MDxHealth’s ConfirmMDx™ for Prostate Cancer Test Helps to Identify Men Able to Avoid Repeat Biopsies

May 23, 2012 02:00 AM Eastern Daylight Time  IRVINE, Calif. & LIEGE, Belgium--(BUSINESS WIRE)--Regulatory News: “With a high negative predictive value, exceeding that of standard microscopic histopathology review, the MATLOC study results demonstrate that the ConfirmMDx for Prostate Cancer test can help urologists confirm true-negative biopsy results, providing peace-of-mind and reducing unnecessary repeat biopsies” . MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced it has presented data demonstrating that its epigenetic ConfirmMDx™ for Prostate Cancer test can aid urologists in identifying patients who may avoid a repeat prostate biopsy.In men suspected to have prostate cancer, the potential for false-negative biopsy results is well documented in the literature. Approximately twenty-five percent of men receiving a negative histopathology result, the gold standard for diagnosis, could be harboring occult cancer. Fear over this issue leads to additional physician visits, screening, and repeat biopsies, often on prostate-cancer-free men. MDxHealth’s ConfirmMDx test assesses the DNA methylation status of genes associated with prostate cancer. The test will help urologists differentiate patients with a true-negative biopsy from those who may have cancer undetected by prostate biopsy and histopathological review.The data from the MATLOC (Methylation Analysis To Locate Occult Cancer) study presented during the Late Breaking Science Forum yesterday at the American Urology Association (AUA) Annual meeting in Atlanta, USA, revealed that the ConfirmMDx for Prostate Cancer test is a powerful tool to aid urologists in addressing false-negative biopsy concerns."With a high negative predictive value, exceeding that of standard microscopic histopathology review, the MATLOC study results demonstrate that the ConfirmMDx for Prostate Cancer test can help urologists confirm true-negative biopsy results, providing peace-of-mind and reducing unnecessary repeat biopsies,” explained principle investigator Dr. Grant Stewart from the Edinburgh Urological Cancer Group at the University of Edinburgh, who presented the data. “The test will also help urologists identify high-risk men who may have occult cancer, enabling more effective triage of these patients with a repeat biopsy and treatment as required.""These data confirm the high negative predictive value (NPV) and clinical utility of the ConfirmMDx for Prostate Cancer genes and DNA methylation technology previously reported in published studies. We believe the test fulfills an unmet medical need, complementing the current standard of care, and holds the potential to reduce unnecessary invasive procedures and the associated healthcare expenditures. Prostate biopsies pose significant risk of trauma and infection, at times requiring hospitalization. As a consequence, approximately one-third of men refuse to endure a repeat biopsy despite fear of a false-negative result, leaving these men at risk for disease progression. ConfirmMDx, a non-invasive assay performed on the residual prostate tissues from the previous negative biopsy, provides critical insights beyond histopathology to enable more informed patient management decisions," said Dr. Jan Groen, CEO of MDxHealth. "We are pleased to announce that ConfirmMDx for Prostate Cancer is now available to urologists directly through MDxHealth’s state-of-the-art CLIA laboratory, and via our co-marketing partner PLUS Diagnostics.”

Study Details The multicenter MATLOC study involved 3 sites from the UK and Belgium, testing tissue from initial negative biopsies and comparing assay results to cancer detection in subsequent biopsies within 30 months revealing either cancer (cases) or negative results (controls). Individual prostate biopsies comprised 10 separate tissue cores on average. ConfirmMDx for Prostate Cancer was used to analyze the methylation status of a panel of validated biomarkers (GSTP1, APC and RASSF1) in 4,681 archived prostate biopsy cores from 483 men in a blinded fashion. Results demonstrated that the assay had a NPV of 90%Application of this assay to initial, negative prostate biopsies accurately identified over two-thirds of patients who had cancer detected on a subsequent prostate biopsy, while correctly confirming negative findings in approximately two-thirds of men who were cancer-free in a subsequent prostate biopsy. The high NPV of 90% indicates this assay could help avoid unnecessary repeat prostate biopsies.Approximately 60% of positive assay results were indicated by one methylated gene while the remaining 40% of cases displayed two or more methylated genes. Univariate analyses identified that the methylation panel was a significant predictor of prostate cancer diagnosis. These findings were confirmed with a multivariate logistic regression, correcting for PSA, age, digital rectal examination results prior to initial biopsy and histopathological findings of this biopsy.The study entitled “Clinical utility of a multiplexed epigenetic gene assay to detect cancer in histopathologically negative prostate biopsies: results of the multicenter MATLOC study”, was presented by Dr. Grant Stewart from the Edinburgh Urological Cancer Group at the University of Edinburgh, on Tuesday, May 22, 2012 during the late breaking science session. Abstracts from the conference are available online.

About ConfirmMDx for Prostate CancerOver 650,000 American men receive a negative prostate biopsy result each year; however approximately 25-35% of these results are false negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 1% of a man’s prostate. This approach leaves men at risk of occult cancer, leading to a high rate of repeat biopsies, often on prostate-cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or “halo” associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying men who may forego unnecessary repeat biopsies.

About MDxHealthMDxHealth is a leading molecular diagnostics company that develops and commercializes epigenetic tests to support cancer treatment. The company’s tests are based on proprietary gene methylation (epigenetics) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit http://www.mdxhealth.com and follow us on Twitter at: http://www.twitter.com/mdxhealth.