REG - Oxford BioDynamics - OBD receives reimbursement code for PSE test

Oxford BiodynamicsAnnouncement

03/10/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231003:nRSC4364Oa&default-theme=true

RNS Number : 4364O  Oxford BioDynamics PLC  03 October 2023

Oxford BioDynamics receives reimbursement code for

EpiSwitch® Prostate Screening (PSE) Test

 

·   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, UK - 3 October 2023 - 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
(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
(http://www.94percent.com) .

 

-Ends-

For further details please contact:

 Oxford BioDynamics Plc               +44 (0)1865 518910

 Jon Burrows, CEO

 Paul Stockdale, CFO

 Shore Capital                        +44 (0)20 7408 4090

 Nominated Adviser and Broker

 Stephane Auton

 Iain Sexton

 Instinctif Partners                   +44 (0)20 7457 2020

 Melanie Toyne-Sewell / Rozi Morris   OxfordBioDynamics@instinctif.com (mailto:OxfordBioDynamics@instinctif.com)

 Adam Loudon / Jack Kincade

 

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
(https://url.avanan.click/v2/___https:/www.mycirt.com/___.YXAxZTpzaG9yZWNhcDphOm86OTRjOGE5ZDRmYWIwMTc2MWFhZjYyZTZkMWJhZTFmNDg6NjphN2EwOmU5ZDc2NmYxZjYxNTk4OGE3YzY3NzkzYWRmODlmMmZmMzBmZmU2ZDZlZmNhMWI0ZmRlYjE3Nzc5N2Q4NmUzZTc6cDpU)
(Checkpoint Inhibitor Response Test) and EpiSwitch® PSE
(http://www.94percent.com) (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
(https://url.avanan.click/v2/___https:/covidseveritytest.com/___.YXAxZTpzaG9yZWNhcDphOm86OTRjOGE5ZDRmYWIwMTc2MWFhZjYyZTZkMWJhZTFmNDg6NjpmZWY1OmMzOGIyYTk2Yjk1OTgyMDNlMGFkNmQwZGU3ZmNmYzQwMzZmMGIwZDQ5NzA0OTAzNDc0NzY2ZDQyZGZiYjk5YWU6cDpU)
(Covid Severity Test) and the first commercially available microarray kit for
high-resolution 3D genome profiling and biomarker discovery, EpiSwitch®
Explorer Array Kit
(https://url.avanan.click/v2/___https:/store.oxfordbiodynamics.com/___.YXAxZTpzaG9yZWNhcDphOm86OTRjOGE5ZDRmYWIwMTc2MWFhZjYyZTZkMWJhZTFmNDg6NjpiMWU2OjMzMTc0NWQ5ZWZhODg0MmY1N2EzZjY2YWRkZDI5YjBkOTRhM2M0ZTZkOGJkNWM2Y2I5MDE4MmQ4M2Y4ZjViMDY6cDpU)
, 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
(https://url.avanan.click/v2/___http:/www.oxfordbiodynamics.com___.YXAxZTpzaG9yZWNhcDphOm86OTRjOGE5ZDRmYWIwMTc2MWFhZjYyZTZkMWJhZTFmNDg6Njo3ZjFmOjUxZjRiNmRmMzBiMGI3ZjA2NDJjNjFkZTc2MTM5MThjYjUxZGNiN2ZhNmRhNWRkMjY0MTAwNWY4ODA3ZjE4ZjU6cDpU)
, or follow OBD on Twitter
(https://url.avanan.click/v2/___https:/twitter.com/OxBioDynamics___.YXAxZTpzaG9yZWNhcDphOm86OTRjOGE5ZDRmYWIwMTc2MWFhZjYyZTZkMWJhZTFmNDg6NjplM2FmOjIwMTI1ZWNlOWJkYjRjZDQ1YjA4YWI2NDc0NWY1OWYzNzg1NTEzYjM0NjIwYTZmNTljNjk0YTQ1YzBkMjg0OTM6cDpU)
(@OxBioDynamics) and LinkedIn
(https://url.avanan.click/v2/___https:/www.linkedin.com/company/oxford-biodynamics___.YXAxZTpzaG9yZWNhcDphOm86OTRjOGE5ZDRmYWIwMTc2MWFhZjYyZTZkMWJhZTFmNDg6Njo2YjgzOjcwMGI3YTM5ODdkMDVmNjA5ZDgxN2FmYWVjYTJkMjIzM2E3NTgzYzM0ZGIzMGIyZDIyYWZlZTVjN2QyZmY4ZGQ6cDpU)
.

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.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. 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  MSCNKBBQABDDKKK