FDA signals on quality
- The FDA approved IsoPSA, a blood‑based prostate cancer test, for men 50+ with elevated PSA. - Prospective study data reportedly showed IsoPSA outperformed total PSA and free PSA measures. - The agency also urged sponsors not to hide unfavourable trial results, reinforcing traceability and documentation expectations ( ).
The U.S. Food and Drug Administration has approved IsoPSA, a blood‑based in vitro diagnostic to help decide prostate biopsies in men aged 50 and older with elevated PSA. (businesswire.com) The approval was granted through the Premarket Approval (PMA) process and was announced by Cleveland Diagnostics on December 1, 2025. (businesswire.com) FDA reviewers relied on clinical evidence from a large, prospective multicenter study conducted across 14 U.S. sites that enrolled men ≥50 years with total PSA ≥4 ng/mL. (cancernetwork.com) The company and independent reporting say IsoPSA outperformed total PSA and percent‑free PSA for detecting high‑grade prostate cancer—AUC for high‑grade disease was 0.783 vs 0.672 (total PSA) and 0.724 (percent‑free PSA), P <.001. (cancernetwork.com) Cleveland Diagnostics noted more than 1 million prostate biopsies are performed in the U.S. each year and that up to 75% of those biopsies are negative for high‑grade disease. (businesswire.com) IsoPSA measures cancer‑specific structural variants of the prostate‑specific antigen protein using the company’s IsoClear platform, a structure‑focused approach rather than a concentration‑only PSA test. (cancernetwork.com) Arnon Chait, PhD, president and CEO of Cleveland Diagnostics, said FDA approval “marks a significant milestone” and the company will focus on commercial rollout and expanding access. (businesswire.com) Separately, the FDA on April 13, 2026 reminded more than 2,200 medical product companies and researchers to submit required clinical trial results information to ClinicalTrials.gov. (fda.gov) The agency’s internal analysis found 29.6% of studies likely subject to mandatory reporting had no results posted, and on March 30, 2026 the FDA sent messages tied to more than 3,000 registered trials seeking voluntary compliance. (fda.gov) “Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community,” FDA Commissioner Marty Makary said in the agency release. (fda.gov) IsoPSA’s PMA approval sets the test on a commercial path while the FDA presses sponsors to make trial data traceable and public; Cleveland Diagnostics will now pursue clinical adoption as regulators push for greater transparency. (businesswire.com)
