Coinciding with Prostate Cancer Awareness month, OBD has brought forward the launch of its highly accurate, 94% precision medicine test to make it immediately available to men being screened for prostate cancer. This includes those who have received an elevated prostate-specific antigen (PSA) result as well as many others where prostate cancer is a clinical concern.
EpiSwitch Prostate Screening test (PSE)
The current blood screening test, the PSA test, is only 55% accurate, and is considered an unreliable test by many doctors, including the
The PSE test is the culmination of nearly a decade's long collaboration between OBD,
The PSE test is designed to run alongside a standard PSA test, and combines the PSA score with five proprietary epigenetic biomarkers to predict, with 94% accuracy, the presence (or absence) of prostate cancer.2 Those with a PSE result of low likelihood of cancer can be placed on active surveillance and retested later without being referred for an invasive and often destructive biopsy. A high likelihood result would necessitate referral to a Urologist for further investigation.
As well as very high accuracy, PSE has high specificity of 97% (PSA: 53%) and sensitivity of 86% (PSA: 64%), along with both high positive, 93% (PSA: 25%), and high negative, 95% (PSA: 86%), predictive values to assess the risk of prostate cancer in men.2 It has been validated as a laboratory developed test (LDT) in OBD's CLIA-certified testing laboratory in
'PSE is a diagnostic prostate cancer test with unprecedented accuracy.' said
The Company is continuing to work alongside the
The PSE test is being launched during Prostate Cancer Awareness month to introduce both physicians and patients to the benefits of this highly accurate blood test. Before today, following an elevated PSA result, men and their primary care physicians faced the cancer screening dilemma; retest PSA even with its low accuracy, schedule an MRI or send the patient, maybe needlessly, for an invasive biopsy.3 This is where the 94% accurate PSE can resolve the conundrum. Because PSA is just one component of the PSE test, PSE works with all PSA values from low to high as not all high PSA values will return a high likelihood result just as some low PSA values will.
'Although the traditional PSA has demonstrated clinical utility in prostate cancer screening and monitoring, it also has limitations that are well-described,' said Dr.
Patients should speak to their doctor about ordering the PSE test. Their doctor will submit a test requisition and arrange for a small sample of the patient's blood to be collected. Test results will be returned to the ordering physician within five days after the blood sample is received in the laboratory.
The PSE test will be immediately available to men in the
'There is a clear need in everyday clinical practice for a much more accurate blood test that can screen men for prostate cancer and accurately identify those at risk, while sparing those who up to now would be subject to unnecessary, expensive, and invasive procedures. It feels wholly appropriate that the early launch of the test coincides with Prostate Cancer Awareness month,' said Dr
Contact:
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Email: OxfordBioDynamics@instinctif.com
About
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
In
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
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
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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