MDxHealth, a leading company in molecular diagnostics specializing in the development and commercialization of epigenetic tests to support cancer research, announces major milestone in growth and development with the launch of their first proprietary product: ConfirmMDxTM for Prostate Cancer.
ConfirmMDxTM for Prostate Cancer is an innovative epigenetic test designed to help urologists differentiate the true-negative prostate biopsy patients from those with occult cancer.
The ConfirmMDxTM for Prostate Cancer test is designed to “confirm” a negative biopsy test that is often missed by sampling error, biopsy or histopathological review, therefore allowing these patients to avoid repeat biopsy. Roughly one quarter of the men presenting a preliminary negative histopathology result, could still be camouflaging cancer. Many of the patients fearing this end up having repeated visits, further screenings and unnecessary biopsies although most are prostate cancer free. This test is a wonderful aid that will give the urologist the ability to distinguish between those patients that need further testing and those that may not, therefore preventing the “ true-negative” patient from having to go through repeat biopsy.
MDxHealth’s innovative CLIA laboratory (Irvine, Ca.) is currently testing prostate tissue samples received directly from physicians or through their co-marketing partner PLUS Diagnostics. Performance of the genes currently being used along with the proprietary technology has already been studied in over 4000 patients with respective journal publications in over 40 countries worldwide.
Recently, data from the multicenter, MATLOC (Methylation Analysis To Locate Occult Cancer) involving three sites from the UK and Belgium, were presented in May at the AUA(American Urology Association) Conference in Atlanta. Results from the study showed that ConfirmMDxTM for Prostate Canceris a powerful aid for urologists when dealing with the issues arising from false-negative tests.
Dr. Grant Stewart (Edinburgh Urological Cancer Group, University of Edinburgh, UK) explained, “the test can help urologists confirm true-negative biopsy results, providing peace-of-mind and reducing unnecessary repeat biopsies.” In a Q & A session during the conference Stewart also stated that, “men with normal, or ‘benign’ biopsy findings, would benefit by having their biopsy tissues tested with ConfirmMDx.” In other words, the result of this test would help both the urologist and the patient decide if a repeat prostate biopsy would be necessary.
Consequently, because biopsies present certain risks, many men refuse to undergo repeated biopsies even though they fear their initial biopsy has presented a false–negative result. These patients that avoid additional testing may be putting themselves at a greater risk of undetected cancer and advanced progression of the disease. Overall, this test will provide a more effective sorting of high-risk patients from true-negative patients, thereby reducing unwanted invasive procedures and the issues such as infection and trauma that are associated with these procedures.
As of today, the ConfirmMDx TM for Prostate Cancer is now readily available to urologists either through MDxHealth’s CLIA laboratory in Irving, or via their co-marketing partner PLUS Diagnostics.
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