NEW YORK (GenomeWeb News) – MDxHealth today announced New York has certified the company's prostate cancer test, allowing MDxHealth to offer the test to residents in the state.
The company can now offer the ConfirmMDx test in all 50 states in the US. The epigenetics-based test, which was launched in May 2012, uses tissue obtained from a previous negative prostate biopsy to differentiate patients with true negative results from those who are at high risk for missed cancer.
"This licensure opens one of our largest potential domestic markets within the US, with an estimated 65,000 prostate biopsy procedures performed annually," MDxHealth CEO Jan Groen said in a statement. The approval, he added, "completes our state licensing requirements and allows us to fully execute on our US commercialization strategy for this clinically significant prostate cancer test."
The company said a few weeks ago that it raised $23.6 million in a private placement to support and scale up its US CLIA laboratory and US-based sales and marketing, among other things.