New Developments

MDxHealth Announces Results From the ConfirmMDx(TM) for Prostate Cancer Test  Studies Presented at the 2013 ASCO Genitourinary Cancers Symposium

IRVINE, CA, and LIEGE, BELGIUM–(Marketwire – Feb 18, 2013) -  MDxHealth  SA (EURONEXT BRUSSELS:MDXH), a leading molecular diagnostic company that develops  and commercializes epigenetic tests to support the diagnosis and treatment of  cancer patients, today announced the results of two studies of the ConfirmMDx™  for Prostate Cancer test presented at the ASCO Genitourinary Cancers Symposium  2013, February 14-16, Orlando, Florida, USA.

“These additional clinical studies add to our extensive body of peer-reviewed  evidence, clearly demonstrating the ability of ConfirmMDx for Prostate Cancer  test to provide valuable diagnostic information to support urologists in better  patient management,” said Jesse Savala, M.D.,  clinical pathologist and Medical Director at MDxHealth. “With the advances  being made in human epigenetics, we believe that DNA methylation-based tests  hold the promise to improve the diagnosis and subsequent treatment of cancer  patients.”

Studies clearly show that the ConfirmMDxfor  Prostate Cancer test provides very important personalized information that  cannot be achieved with traditional procedures:

  • In the Epigenetic Field Effect study in Histologically Benign Prostate  Biopsy Cores it was shown that GSTP1, APC and/or RASSF1 gene promoter methylation is more prevalent in  histologically benign cores from prostate cancer (PCa) patients diagnosed  with Gleason Score (GS) 7 PCa, as compared with low volume GS 6. This study  confirms previous findings in a larger cohort of subjects that these  “field effect” biomarkers can be useful for detecting cancer adjacent  to histologically negative biopsies and may be indicative of  occult aggressive PCa.
  • The multi-gene ConfirmMDx™ for Prostate Cancer test demonstrated  that epigenetic profiling is a significant predictor for PCa risk,  especially to identify those men who should (not) undergo a repeat biopsy  following a negative initial biopsy. An integrated risk management approach  that combines this epigenetic assay with other risk factors, most notably  histopathologic features of the cancer-negative initial biopsy, resulted in  an improved prediction for the presence of PCa with sensitivity and  negative predictive values of respectively 74% and 91%.

About ConfirmMDx for Prostate Cancer
Over  650,000 American men receive a negative prostate biopsy result each year; though  approximately25% of these men may still harbor occult prostate cancer. This  well-documented risk of undetected cancer, often with clinically significant  disease leads to a high rate of repeat biopsies with over 40% of men receiving  at least one repeat biopsy, and many receiving a 3rd and  4th biopsy. Today’s gold standard diagnostic approach is the prostate  biopsy procedure, collecting 10-12 needle core biopsy samples, however this  sampling represents less than 1% of a man’s prostate. ConfirmMDx for Prostate  Cancer is an epigenetic assay to help urologists distinguish patients who have a  true-negative biopsy from those at risk for occult cancer. The test is able to  detect an epigenetic field effect or “halo” resulting from oncogenic  processes 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. 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.

About MDxHealth
MDxHealth is a molecular diagnostics  company that develops and commercializes advanced epigenetic tests for cancer  assessment and the personalized treatment of patients. The company’s first  commercial product, the ConfirmMDx™ for Prostate Cancer test, has been shown to  help distinguish patients who have a true-negative biopsy from those who may  have occult cancer. MDxHealth helps to address a large and growing unmet medical  need for better cancer diagnosis and treatment information. The company has a  proprietary platform and a strong epigenetic product pipeline focused on the  development of products for brain and lung cancers. The company is based in  Irvine, California with a European headquarters in Liege, Belgium. For more  information visit MDxHealth website at

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An article which is focused on the current post-docetaxel strategies in the management of mCRPC.  In their introduction, the authors note that two pivotal trials (TAX 327 and Southwest Oncology Group (SWOG) trial)  examining docetaxel-based regimens were the first to demonstrate an overall survival benefit in patients with mCRPC.  In the years following, several different approaches were taken to build on the success of docetaxel in patients with mCRPC. One approach was to explore combinations of novel therapies with docetaxel. Unfortunately, to date, these studies have proven somewhat disappointing.

