TAG:
FDA
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…
Top 10 Lab Stories for 2024 Reflect Important Trends
CEO SUMMARY: 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…
November 25, 2024, Intelligence: Late-Breaking Lab News
Disruption is happening in the consumer genetic testing marketplace. In recent weeks, news outlets in the United Kingdom reported that Atlas Biomed, a consumer genetic testing company founded in 2016, had simply “disappeared.” Malwarebytes said Atlas Biomed’s “London offices …
129,624 Genetic Tests in the United States
REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…
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 …
November 4, 2024, Intelligence: Late-Breaking Lab News
Artificial intelligence (AI) is coming to the federal Food and Drug Administration (FDA) and the Veterans Administration (VA). Last week, on Oct. 30, the two agencies issued an announcement that they would partner “to launch an interagency testing ground forchealth…
October 14, 2024, Intelligence: Late-Breaking Lab News
Babson Diagnostics of Austin, Texas, received a “strategic investment” from Becton, Dickinson and Company (BD). The amount of the investment was not disclosed. In the past year, Babson launched an innovative lab testing service with retail pharmacies in Austin an…
Lab Innovators in Europe Have Solutions for USA
CEO SUMMARY: Rapid advances in a wide range of technologies over the past 15 years are enabling entrepreneurs to create transformative products for use by clinical laboratories and anatomic pathology groups. The Dark Report recently toured Europe to visit several such innovative companies…
Hurdles Continue When Labs Request Genetic Test Coverage
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CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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