IsoPSA™

The IsoPSA™ assay is currently involved in ongoing multi-center prospective studies. Results from the studies were published in tier 1 journals, including in European Urology and Journal of Urology.

The IsoPSA™ assay is not commercially available in the USA. It is expected to become available in Q4/2019, and nationally available following approval/clearance by the FDA in 2020.

Why IsoPSA™

Prostate-specific antigen, the current gold standard in prostate cancer detection, is distinct from virtually all other cancer biomarkers because of its almost exclusive specificity to the prostate, allowing direct assessment of physiological conditions in the gland with a simple blood test. Unfortunately, PSA is tissue- but not cancer-specific, and overdiagnosis and overtreatment of PSA-detected, biologically insignificant cancers are widely recognized as key limitations in its clinical utility.

IsoPSA™ Performance - Preliminary Study

An interim analysis of our multi-center prospective pilot study led by Eric Klein, MD, is provided below:

IsoPSAPerformance

Table 1. Performance metrics vs. PSA at selected cutoff risk probability values.

 

Figure 1A. ROC for PCa vs. no cancer
(ROC of the model:  Solid line = IsoPSA; dotted line = Standard PSA)

 
 

Figure 1B. ROC for High Grade PCa vs. low grade cancer/benign histology
(ROC of the model:  Solid line = IsoPSA; dotted line = Standard PSA)

 
 

IsoPSA™ Performance - Validation Study

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Economic & Financial Impact

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Future Research Focus

  • Active surveillance: personalized diagnostics monitoring for progression of patients identified with low-grade prostate cancer

  • Screening: Direct replacement of PSA with IsoPSA in the primary care physician environment

 

Any clinical researchers interested in learning more about the ongoing clinical study should contact us at info@cleveland-diagnostics.com.