TAG:
AMP
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue
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
By R. Lewis Dark | From the Volume XXXII, No. 1 – January 6, 2025 Issue
Given the popular sentiment that artificial intelligence (A…
Two Different LDT Lawsuits Combined in Federal Court
By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue
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
By R. Lewis Dark | From the Volume XXXI, No. 12 – September 3, 2024 Issue
THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…
September 3, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
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…
September 19, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 13 – September 19, 2022 Issue
Déjà vu? Lawmakers in Congress question whether public health officials have done enough to stay ahead of monkeypox, including the availability of diagnostic tests. Concerns about such testing came up during a Sept. 14 hearing before the Senate’s Health, Education, Labor, and Pensions Committee. …
Congress May Soon Act on LDT, IVCT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
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…
Congress May Soon Act on IVCT, LDT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
Post-COVID: Repurposing Excess PCR Instruments
By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…
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