Each year, in the United States, more than 650,000 men receive a negative prostate biopsy result, with around 25-35% of these results being false negative. However, a new prostate cancer test has been launched by MdxHealth. The test – ConfirmMDx™ for Prostate Cancer – will help physicians identify which men have a true-negative prostate biopsy from those who may have occult cancer.

Professor Dr. Wim van Crienkinge, Chief Scientific Office at MDxHealth, said:

“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.”

Dr. Jan Groen, CEO of MDxHealth explained:

“The launch of ConfirmMDx for Prostate Cancer represents the culmination of extensive research and development efforts and demonstrates the commitment of the MDxHealth team to deliver on its new commercial strategy. MDxHealth is uniquely positioned with its portfolio of epigenetic assays to capitalize on the realization of true personalized medicine, improving patient care, while reducing healthcare costs.”

At present, prostate biopsies only sample less than 1% of a man’s prostate – collecting 10-12 needle biopsy cores on average. As a result men are often left at risk of occult cancer, leading to a high rate of subsequent biopsies.

The new test – which can detect an epigenetic field effect or “halo” linked with the cancerization process at the DNA level in cells adjacent to cancer foci – will help physicians distinguish men who have true-negative biopsy from men at risk for occult cancer.

This molecular “halo” surrounding a cancer lesion can be present even though its appearance is normal under the microscope. As a result the new test will help urologists distinguish which men are able to do without unnecessary repeat biopsies.

Written By Grace Rattue