pca-tx

Product Description

A diagnostic test kit quantitatively measures the expression levels of a panel of prostate cancer risk-associated biomarkers in patient urine sample or biopsy tissue sample to distinguish high-risk and aggressive prostate cancer needing immediate treatment from low-risk and indolent prostate cancer needing only surveillance

Function and Applications

  • A prostate cancer diagnostic test: can accurately stratify patients based on their cancer risk and aggressiveness and determine which patient needs treatment and which patient needs “watchful wait”
  • A prostate cancer progression surveillance test: can monitor prostate cancer progression and aggressiveness
  • Prevent both “under-treatment” and “over-treatment”

Testing Mechanism

  • Detection of a panel of prostate cancer risk-associated biomarkers that are differentially expressed in high-risk and aggressive prostate cancer cells as compared to low-risk and indolent prostate cancer cells
  • Prostate cancer cells dissociate from prostate gland and are released into urine, so prostate cancer-specific biomarkers in cancer cells can be detected in the urine sample

Detection Method

Using multiplex real-time quantitative RT-PCR to measure gene expression levels of prostate cancer risk-associated biomarkers and the diagnosis is made with our proprietary data analysis algorithm

Testing Platform

Test is run on any real time PCR machine, can be performed in most clinical testing labs.

Clinical Study Results

In one study with 144 patient specimens, the test has:
Sensitivity=90.28%, Specificity=93.33%, AUC=0.950, P<0.0001

In a different study with 244 patient specimens, the test has:
Sensitivity=93.93%, Specificity=90.00%, AUC=0.972, P<0.0001