DIAGNOSTICS
anticipated results
By the end of the Phase I, we will have developed a lateral flow assay that identifies the presence of QSOX1-L urine samples. We expect QSOX1-L to correlate strongly with malignancy, since we have discovered it in the blood of BC patients. The sensitivity and specificity will be determined on a total of 100 preserved urine samples from people with BC at different stages and 100 donors without malignancy. This prototype device will serve as the basis for continued development in the Phase II. An assessment of the performance will be reviewed in consultation with key opinion leaders including clinicians, e.g. Dr. Ho, Mayo Clinic Scottsdale, AZ. Based on this feedback, a plan for Phase II development will be proposed.
By the end of the Phase I, we will have developed a lateral flow assay that identifies the presence of QSOX1-L urine samples. We expect QSOX1-L to correlate strongly with malignancy, since we have discovered it in the blood of BC patients. The sensitivity and specificity will be determined on a total of 100 preserved urine samples from people with BC at different stages and 100 donors without malignancy. This prototype device will serve as the basis for continued development in the Phase II. An assessment of the performance will be reviewed in consultation with key opinion leaders including clinicians, e.g. Dr. Ho, Mayo Clinic Scottsdale, AZ. Based on this feedback, a plan for Phase II development will be proposed.
