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IRVINE, Calif.—Seeking to detect prostate cancer at the earliest stage and to retest men previously diagnosed with false-negative biopsies, MDxHealth SA has announced positive data from two posters demonstrating the prognostic value of its brand ConfirmMDx for Prostate Cancer test at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco.
The data, presented in two separate poster presentations, demonstrated the test’s ability to detect an epigenetic field effect associated with the presence of anterior-predominant tumors missed in a previous negative biopsy and to identify patients likely to harbor clinically significant prostate cancer from negative biopsy tissue. In histopathology positive biopsies, the test showed a better separation between men with aggressive prostate cancer from those men with indolent disease.
“The principal aim of the test is to help prostate-cancer-free men from having to undergo unnecessary, invasive and painful repeat biopsies,” Dr. Jan Groen, CEO of MDxHealth, tells DDNews.
However, “the studies presented at ASCO GU demonstrate that ConfirmMDx may also help urologists detect cancer in a part of the prostate gland that is unreachable using standard biopsy needles,” he adds. “Additionally, the data suggest the test can aid in stratifying men who may have indolent versus aggressive forms of the disease to help guide treatment decisions.”
Of the two posters presented at the seminar, the first focused on anterior prostate tumors. Anterior-predominant prostate cancers (Pca) are poorly sampled by existing 12-core transrectal ultrasound-guided (TRUS) prostate needle biopsies, which is a serious issue given that roughly one-fifth of all prostate tumors occur in this area, many of which are high-grade and extend beyond the prostatic capsule. Seven patients, with at least one prior negative TRUS biopsy, were diagnosed with anterior-only PCa based on a transperineal mapping template prostate biopsy. Among these, six (86 percent) were methylation positive at initial biopsy, suggesting that the field effect from these anterior-predominant PCa extends to the region of TRUS biopsy sampling.
The second poster covered previous diagnostic studies that have established the utility of ConfirmMDx as a significant, independent predictor of prostate cancer, with a negative predictive value (NPV) of 90 percent for all cancers and a NPV of 96 percent for significant cancers. These data further validate the prognostic value of ConfirmMDx.
According to Goen, these data are important for MDxHealth as they provide further clinical validation for ConfirmMDx, which is rapidly gaining adoption among the urology community across the United States, and importantly, additional evidence that the test can not only aid in improved prostate cancer detection, but may also play a role in treatment decision-making.
One of the largest threats to men suffering from prostate cancer is that over 975,000 American men are diagnosed with a negative prostate biopsy each year, and 25 to 35 percent of those men receive false-negative results, giving these men false hope and false confidence which could lead to death from prostate cancer.
“Under the current standard of care, prostate biopsy procedures only sample approximately 1 percent of a man’s prostate,” Groen says. “This approach leaves men at risk of undetected cancer, leading to a high rate of repeat biopsies, even on cancer-free men.”
This represents a “significant unmet medical need for a clinically effective diagnostic test to address this dilemma, which we believe ConfirmMDx meets, by not only ‘ruling out’ men who should not need a repeat procedure, but also by ‘ruling in’ men at high risk of harboring the disease,” he notes.
There is an unmet medical need for a clinically effective diagnostic test to address this dilemma, Groen remarked. ConfirmMDx for Prostate Cancer is able to detect an epigenetic field effect or “halo” associated with the cancer process at the DNA level. This “halo” around a cancer lesion can be present despite cells having a normal appearance under the microscope, he explains. Thus, ConfirmMDx for Prostate Cancer aids urologists in identifying truly negative men who may forego an unnecessary repeat biopsy procedure.
While ConfirmMDx for Prostate Cancer is specifically designed to assess the risk for prostate cancer, Groen notes that “MDxHealth is exploring indications for advanced disease. MDxHealth has additional ‘liquid biopsy’ tests, SelectMDx and AssureMDx, and the company’s R&D efforts are focused on urologic cancers, including kidney cancer.”
Performance of the proprietary ConfirmMDx genes and technology has been published in 45 studies on over 5,000 patients tested. The ConfirmMDx test has qualified for Medicare reimbursement as of Nov. 3, 2014.