Based on its recent analysis of the prostate cancer diagnostics market, Frost & Sullivan recognizes MDxHealth with the 2015 Global Frost & Sullivan Award for Technology Innovation. To advance molecular diagnostic tests for urological cancers, MDxHealth supplemented its prostate cancer test, ConfirmMDx, with a urine-based "liquid-biopsy" test called SelectMDx. These two solutions can significantly reduce the number of unnecessary biopsy procedures thereby eliminating needless pain, infection, and cost.
"The standard prostate cancer biopsy procedure is imprecise, evaluating less than 1 percent of the prostate, leaving close to one third of men at risk for undetected cancer which results in a high rate of repeat biopsies," said Frost & Sullivan Senior Industry Analyst Divyaa Ravishankar. "MDxHealth's ConfirmMDx and SelectMDx tests help urologists identify prostate cancer patients with much higher accuracy. While the SelectMDx test clarifies the requirement for a biopsy, the ConfirmMDx provides in-depth tissue analysis."
ConfirmMDx for Prostate Cancer, an epigenetic test, is MDxHealth's flagship product. Although prostate cancer lesions are frequently small, the tissue around the tumors is often altered at the genomic level. The ConfirmMDx test is used to analyze prostate tissue samples, previously interpreted as benign or normal, with epigenetic biomarkers, which identify DNA methylation changes associated with the presence of prostate cancer. Using the residual tissue from the previous biopsy, ConfirmMDx effectively expands the analysis to a larger region of the prostate to rule out the presence of cancer, thereby eliminating the need for repeat biopsies.
Cancer cells could be present in about 25 percent of the samples that pathologists previously identified as cancer-free, clearly demonstrating the medical need for ConfirmMDx. The test has a 96 percent negative predictive value to rule out aggressive prostate cancer. MDxHealth announced its recent partnership with SouthGenetics, Inc. that will allow it to expand its market share and offer the ConfirmMDx test in both Central and South America.
The SelectMDx for Prostate Cancer test was designed and validated to identify men with elevated prostate-specific antigens (PSA) who are at risk for aggressive prostate cancer. PSA screening measures the protein level in the blood, which can elevate due to a variety of factors, including benign prostate hyperplasia or even an infection. The urine-based SelectMDx test assesses prostate cancer-specific molecular RNA (mRNA), which give urologists a better idea of whether or not to perform a prostate biopsy.
"The company is expanding its diagnostic offerings into other urological applications as well, and has developed the urine-based "liquid biopsy" test called AssureMDx™ for Bladder Cancer test which is currently undergoing clinical validation trials. MDxHealth expects to release the test for clinical testing by the end of 2016," noted Ravishankar. "Overall, with a strong pipeline of products targeting different urological cancers, MDxHealth has altered the landscape of the cancer diagnostics market."
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