- EpiSwitch PSE boosts the predictive accuracy of current
standard PSA test from 55%, to 94% for determining the presence or
absence of prostate cancer
- CPT PLA Code 0433U has been issued to Oxford BioDynamics for
insurance reimbursement under Medicare, Medicaid and private
payors
- The CPT PLA Application for PSE was filed on July 5 and granted
by the American Medical Association (AMA) less than 3 months after
filing
- New code available for use from 1 January 2024 for insurance
reimbursement (Medicare, Medicaid or private payors)
- A unique reimbursement code aids the billing process and
reinforces physician confidence
Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology
company developing precision medicine tests based on the EpiSwitch
3D genomics platform, confirms the assignment and publication of a
Proprietary Laboratory Analysis Code (PLA Code) by the American
Medical Association’s CPT (Current Procedural Terminology)
Editorial Board
(https://www.ama-assn.org/practice-management/cpt/cpt-pla-codes).
The unique code, 0433U, was issued to Oxford BioDynamics for the
94% accurate EpiSwitch® Prostate Screening (PSE) test. The code was
published on 29 September and payors will be able to bill for the
test using the code from 1 January 2024. A miscellaneous code for
high complexity molecular testing will be used for reimbursement
until the unique code goes live.
The new CPT code provides a standardized billing mechanism for
the PSE Test across all US healthcare providers, ensuring accurate
reimbursement. This development ensures patients have greater
access to the test by simplifying the reimbursement process and
eliminating administrative complexity.
The PSE Test was launched on September 26, ahead of schedule,
and has been made immediately available to men in the US and UK
being screened for prostate cancer. It was launched as a Laboratory
Developed Test (LDT) to provide immediate access for men where
prostate cancer is a clinical concern and to generate clinical
utilization for the test.
Despite the AMA’s commitment to issuing CPT codes in a timely
manner it is often a difficult task for companies to navigate the
process and it can take up to 2 years.
OBD’s management believes that the speed of issuance of the CPT
code demonstrates that the payor groups recognize how important PSE
is for screening, not only for the patients, but also for the
savings to the medical industry.
“A unique code is critical to the reimbursement process,” said
Thomas Guiel, OBD’s Chief Operating Officer. “With the code
issued at this early stage of the test introduction, we are in a
good place to drive adoption of this highly accurate test.
Effective on 1 January for all requests for insurance
reimbursement, whether from Medicare, Medicaid or private payors,
this unique code will enable discussions regarding coverage
decisions as well as negotiating the reimbursement rate.”
As with the Company’s previous test, the checkpoint inhibitor
response test (CiRT), launched in early 2022 for prediction of
response to checkpoint inhibitor therapy in cancer, a miscellaneous
code for high complexity molecular testing will be used for
reimbursement in the fourth quarter of 2023. A CPT PLA code is
unique to the test, the lab and the manufacturer. The full (long)
description for PSE is “Oncology (prostate), five DNA regulatory
markers by quantitative PCR, whole blood, algorithm, including
Prostate-Specific Antigen, reported as likelihood of cancer”.
For more about EpiSwitch PSE, please visit www.94percent.com
-Ends-
About Oxford BioDynamics Plc
Oxford BioDynamics Plc (AIM: OBD) is a global biotechnology
company, advancing personalized healthcare by developing and
commercializing precision medicine tests for life-changing
diseases.
Its flagship products are the EpiSwitch® CiRT (Checkpoint
Inhibitor Response Test) and EpiSwitch® PSE (EpiSwitch Prostate
Screening test) blood tests. CiRT is a predictive immune response
profile for immuno-oncology (IO) checkpoint inhibitor treatments,
launched in February 2022. PSE is a blood test that boosts the
predictive accuracy of a PSA test from 55% to 94% when testing the
presence or absence of prostate cancer, which has been launched in
the US and UK in September 2023.
In March 2021, the Company launched its first commercial
prognostic test, EpiSwitch® CST (Covid Severity Test) and the first
commercially available microarray kit for high-resolution 3D genome
profiling and biomarker discovery, EpiSwitch® Explorer Array Kit,
which is available for purchase by the life science research
community.
The Company’s product portfolio is based on a proprietary 3D
genomic biomarker platform, EpiSwitch®, which can build molecular
diagnostic classifiers for the prediction of response to therapy,
patient prognosis, disease diagnosis and subtyping, and residual
disease monitoring in a wide range of indications.
Oxford BioDynamics has participated in more than 40 partnerships
with big pharma and leading institutions including Pfizer, EMD
Serono, Genentech, Roche, Biogen, Mayo Clinic, Massachusetts
General Hospital and Mitsubishi Tanabe Pharma.
The Company has created a valuable technology portfolio,
including biomarker arrays, molecular diagnostic tests,
bioinformatic tools for 3D genomics and an expertly curated 3D
genome knowledgebase comprising hundreds of millions of data points
from over 15,000 samples in more than 30 human diseases.
OBD is headquartered in Oxford, UK and is listed on AIM of the
London Stock Exchange. It also has a commercial office in
Gaithersburg and a clinical laboratory in Frederick, MD, USA, and a
reference laboratory in Penang, Malaysia.
For more information, please visit the Company's website,
www.oxfordbiodynamics.com, or follow OBD on Twitter
(@OxBioDynamics) and LinkedIn.
About EpiSwitch®
The 3D configuration of the genome plays a crucial role in gene
regulation. By mapping this architecture and identifying abnormal
configurations, EpiSwitch® can be used to diagnose patients or
determine how individuals might respond to a disease or
treatment.
Built on over 10 years of research, EpiSwitch® is Oxford
Biodynamics' award-winning, proprietary platform that enables
screening, evaluation, validation and monitoring of 3D genomic
biomarkers. The technology is fully developed, based on testing of
over 15,000 samples in 30 disease areas, and reduced to
practice.
In addition to stratifying patients with respect to anticipated
clinical outcomes, EpiSwitch® data offer insights into systems
biology and the physiological manifestation of disease that are
beyond the scope of other molecular modalities. The technology has
performed well in academic medical research settings and has been
validated through its integration in biomarker discovery and
clinical development with big pharma.
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version on businesswire.com: https://www.businesswire.com/news/home/20231003373303/en/
For further details please contact: Oxford BioDynamics
Plc Jon Burrows, CEO Paul Stockdale, CFO +44 (0)1865 518910
Shore Capital Nominated Adviser and Broker Stephane
Auton Iain Sexton +44 (0)20 7408 4090 Instinctif
Partners Melanie Toyne-Sewell / Rozi Morris Adam Loudon / Jack
Kincade +44 (0)20 7457 2020 OxfordBioDynamics@instinctif.com
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