TAG:
FDA
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….
Congress May Soon Act on LDT, IVCT Regulation
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
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
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…
Former Theranos Lab Director Makes News at Elizabeth Holmes Trial
This is an excerpt of a 1,867-word article in the October 18, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: During the trial, a pathologist who was a former Theranos lab director testified about the little…
Pathologist Makes News at Elizabeth Holmes Trial
CEO SUMMARY: During the trial, a pathologist who formerly was CLIA lab director at Theranos testified about the little regard Theranos executives had for federal proficiency testing regulations labs must follow to retain their CLIA license. Another point of contention was how this p…
Artificial Intelligence: Coming at Light Speed!
YOU HAVE PROBABLY NOTICED THAT THE TERM “ARTIFICIAL INTELLIGENCE” is now part of the description for a growing proportion of the new products and services being offered to your clinical laboratory or anatomic pathology group. Regardless of whether it is automation, analyzers, or software, the claim…
First Digital Path AI Tool Cleared for Market by FDA
CEO SUMMARY: In a first for the anatomic pathology profession, the Food and Drug Administration (FDA) has cleared for market a digital pathology image analysis product intended to aid pathologists in the diagnosis of prostate cancer. Developed by New York City-based Paige, the Paige…
Paige’s Digital AI Tool Aids in Prostate Cancer Diagnosis
CEO SUMMARY: Study data provided to the FDA “demonstrated increased diagnostic accuracy” when pathologists used the Paige Prostate system, said Paige’s Medical Director. The artificial intelligence-powered pathology image analysis tool is trained to help pathologists detect ev…
Digital Pathology Image Service Delivers AI via the Internet
IN GERMANY, AN EMERGING DIGITAL PATHOLOGY (DP) COMPANY has introduced a novel feature that could be a low-cost way for pathology groups to access artificial intelligence (AI) for digital image analysis. This would appeal to pathologists who may be reluctant to invest the substantial cost and time req…
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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