RE: RNS22 Oct 2024 13:10
Oxford, UK - 22 October 2024 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a precision clinical diagnostics company bringing specific and sensitive tests to the practice of medicine based on OBD's EpiSwitch® 3D genomics platform, and its partner NEXT Molecular Analytics (VA, USA) have been informed of New York State Clinical Laboratory Evaluation Program's (NYS CLEP) approval of the EpiSwitch® CiRT Test.
"This is a significant milestone for any laboratory-developed test (LDT), including the CiRT test, and for the EpiSwitch platform." stated Thomas Guiel, Chief Operating Officer, "NYS CLEP is a rigorous program which bears similarities to the FDA premarket review process1. Both programs seek to mitigate the risks of harm from inaccurate and potentially unreliable LDTs. In the FDA's final ruling on LDTs earlier this year, they stated that they would not enforce their premarket review process for LDTs approved by NYS CLEP."
"NYS CLEP provides an independent review of the analytical and clinical validity of any test. OBD and NEXT Molecular have been notified that the CiRT Test has passed this evaluation and been approved for clinical use."
The FDA News release of 29 April 20241 states: "The FDA has also included additional enforcement discretion policies, such as for LDTs approved by the New York State's Clinical Laboratory Evaluation Program (CLEP), as described in the preamble to the final rule, where that program's review of analytical and clinical validity helps to mitigate the risk of harm from inaccurate and unreliable LDTs."
1 - FDA News Release, FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests | FDA
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