Development and evaluation of the MiCheck® Prostate test for clinically significant prostate cancer

Area of Science:

• Oncology
• Biochemistry
• Clinical Diagnostics

Background:

• Clinical need exists to identify patients with elevated Prostate-Specific Antigen (PSA) who require prostate biopsy for clinically significant prostate cancer (CSCaP).
• Previous development of the MiCheck® Test for CSCaP.
• Further development and integration of the MiCheck® Test with the Roche Cobas standard clinical chemistry analyzer.

Purpose of the Study:

• Adapt the MiCheck® Prostate test for use on a standard clinical chemistry analyzer.
• Characterize the test's performance using samples from the MiCheck-01 clinical trial.

Main Methods:

• Utilized 358 patient samples from the MiCheck-01 US clinical trial (46 controls, 137 non-CaP, 62 non-CSCaP, 113 CSCaP).
• Measured serum analyte concentrations for growth factors using Luminex-based kits.
• Examined analytes measurable by standard chemistry analyzers for algorithm development.
• Re-measured samples using a Roche Cobas analyzer for final algorithm development.

Main Results:

• Developed a logistic regression model incorporating PSA, %free PSA, Digital Rectal Exam (DRE), and Human Epididymal Protein 4 (HE4).
• Achieved an Area Under the Curve (AUC) of 0.85, with 95% sensitivity and 50% specificity for differentiating CSCaP.
• Demonstrated potential to avoid up to 50% of unnecessary biopsies, with minimal delay in diagnosing high-grade cancers.

Conclusions:

• The MiCheck® Prostate test effectively identifies CSCaP with high sensitivity and negative predictive value (NPV).
• The test is adaptable for clinical laboratories using the Roche Cobas analyzer.
• The MiCheck® Prostate test can aid in reducing unnecessary prostate biopsies while minimizing diagnostic delays.