The following is a summary of “Development and evaluation of the MiCheck® Prostate test for clinically significant prostate cancer,” published in the November 2023  issue of Urology by Shore, et al.

Patients with a high PSA level need to be found because they may have clinically significant prostate cancer (CSCaP) and would benefit from a prostate biopsy. They have already talked about how the MiCheck® Test for clinically significant prostate cancer was created. Here, they talk about how MiCheck has improved and added the Roche Cobas standard clinical chemistry tester. For a study, researchers sought to improve the MiCheck® Prostate test to be done with a regular clinical chemistry analyzer and describe how well it works using the MiCheck-01 clinical study sample set. 

For the MiCheck® Prostate test, samples from about 358 patients in the MiCheck-01 US clinical study were used. 46 were controls, 137 were non-CaP, 62 were non-CSCaP, and 113 were CSCaP. They used custom-made Luminex-based R&D Systems multi-analyte kits to determine how much cellular growth factors were in the serum. Researchers looked at different chemicals that can be tested with regular chemistry equipment to see if they could help make a program that is very good at finding clinically significant prostate cancer. After that, samples were measured again with a Roche Cobas analyzer to make the final formula. They used logistic regression modeling and Monte Carlo cross-validation to find Human Epidydimal Protein 4 (HE4) as a marker that could make the method 95% more specific. The readings of the analytes from the Cobas analyzer were used to make the final model. The PSA, %free PSA, DRE, and HE4 that made up the MiCheck® logistic regression model were created. 

The model could tell the difference between cancer that was clinically significant, no cancer, and cancer that was not clinically significant with an AUC of 0.85, a sensitivity of 95%, and a specificity of 50%. It was shown that using the MiCheck® test on all 358 patients from the MiCheck-01 study showed that up to 50% of needless biopsies could be avoided. This meant that only 5.3% of Gleason Score (GS) 3+4 cancers, 1.8% of GS 4+3 cancers, and no GS 8–10 cancers would be diagnosed later. With a high sensitivity and negative predictive value (NPV), the MiCheck® Prostate test can find clinically significant prostate cancer. With a Roche Cobas clinical chemistry monitor, it can be done in a clinical laboratory. A small number of people may have a delayed diagnosis because of the MiCheck® Prostate test, but it could help cut down on needless prostate surgeries.

Source: sciencedirect.com/science/article/abs/pii/S107814392300265X