IsoPSA® Prostate Cancer Test Now Available in VA Healthcare Systems

The Department of Veterans Affairs (VA) adds Cleveland Diagnostics’ novel prostate cancer test to Federal Supply Schedule

Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, is announcing that its flagship IsoPSA^® test has been added to the VA Federal Supply Schedule Program. The blood-based test for prostate cancer will now be available from the company’s clinical laboratory to roughly 17 million living veterans, more than 9 million of whom actively seek care at VA healthcare facilities.

Approximately 15,000 men are diagnosed and treated for prostate cancer in the VA system each year. Military veterans are about twice as likely as civilians to be diagnosed with prostate cancer, and roughly 5 million men who seek VA healthcare fall within the standard screening age range of 50–70 years old. For those veterans, IsoPSA can now provide additional clarity about an elevated PSA result, helping clinicians more confidently guide next steps or follow-up procedures.

“IsoPSA can help us as urologists answer the often-asked question of, ‘Do I really need a biopsy?’ It is a more precise test compared to Total PSA or %Free PSA, which require the consideration of benign causes of an elevated PSA when deciding if a patient needs further work-up,” shared Dr. Mary Fakunle, Assistant Professor in the Department of Urology at Wake Forest University School of Medicine. “Because this test is specific to clinically significant prostate cancer, it can reduce the identification of subclinical prostate cancer that does not require immediate treatment. This is especially important for veterans with competing co-morbidities where low-grade prostate cancer is unlikely to have an impact on their overall health or lifespan and thus does not need to be found.”

The announcement comes during a critical growth period for Cleveland Diagnostics as it also continues to advance commercialization of its IsoPSA Assay kit, a blood-based prostate cancer test used to aid in prostate biopsy decision-making for men at or over 50 years of age with elevated PSA levels (4.0-10.0 ng/mL). The IsoPSA Assay kit was approved by the FDA in December 2025 and can be run in qualified clinical laboratories.

“It’s truly an honor to partner with the VA to bring IsoPSA to our country’s veterans,” said Michael Iskra, CEO of Cleveland Diagnostics. “The people who have given so much to serve our country deserve the most advanced diagnostic pathways available, and IsoPSA has the potential to benefit millions of veterans undergoing screening for prostate cancer through our ongoing commercialization efforts to ensure broad patient access to this important test.”

Prostate cancer is the second most common cancer in American men. More than one million prostate biopsies are performed each year in the U.S.; 75% are negative for high-grade disease. IsoPSA helps close this diagnostic gap, giving clinicians more accurate, protein structure-based risk assessment information to potentially avoid invasive procedures, unnecessary costs, and further anxiety.

The addition of IsoPSA to the VA’s Federal Supply Schedule is another milestone for Cleveland Diagnostics as it continues to scale the novel diagnostic. In addition to its relationship with the VA, a growing list of urologists, and commercial payors the company is also partnered with Quest Diagnostics where it offers the IsoPSA Test to clinics nationwide, further expanding patient access to aid in the diagnosis of high-grade prostate cancer.

For more information and company news, visit ClevelandDx.com.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics is a precision oncology company focused on changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform that enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy to execute tests within the clinical lab setting. Learn more at ClevelandDx.com and IsoPSA.com.

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Because [IsoPSA] is specific to clinically significant prostate cancer, it can reduce the identification of subclinical prostate cancer that does not require immediate treatment. - Dr. Mary Fakunle, Wake Forest University School of Medicine