
After SALSA Hits a Wall, New RESULTS Act Steps In
Upon reading the briefing in the last issue about the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, someof our members may have wondered,“What happened to SALSA?” SALSA, more formally known as the…
June 23, 2025, Intelligence: Late-Breaking Lab News
Clinical labs that have business in clinical trials involving genetic samples should note that on June 18, the Food and Drug Administration (FDA) ordered a review of new trials that send samples to “hostile countries for genetic engineering.” The FDA mentioned China specifically. Th…
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…
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 …
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…
What if Congress Chooses to Pass an LDT-Specific Law?
CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…
CURRENT ISSUE
Volume XXXII, No. 18 – December 29, 2025
The Dark Report reviews its top 10 stories from 2025, from the vacating of the FDA’s LDT rule to the merger of Waters and Becton Dickinson’s biosciences and diagnostics units. Also, a lab outlines its solution to a shortage of histotechnologists, and another story shows how pathologists can become patients’ partners.
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