Confirmation of False or True Negative Prostate Biopsies

An irregular result from a digital rectal examination (DRE) and/or elevated prostate-specific antigen (PSA) level in the blood generally triggers referral to the urologist for a prostate biopsy procedure. In most cases, the results are negative for malignancy, which is clinically problematic because some of the patients continue to have abnormal PSA and DRE findings. In fact, about 40% of the negative results are false negatives.  An obvious concern with the use of histopathologic examination for identifying malignant disease is that this method relies on cell morphology rather than molecular indications. Because neoplasia and the potential cellular transformation to malignancy are based on alterations in gene function, changes in cell appearance occur relatively late in this process. In contrast, mitochondrial genome (mtgenome) mutations occur early in the transformation process .  Therefore, a molecular diagnostic assay that predicts a missed tumor in the existing prostate biopsy specimen is a significant breakthrough in prostate health which leads to more appropriate and effective treatment.

What is BIOPSY+™?

Using existing biopsy tissue, BIOPSY+™ is a molecular diagnostic assay capable of identifying false negatives by detecting underlying molecular alterations in normal appearing tissue, indicative of malignant transformation.  As a result, BIOPSY+™ will significantly reduce the false negative diagnosis of prostate cancer for men who have undergone a prostate needle biopsy. 

Value Proposition

• BIOPSY+™ is ‘patient friendly’ ….no need for additional tissue samples as the test relies on the original samples obtained for histopathological diagnosis.
• BIOPSY+™ is a low cost molecular diagnostic test…in terms of pathologist’s & physician’s time, as well as lab processing costs
• BIOPSY+™ is an all around top performer of all competing molecular diagnostic applications…in terms of sensitivity, specificity, and cost
  

External validation

BIOPSY+™ has been validated by the Biochemical Science Division of the National Institute of Standards and Technology (NIST) in association with the National Cancer Institute’s (NCI) Early Detection Research Network (EDRN).  The validated results confirm our findings and further reflect the high level of sensitivity and specificity of the results.