NewStem files with FDA, EMA for tumor mutation software

2019 10 16 20 31 7121 Cancer Cells Prostate 400

NewStem has filed pre-submission regulatory documents with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its NewStem software diagnostic device (NSDD) for detecting the presence of mutations in tumors.

NSDD is based on NewStem's bioplatform for genome-wide screening based on proprietary haploid human embryonic stem cells technology. NSDD is designed to inform oncologists about the presence of tumor mutations that may confer resistance to some anticancer therapies.

Drug resistance is regarded as the key reason for cancer mortality in patients treated with traditional chemotherapy or novel targeted therapies. The information generated by NSDD will guide oncologists in selecting treatment regimens for patients, according to NewStem.

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