Nuvera Biosciences has reported positive results of a blinded validation study of its breast cancer assay for taxane chemotherapy response.
The results of the blinded study support the findings of a separate multicenter validation study of the same assay.
In the multi-site study eligible patients received adjuvant chemotherapy with sequential anthracyline and either docetaxel or paclitaxel and had at least 3 years of follow-up.
The study’s primary endpoints are distant relapse-free survival (DRFS) and absolute risk reduction (ARR) at 3 years of follow up.
The study authors conclude that in interim analysis, assay prediction of treatment sensitivity was associated with improved 3-yr-DRFS following adjuvant taxane-chemotherapy or combined chemo- and endocrine therapy.
Nuvera Biosciences Technology founder and VP Christos Hatzis said they are looking forward to making this chemotherapy predictor test to guide therapy selection in newly diagnosed women with invasive breast cancer.
Nuvera plans to continue the development of its breast cancer assays for chemotherapy and endocrine therapy response in a CLIA-certified laboratory and to work towards meeting regulatory requirements for launch.