Laboratory Developed Tests

Laboratory developed tests (LDTs) are at the forefront of clinical diagnostics innovation in many of our nation’s academic medical centers, particularly in the era of precision or personalized medicine. In New York, LDTs are subject to rigorous review by state regulators to ensure high quality and effective tests. GNYHA has long advocated against additional legislative and regulatory efforts to further regulate LDTs. While well intentioned, such efforts will disrupt innovation and materially interfere with the ability of medical centers to address the needs of their patients.

11 Items in Laboratory Developed Tests
FDA Issues Final Rule for LDTs with Continued Enforcement Discretion for NYS-Approved and Other Tests
May 1, 2024
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
FDA Finalizes Rule to Regulate Laboratory Developed Tests
April 26, 2024
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
House Energy and Commerce Committee Holds LDT Hearing
March 22, 2024
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
GNYHA Comments on FDA Proposal to Regulate Laboratory Developed Tests
December 11, 2023
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
GNYHA Responds to Proposed Rule to Regulate LDTs
December 8, 2023
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
FDA Issues Proposed Rule to Regulate LDTs
November 17, 2023
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
FDA Issues Proposed Rule to Regulate LDTs
October 27, 2023
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
Labarotory Developed Tests
October 25, 2023
Position
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
FDA Issues Proposed Rule to Regulate LDTs
October 13, 2023
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
GNYHA Advocacy for Laboratory Developed Tests (LDTs)
April 8, 2022
News
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment
Laboratory Developed Tests
March 30, 2022
Position
Government Affairs Federal Hospital Issues Laboratory Developed Tests
Goverment