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
|
+44
(0)1865 518910
|
|
Shore Capital
(Nominated Adviser and Broker to OBD)
Stephane Auton
Lucy Bowden
|
+44 (0)20
7408 4090
|
|
WG
Partners (Joint Broker to
OBD)
David Wilson / Claes Spång /
Satheesh Nadarajah / Erland Sternby
|
+44
(0)20 3705 9330
|
|
Vigo
Consulting
(Media / Analyst enquiries
for OBD)
Rozi Morris
|
+44 (0)20
7390 0230
obd@vigoconsulting.com
|
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.