FDA approves IsoPSA diagnostic test to improve prostate biopsy decision-making

The U.S. Food and Drug Administration has approved Cleveland Diagnostics’ IsoPSA in vitro diagnostic kit, giving physicians a new blood-based tool to help determine whether men 50 and older with elevated PSA levels should undergo a prostate biopsy.

The approval, granted through the agency’s Premarket Approval pathway, is supported by results from a large prospective clinical study at 14 U.S. sites as well as additional analytical validation data, the company said.

“FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable,” said Arnon Chait, PhD, the company’s president and CEO.

IsoPSA is designed to address longstanding challenges with prostate cancer detection. Although more than one million men undergo prostate biopsies in the U.S. each year, as many as 75% of those procedures do not reveal high-grade disease. That gap exposes patients to unnecessary invasive procedures, added costs and emotional stress, according to the company. By examining protein biomarkers at a structural level, IsoPSA aims to offer a more accurate assessment of cancer risk.

“As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing,” said Aaron Berger, MD. “IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence.”

Eric Klein, MD, emeritus chair of the Glickman Urological & Kidney Institute at Cleveland Clinic, said the approval “underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer.”

Recent advances in prostate cancer diagnostics and risk stratification

Prostate cancer diagnostics has undergone rapid transformation in recent years, driven by new approaches aimed at reducing unnecessary biopsies and improving early detection of clinically significant disease. One of the most prominent areas of progress involves biomarker refinement. Researchers are increasingly developing assays that move beyond simple antigen measurement to capture more nuanced biological signals. These include tests that evaluate molecular changes, such as protein isoforms, genomic markers or epigenetic patterns, which can help distinguish aggressive cancers from indolent conditions that may not require immediate intervention.

Imaging technologies have also advanced significantly. Multi-parametric MRI has become an important tool in pre-biopsy evaluation, offering improved visualization of suspicious lesions and enabling more targeted sampling. This shift toward imaging-guided assessment has reduced reliance on systematic biopsies, which historically risked missing significant tumors or over-sampling benign tissue. Alongside MRI, newer tracers used in PET imaging have expanded clinicians’ ability to identify cancer spread earlier and with greater precision.

Risk-stratification models are gaining sophistication as well. These tools integrate clinical factors—such as age, family history and PSA kinetics—with imaging findings and biomarker data to provide a more personalized assessment of cancer likelihood. The goal is to better inform decisions regarding biopsy, surveillance or treatment. As machine-learning techniques evolve, some researchers are leveraging algorithms to analyze patterns across large datasets, potentially improving prediction accuracy beyond traditional methods.

Additionally, minimally invasive sampling techniques are being studied as alternatives to conventional transrectal biopsies. Transperineal approaches, for example, may help lower infection risk and improve access to certain regions of the prostate. Meanwhile, advancements in liquid biopsy research are offering early glimpses into future diagnostic options that may rely on circulating tumor cells or DNA fragments to detect cancer activity.

Collectively, these developments reflect a broader shift toward precision diagnostics—aiming to identify dangerous cancers earlier while sparing patients from procedures unlikely to provide benefit.