Next-gen prostate cancer test maker Cleveland Diagnostics rocks to $75M fundraising

Cleveland Diagnostics, maker of a prostate cancer screening test, has raised more than $75 million in growth capital funds to expand its approach to additional tumors. 

The financing was led by Novo Holdings, which manages the Novo Nordisk Foundation and includes backing from Cleveland Diagnostics’ previous investors in addition to a credit facility offered by Symbiotic Capital.

The Cleveland Clinic portfolio company said the proceeds will help it meet rising demand for its currently marketed IsoPSA test, a next-generation prostate-specific antigen assay that aims to determine whether rising PSA levels in the blood are benign or connected directly to cancer, with the goal of ruling out unnecessary tissue biopsies.

IsoPSA previously received a breakthrough designation from the FDA in 2019 for its ability to measure and analyze different forms of PSA proteins and began its commercial launch in 2020 through the Cleveland Clinic’s Glickman Urological and Kidney Institute. 

In February 2023, the company signed a deal with Quest Diagnostics to offer IsoPSA nationwide. Cleveland Diagnostics estimates that prostate cancer accounted for about 288,000 new diagnoses last year, as well as more than 34,000 deaths in the U.S.

Now Cleveland Diagnostics has set its sights beyond prostate cancer, with additional oncology indications and “key clinical and regulatory milestones in 2024,” according to co-founder and CEO Arnon Chait. The cash will also boost IsoPSA’s geographic reach in urology, the company said. 

“The company’s differentiated blood-based approach presents an opportunity to further improve diagnostics for other cancers and diseases,” said Novo Holdings partner Noel Jee, who will join Cleveland Diagnostics’ board of directors.