Dive Brief:

• FDA has granted breakthrough device designation to Cleveland Diagnostics' prostate cancer test, the company said Wednesday.

• The blood-based diagnostic is designed to improve on traditional prostate-specific antigen (PSA) tests by evaluating structural changes to the PSA protein, rather than simply measuring the level of the biomarker.

• Cleveland Diagnostics has already run prospective clinical trials of the diagnostic, putting it in a position to potentially gain FDA clearance for the test next year.

Dive Insight:

PSA is a flawed biomarker. The protein is found at elevated levels in some patients with prostate cancer. However, inflammation and infection can also cause PSA levels to rise to levels associated with prostate cancer. Further complicating the situation, PSA levels remain low in some prostate cancer patients.

Faced with an elevated PSA result, a physician may advise the patient to undergo a transrectal biopsy to assess whether they have cancer. Because some of the PSA results will be false positives, the American Urological Association guidelines warn PSA screening can result in "substantial harm" related to the side effects of unnecessary diagnostic biopsies and subsequent treatments. 

Cleveland Diagnostics developed a test to look for structural changes to PSA that are linked to cancer mutations with the goal of cutting down unnecessary biopsies. 

In a prospective study of 271 men, use of Cleveland Diagnostics' IsoPSA was associated with a 43% reduction in the number of unnecessary biopsies.

In an earlier study, researchers linked IsoPSA to either a 45% or 48% reduction in the false-positive rate, depending on whether the cutoff was selected to recommend biopsy or identify people at low risk of high-grade disease.

Armed with the results, Cleveland Diagnostics is gearing up to bring its test to market. The company aims to secure FDA clearance to market the test in the U.S. next year.

The FDA breakthrough status could support that goal by positioning Cleveland Diagnostics to receive additional input from the agency and an accelerated review once it makes its submission.