A Test for prostate cancer – MiCheck^® Prostate: quick, non- invasive, highly sensitive and specific

Intended Purpose

MiCheck^® Prostate is an algorithm that combines the testing results of three serum immunoassays with the patient’s clinical factors to calculate a MiCheck^® Prostate Percentage Risk Score, provides an indication of the likelihood of the presence of aggressive (i.e. clinically significant) prostate cancer (AgCaP) and is called the MiCheck^® %Risk of AgCaP. The clinical factors can be included in the algorithm are the patient’s age, result from digital rectal examination (DRE) or a multiparametric MRI (mpMRI)-derived prostate volume result.

MiCheck^® Prostate is for male subjects being considered by physicians for a prostate biopsy. It is intended to supplement and not replace the significance of other clinical factors or test results which collectively assist the clinical judgement and experience of the urologist in the decision about whether or not to proceed to prostate biopsy. Prostate biopsy is required for the diagnosis of cancer.

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