News — Branford, Connecticut — Wren Laboratories, a leader in molecular diagnostics, is proud to announce that its breakthrough liquid biopsy test, PROSTest™, has been approved by the New York State Department of Health Clinical Laboratory Evaluation Program (NYSDOH-CLEP). This approval marks a major advancement in the early detection and monitoring of prostate cancer, with far-reaching implications for men’s health.
Backed by a portfolio of over 150 international patents, Wren Laboratories is the global leader in mRNA-based molecular diagnostics, pioneering a new era of precision testing for cancer and other diseases. The approval of PROSTest™ solidifies the company's position at the forefront of non-invasive, clinically actionable diagnostic innovation.
PROSTest™ Key Highlights:
- 鉁� 92.7% overall accuracy, with 94.0% sensitivity to detect prostate cancer and 90.9% specificity to rule out benign conditions like BPH.
- 鉁� Significantly outperforms PSA testing in both detection and therapeutic monitoring.
- 鉁� 94% sensitivity for detecting minimal residual disease (MRD) and recurrence — compared to only 79% for Gallium-PET scans.
- 鉁� Requires only 1 mL of blood, offering a simple and non-invasive alternative to painful and often unnecessary biopsies.
Addressing a Critical Need in Men’s Health
Each year, more than 1 million men in the U.S. undergo prostate biopsies prompted by elevated PSA levels — yet up to 80% of these procedures reveal no clinically significant cancer. PROSTest™ offers a smarter, more accurate diagnostic pathway, reducing unnecessary procedures, associated risks, and healthcare costs.
“This is a major milestone in prostate cancer diagnostics,” said Dr. Abdel Halim, CEO and Chief Scientific Officer at Wren Laboratories. “PROSTest™ provides the precision that clinicians and patients have been waiting for — and we’re especially proud of its potential to reduce disparities and improve outcomes in the communities that need it most.”
Focusing on High-Risk Populations
Prostate cancer disproportionately affects African American men, who are twice as likely to die from the disease, and military veterans, who face higher exposure to environmental risk factors. Importantly, PROSTest™ has been shown to perform equally well in both African American and Caucasian populations, offering a more equitable and consistent diagnostic tool across diverse patient groups.
“Too many veterans face aggressive prostate cancer without access to cutting-edge diagnostics,” said Mike Crosby, Founder and CEO of Veterans Prostate Cancer Awareness Inc. “The approval of PROSTest™ is a game-changer — a reliable, non-invasive test that gives our veterans and all men a better chance at early detection and effective treatment. It’s a huge step forward for men’s health.”
By delivering high accuracy from a simple blood draw, PROSTest™ has the potential to transform care for underserved and high-risk communities, helping detect cancer earlier, reduce overtreatment, and enable more personalized care strategies.
“This test represents the future of prostate cancer care,” said Dr. Mark Kidd, Laboratory and Scientific Director at Wren Laboratories. “We’re committed to making diagnostics more precise, less invasive, and more equitable for all men.”
Now approved under CLIA, CAP, and NYSDOH, PROSTest™ is available for clinical use and research partnerships nationwide.
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