Skip to main content

New York Approves MDxHealth Prostate Cancer Test

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.

The Scan

Pfizer-BioNTech Seek Full Vaccine Approval

According to the New York Times, Pfizer and BioNTech are seeking full US Food and Drug Administration approval for their SARS-CoV-2 vaccine.

Viral Integration Study Critiqued

Science writes that a paper reporting that SARS-CoV-2 can occasionally integrate into the host genome is drawing criticism.

Giraffe Species Debate

The Scientist reports that a new analysis aiming to end the discussion of how many giraffe species there are has only continued it.

Science Papers Examine Factors Shaping SARS-CoV-2 Spread, Give Insight Into Bacterial Evolution

In Science this week: genomic analysis points to role of human behavior in SARS-CoV-2 spread, and more.