Prostate Ca assay helps distinguish negative biopsy results from occult disease

MDxHealth SA (Irvine, CA) has announced the launch of ConfirmMDx for Prostate Cancer, an epigenetic assay that helps urologists distinguish patients who have a true-negative prostate biopsy from those who may have occult cancer.

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, according to MDxHealth. This molecular halo around a cancer lesion can be present despite having a normal appearance under the microscope.

Testing will be performed in MDxHealth's state-of-the-art Clinical Laboratory Improvements Amendments laboratory in Irvine, CA for physicians submitting prostate tissue samples directly or via its exclusive co-marketing partner, PLUS Diagnostics (Union, NJ).

"As many as one in four men could be misdiagnosed due to limitations with current prostate biopsy procedures, commonly described as 'sampling error.' As a consequence, the standard of care for men with persistently high-risk factors, but no evidence of prostate cancer in a biopsy, is limited to continued surveillance and repeat biopsies, often on prostate cancer-free men. The ConfirmMDx for Prostate Cancer test detects epigenetic changes associated with the presence or absence of prostate cancer," explained Wim van Crienkinge, PhD, of MDxHealth.

More information is available at the booths of MDxHealth and PLUS Diagnostics at this week’s AUA annual meeting (booths 3831 and 3923, respectively).

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