Dr. David Samadi, a recognized expert in robotic prostate cancer surgery who runs the David Samadi Prostate Cancer Center in New York, has announced that he supports the use of the diagnostic test ConfirmMDx as means to diagnose, or rule out, prostate cancer.
“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,” Dr. Samadi, chief of Robotic Surgery at Lenox Hill Hospital and a professor of Urology at Hofstra North Shore-LIJ School of Medicine, said in a press release.
ConfirmMDx was developed by MDx Health to address many of the problems associated with traditional prostate screening. The company previously presented data in two abstracts showing that the ConfirmMDx solution might be superior to standard approaches.
Data recently presented at the Genitourinary Cancers Symposium in San Francisco, California, a meeting organized by the American Society of Clinical Oncology, showed that the ConfirmMDx test could identify cancerous tissue in biopsies that initially were labeled cancer-free. The test could also distinguish between more aggressive and idle forms of tumors.
Traditional testing, employing a method called transurethral ultrasound biopsy, makes use of 10–12 needle biopsy cores and, in total, samples about 1 percent of the prostate. One result is that men can receive false negative reports, increasing their risk of developing undetected prostate cancer.
When a negative result is reported, the current procedure employs repeated biopsies to minimize the risk of cancer going undetected, exposing men who might never develop cancer to repetitive biopsies and screening procedures that could be associated with complications.
ConfirmMDx, in contrast, detects epigenetic changes in tissue going through a cancerization process at the DNA level. These epigenetic changes can be spotted in samples that have a normal appearance under the microscope.
The method is intended to aid urologists both by ruling out cancer-free men, who might otherwise be put through repeated biopsies, and by confirming cancer in men who had received a false negative biopsy result.
MDx Health, based in Irvine, California, specializes in the development of next generation epigenetics-based cancer tests, and ConfirmMDx is the company’s flagship product.