New York, NY – (PR Newswire – January 11, 2016) – Dr. David Samadi is a world renowned prostate cancer surgeon and urologic oncologist in New York. He specializes in the treatment of prostate cancer, as well as other prostate conditions such as benign prostatic hyperplasia. Dr. Samadi supports new data from MDxHealth suggesting that the diagnostic test, ConfirmMDx, is useful for helping to diagnose or rule out prostate cancer.

MDxHealth has announced positive data from two abstracts showing the benefit of a new diagnostic test for prostate cancer called ConfirmMDx. MDxHealth is a company that specializes in the development of next generation epigenetic prostate cancer tests to help rule out false-negative biopsy results and prevent unnecessary repeat biopsies.

According to Dr. David Samadi at the David Samadi Prostate Cancer Center in New York, “Every year, there are about one million men in the United States who receive biopsy results that are inconclusive. ConfirmMDx is a solution that meets this significant unmet need in men with prostate cancer. This helps us urologists help our patients prevent having to have unnecessary and repeat biopsies.”

The data was presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium last week in San Francisco, California. The data demonstrates the following:

·       ConfirmMDx test's ability to detect an epigenetic field effect associated with the presence of anterior-predominant tumors that was missed in a previous negative biopsy.

·       ConfirmMDx test's ability 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.

Every year, there are over 975,000 men are diagnosed with a negative prostate biopsy each year. About 25 to 35 of those men receive false-negative results. The traditional prostate biopsy procedure, called a trans-urethral ultrasound biopsy, consists of 10 to 12 needle biopsy cores. This method has also been known as a “blind biopsy” due to the fact that it only samples about 1 percent of a man's prostate. As a result, men often receive false-negatives or inconclusive results which puts men at risk for undetected prostate cancer. These men, which may include men who don’t even have prostate cancer, are often required to have repeat biopsies.

The ConfirmMDx for Prostate Cancer testing solution addresses false-negative biopsy concerns, helping urologists: 

·       “Rule-out” otherwise cancer-free men from undergoing unnecessary repeat biopsies and screening procedures, helping to reduce complications, patient anxiety and excessive healthcare expenses associated with these procedures.

·       “Rule-in” high-risk men with a previous negative biopsy result who may be harboring undetected cancer (false-negative biopsy result) and therefore may benefit from a repeat biopsy and potentially treatment.

The ConfirmMDx prostate cancer test works by being able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level. This "halo" around a cancer lesion can be present despite cells having a normal appearance under the microscope.

Other than ConfirmMDx, the MRI-guided prostate biopsy is the newest advancement in diagnosing prostate cancer. It is more specific than the traditional biopsy method, and thus detects prostate cancer more accurately and reduces the need for repeat biopsies. ConfirmMDx as well as the MRI-guided prostate biopsy are both offered at the David Samadi Prostate Cancer Center in New York. Both diagnostic tools are the latest in prostate cancer and can help patients receive a more accurate diagnosis.

Patients who are interested in learning more about ConfirmMDx, the MRI-guided prostate biopsy, or are newly diagnosed with prostate cancer can contact world renowned prostate cancer surgeon and urologic oncologist, Dr. David Samadi, for a phone consultation. Call 212.365.5000 to set up your consultation with Dr. Samadi.