RCS - Oxford BioDynamics - CiRT Receives Clinical Approval from NYS CLEP

Oxford BiodynamicsAnnouncement

22/10/2024 13:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241022:nRSV1667Ja&default-theme=true

RNS Number : 1667J  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 process(1).  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 2024(1) 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
(https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests)

-Ends-

For more information:

 Oxford BioDynamics Plc                  +44 (0)1865 518910

Jon Burrows, CEO

Paul Stockdale, CFO
 Shore Capital                           +44 (0)20 7408 4090

(Nominated Adviser and Broker to OBD)

Stephane Auton

Lucy Bowden
 WG Partners (Joint Broker to OBD)       +44 (0)20 3705 9330

David Wilson / Claes Spång /

Satheesh Nadarajah / Erland Sternby
 Vigo Consulting                         +44 (0)20 7390 0230
 (Media / Analyst enquiries for OBD)
obd@vigoconsulting.com

Rozi Morris

 

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
(https://url.avanan.click/v2/___http:/www.94percent.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjphZTRmOjE1ZmE3ZTA1NmFmMzlmYjIzZmFhOGU1NTc5MWI0OTdiODZmMjVmOTFlOWQ2YjBiZTM3YmNmMTMxMGYxOTcxMjI6cDpU)
(EpiSwitch Prostate Screening test) and EpiSwitch® CiRT
(https://url.avanan.click/v2/___https:/www.mycirt.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjpjZGI4OjQ3ZWJmMjU3YzNhNjYzYzNiYWVjZGNlMTJjZDM5ZGZkYzBlNmQyNTc0OTdlZWU4ZGI4ODFlYzU1OWZmN2JmMWE6cDpU)
(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
(https://url.avanan.click/v2/___http:/www.oxfordbiodynamics.com___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6Njo3YmRiOmUxODM2ZWZhYmIxNjdhMjFiNTMxOThjNjE0YzMwYzg5YzA1MjI2MmYxMGY0ZTU1MzdjYzdlYzg1NDA5ZTcyOWU6cDpU)
,  X (@OxBioDynamics) or LinkedIn
(https://url.avanan.click/v2/___https:/www.linkedin.com/company/oxford-biodynamics___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjozM2I4OmVmNzdkN2M0NmYxZDg3ODc0MWQ1NDEyMGQ4MjAxOWVmMTg4ZTMzNWY4MTA5NGE3NTE5ZDdlNWIwNjI5MTRhMTM6cDpU)
.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAFEWFFEELSEIS