TAG:
Food and Drug Administration
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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Assessing the Clinical Service & Revenue Issues of the LDT Rule
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
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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