However, a second approach to the patient with mCRPC has been to explore the efficacy of novel therapies either before or after docetaxel therapy. These efforts have thus far proven to be more successful than explorations of combination therapy, according to the authors. They add that, to date, the bulk of progress has been made in the post-docetaxel space, in which agents such as cabazitaxel, abiraterone, MDV3100, and radium-223 have demonstrated statistically significant benefits in OS.

This article focuses on the current post-docetaxel strategies. The clinical data related to each agent is reviewed in detail in order to provide a framework with which to approach the docetaxel-refractory patient.  In their summary of the data on each agent, the authors note there is “considerable debate” on the optimal sequence of mCRPC therapies. This debate is not based on clinical trials but, instead, on inferences and various biases. Its suggested that no sequence of treatments can be recommended based on clinical trial data but, as mentioned in the article, both cabazitaxel and abiraterone are only approved in the post-docetaxel mCRPC patient.

Its also noted that prior to 2004 and the randomized docetaxel trials (TAX327 and SWOG 9916), no treatment had been demonstrated to improve overall survival in a large phase III trial. After 2004, the concept of the pre-docetaxel and post-docetaxel space has defined the regulatory and clinical approach to mCRPC. Its suggested that such a definition “is rational but not biologically based.”

Study IDs gene linked to inherited prostate cancer BIO SmartBrief                                                              

Research in the New England Journal of Medicine found that men with a mutation in the HOXB13 gene mutation are up to 20 times more likely to develop prostate cancer. The study could help determine which men need early screening. Researchers analyzed the DNA of 94 families and found the HOXB13 mutation was shared by four of them. A broader analysis showed the mutation was more common among men with a family history of the illness or early onset.

FDA OKs prostate cancer assay from Gen-Probe    Gen-Probe has secured FDA approval for PROGENSA PCA3, which is billed as the first molecular assay designed to help evaluate whether men who previously had negative prostate biopsies need to undergo a repeat biopsy.

Clot risk prods FDA to suspend testing of GTx prostate cancer drug    

The FDA suspended Phase II clinical trials of Capesaris, a drug candidate for advanced prostate cancer, after developer GTx reported an increased blood clot risk among patients who received at least 1,000 milligrams. GTx requested a meeting with the FDA to discuss the development program for Capesaris

Prostate Cancer Sexuality Survey
The respondents are very candid in this survey sharing their most inner thoughts and feelings.  To read the survey click here.

Furthering the prostate cancer screening debate (prostate cancer specific mortality and associated risks)
Screening for prostate cancer remains a contentious issue. As with other cancer screening programs, a key feature of the debate is verification of cancer-specific mortality reductions. Unfortunately the present evidence, two systematic reviews and six randomized controlled trials, have reported conflicting results.
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Game-Changing Research in Urology
Urology is such a diverse field that identifying the “top” advances in a given year is almost impossible. However, the following review describes some of the most significant milestones that will change the practice of urology and help shape future avenues for research…
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Top Five Regrets Of The Dying
For many years I worked in palliative care. My patients were those who had gone home to die. Some incredibly special times were shared. I was with them for the last three to twelve weeks of their lives. People grow a lot when they are faced with their own mortality. I learned never to underestimate someone’s capacity for growth. Some changes were phenomenal. Each experienced a variety of emotions, as expected, denial, fear, anger, remorse, more denial and eventually acceptance. Every single patient found their peace before they departed though, every one of them. When questioned about any regrets they had or anything they would do differently, common themes surfaced again and again. Here are the most common five…
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Treatment delay may be beneficial – The Vancouver Sun
“Men with low-risk prostate cancer may wait to see if their disease progresses before treating it, an independent panel of experts convened by the National Institutes of Health said Wednesday…
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Well done meat consumption may increase Prostate Cancer Risk  -  Research into the dietary habits of about a thousand men from the Cleveland area has found that a high consumption of meats, especially of red meat prepared by grilling, is positively associated with an increased risk of developing aggressive prostate cancer.  This particular study, which was led by Dr. John Witte of the University of California, San Francisco (UCSF), has a number of limitations, but it does add support to other investigations connecting meat consumption with cancer risk.