Predictus Biosciences has developed a novel IHC test, P-topoI-Dx, that specifically immunostains phosphorylated topoI-S10. The test can stratify the responder and non-responder patient populations for topoI inhibitors using an FFPE slide.
Clinical Validation of P-topoI-Dx
CRC and GC (n=282) formalin-Fixed Paraffin-Embedded (FFPE) tissue from patients treated with irinotecan were immunostained and the percent of positive nuclei was quantitatively analyzed and statistically analyzed as shown in Figure 2 and 3. The sensitivity, specificity, positive and negative predictive value of P-topoI-Dx is similar or better than the FDA-approved IHC-based predictive biomarker used in clinical oncology (Table).