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MDxHealth Posts Sharp Rise in Q3 Revenues

NEW YORK (GenomeWeb) – MDxHealth reported today that its third quarter revenues rose 122 percent, driven by a sharp increase in the number of payors issuing positive coverage decisions for its ConfirmMDx and SelectMDx prostate cancer tests.

For the three months ended Sept. 30, the Belgian molecular diagnostics company said revenues rose to $9.1 million from $4.1 million in Q3 2015.

"The sharp revenue growth has been driven by the strong increase in payor coverage for our lead product ConfirmMDx in the key US market. We anticipate continuing acceleration in the adoption of ConfirmMDx among payors and physicians, broadening availability to patients and preventing thousands of unnecessary and often painful biopsies," said MDxHealth CEO Jan Groen in a statement. "In doing so we expect our strong Q3 performance to continue into Q4."

The majority of payor coverage decisions came after ConfirmMDx was included in the US 2016 National Comprehensive Cancer Network (NCCN) Guidelines for prostate cancer screening. "Tests that improve specificity in the post-biopsy state — including 4Kscore, PHI, percent free PSA, PCA3, and ConfirmMDx — should be considered in patients thought to be higher risk despite a negative prostate biopsy," the NCCN guidelines now say.

The company has signed coverage deals for the test with 25 commercial health plans, including major payors such as Cigna, Highmark BCBS, Independence BC, and others. The company also received a positive coverage decision from Health Care Services Corporation after the quarter ended, marking the third instance of a Blue Cross Blue Shield Association licensee opting to cover ConfirmMDx, and adding five more BCBS plans that offer the test.

ConfirmMDx is also covered under the California Medical Assistance Program.

Groen added that the company has tested more than 2,000 men with its SelectMDx liquid biopsy test since its launch in March, and that nine health plans now cover the test, including Multiplan, America's Choice Provider Network, Fortified Provider Network, and Galaxy Health Network.

MDxHealth has also signed five distribution agreements for SelectMDx, including with Cerba HealthCare Belgium for France, Belgium, and Luxembourg; with Teva Pharmaceuticals for Israel; and with Uruguay-based biotechnology company SouthGenetics for Argentina, Bolivia, Chile, Columbia, Ecuador, Mexico, Peru, the Dominican Republic, Panama, Paraguay, Uruguay, and Venezuela.

The company's net loss for the quarter narrowed to $2.7 million from $4.8 million in the year-ago quarter.

MDxHealth ended the quarter with $15.2 million in cash and cash equivalents.

The company maintained its guidance for a 60 percent increase in projected 2016 revenues over its FY 2015 revenues of $17.6 million.