ConfirmMDx(TM) is a New Test for Prostate Cancer

May 16, 2012 by  
Filed under Prostate Cancer News

Many men over the years have been misdiagnosed of prostate cancer because of the limitations in the procedures carried out by the urologists. They could be subjected to different types of repeated tests that may even be unnecessary.

To address this problem, MDxHealth, a molecular diagnostic company has launched a new test known as ConfirmMDx(TM). This is a breakthrough test that can help urologists to carry out    accurate diagnosis of prostate cancer.

This new test and its launch is a result of many years of extensive research and development by the company as confirmed by the Chief Scientific Officer of MDxHealth. Here are more details on this new novel prostate cancer test:

MDxHealth SA (nyse euronext:MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the launch of ConfirmMDx(TM) for Prostate Cancer, a novel test that helps urologists distinguish patients who have a true-negative prostate biopsy from those who may have occult cancer. Testing will be performed in MDxHealth’s state-of-the-art Irvine-based CLIA laboratory for physicians submitting prostate tissue samples directly or via its exclusive co-marketing partner PLUS Diagnostics.

“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 Prof Dr. Wim van Crienkinge, Chief Scientific Officer of MDxHealth.

“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,” said Dr. Jan Groen, CEO of MDxHealth. 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.”

About ConfirmMDx for Prostate Cancer

Over 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. Click here to read the full article.

With this launch by MDxHealth, it is indeed good news for prostate cancer victims and urologists. The stress and pains of having to undergo repeated biopsies that are often painful are avoided. The company is renowned for the manufacture of advanced epigenetic tests for cancer assessement, it is hoped that this new test will really in transforming cancer diagnoses in men. In addition, we expect that men will not have above average diagnosis and care for their prostate cancer.

So, health care providers should look into this new novel test and see it can now be prescribed as a standard diagnostic tool to complement other known tools.

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