CiRT Receives Clinical Approval from NYS CLEP

Oxford BioDynamics PLC

22 October 2024

 

Oxford BioDynamics
("OBD" or the "Company" and, together with its subsidiaries, the "Group")

EpiSwitch® CiRT Receives Clinical Approval from 
New York State Clinical Laboratory Evaluation Program (NYS CLEP)

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

-Ends-

For more information:

Oxford BioDynamics Plc Jon Burrows, CEO Paul Stockdale, CFO	[phone]
Shore Capital (Nominated Adviser and Broker to OBD) Stephane Auton Lucy Bowden	[phone]
WG Partners (Joint Broker to OBD) David Wilson / Claes Spång / Satheesh Nadarajah / Erland Sternby	[phone]
Vigo Consulting (Media / Analyst enquiries for OBD)  Rozi Morris	[phone] [e-mail]

Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is an international biotechnology company, advancing personalized healthcare by developing and commercializing precision clinical diagnostic tests for life-changing diseases.

Currently OBD has two commercially available products: the EpiSwitch® PSE (EpiSwitch Prostate Screening test) and EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) blood tests. PSE boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer. CiRT is a highly accurate (85%) predictive response test to immuno-oncology checkpoint inhibitor treatments.

The tests are based on OBD's proprietary 3D genomic biomarker platform, EpiSwitch® which enables screening, evaluation, validation and monitoring of biomarkers to diagnose patients or determine how individuals might respond to a disease or treatment.

OBD's clinical smart tests have the potential to be used across a broader range of indications, and new tests are being developed in the areas of oncology, neurology, inflammation, hepatology and animal health.

The Group's headquarters and UK laboratories are in Oxford, UK. Its US operations and clinical laboratory are in Maryland, USA, along with a reference laboratory in Penang, Malaysia.

OBD is listed on the London Stock Exchange's AIM (LSE: OBD). For more information, please visit the Company's website, www.oxfordbiodynamics.com,  X (@OxBioDynamics) or LinkedIn.

 

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