Diagnostics company opens new facility to scale up production of IsoPSA test for prostate cancer

Cleveland Diagnostics has opened a new state-of-the-art facility to help meet growing demand for testing and production of their IsoPSA test for prostate cancer, the company announced in a news release.¹

The IsoPSA test was recently included in the National Comprehensive Cancer Network Prostate Cancer guidelines for early detection of the disease.

Earlier this year, Cleveland Diagnostics partnered with Quest Diagnostics to utilize Quest’s national service and logistics operations to help expand access to the IsoPSA test. The expansion of a new facility will further build on efforts to meet growing demand for the novel blood-based test, according to Cleveland Diagnostics.

The new space, based out of Cleveland, Ohio, includes a larger clinical laboratory for IsoPSA testing, labs for research and development, administrative offices, and manufacturing spaces for future production and distribution of in vitro diagnostic kits.

“Transforming cancer diagnostics is no small feat, but we are well positioned to contribute to this important mission. This new facility represents our team’s commitment to advancing the science of early cancer detection through research, development, and distribution. As we continue to grow, this new space will be vital in making accurate and affordable diagnostic technology accessible to all patients, not only in prostate cancer but in other cancers as well,” said Arnon Chait, PhD, in the news release of the announcement. Chait is the president and CEO of Cleveland Diagnostics.

The IsoPSA test is a non-invasive, blood-based test used prior to an initial biopsy or after a negative biopsy to assess the likelihood that a patient has high-grade prostate cancer. The test was recently included in the National Comprehensive Cancer Network Prostate Cancer guidelines for early detection of the disease.²

The utility of IsoPSA was assessed in a real-world validation study published in Urology Practice.³ The study included 734 patients across 38 community-based and academic sites withing the Cleveland Clinic health system who were age 50 years or older, had a total serum prostate-specific antigen (PSA) level of 4 ng/mL or greater and less than 100 ng/mL, and no history of prostate cancer.

Data from the study showed that IsoPSA led to a 55% (284 vs 638) net reduction in prostate biopsy recommendations among men with total PSA level of 4 ng/mL or higher. The test also led to a 9% reduction in MRI imaging recommendations.

Investigators in the study also observed a high concordance between physician recommendations and IsoPSA test results, with 87% of patients who had an IsoPSA index above the threshold receiving a recommendation for biopsy, and 92% of patients who had an IsoPSA index below the threshold not receiving a recommendation for biopsy.

IsoPSA currently has an FDA Breakthrough Therapy designation and is pending FDA premarket approval.

References

1. Cleveland Diagnostics opens new facility amid growing demand for IsoPSA test. News release. Cleveland Diagnostics. June 28, 2023. Accessed June 29, 2023. https://www.businesswire.com/news/home/20230628404153/en/Cleveland-Diagnostics-Opens-New-Facility-Amid-Growing-Demand-for-IsoPSA%C2%AE-Test

2. Cleveland Diagnostics announces inclusion of IsoPSA in National Comprehensive Cancer Network guidelines for prostate cancer early detection. News release. Cleveland Diagnostics. May 11, 2022. Accessed June 29, 2023. https://www.businesswire.com/news/home/20220511005019/en/Cleveland-Diagnostics-Announces-Inclusion-of-IsoPSA%C2%AE-in-National-Comprehensive-Cancer-Network%C2%AE-Guidelines-for-Prostate-Cancer-Early-Detection

3. Scovell JM, Hettel D, Abouassaly R, et al. IsoPSA reduces provider recommendations for biopsy and magnetic resonance imaging in men with total prostate specific antigen ≥4 ng/ml: A real-world observational clinical utility study. Urol Pract. 2022;9(2):173-180. doi:10.1097/UPJ.0000000000000291