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NewStem Files FDA De Novo Submission, Gets CE Mark for Stem Cell Mutational Analysis Software

NEW YORK – NewStem said Monday that it filed a de novo presubmission to the US Food and Drug Administration and has obtained a CE IVD mark for its NewStem Software Diagnostic Device (NSDD).

The CE mark will allow NewStem to use and sell the product in Germany and in European countries where the German registration is valid, a company spokesperson said.

NSDD is a bioinformatics-based platform that screens human haploid embryonic stem cells for gene mutations involved in chemotherapy resistance. The platform is designed to assist oncologists in choosing which treatment regime to use for a patient.

NewStem began as a spinout from the Hebrew University of Jerusalem with $2 million in seed financing in 2018 from NovelStem International, and a commitment for $2 million more. Last year, NewStem partnered with a biopharma company to apply its platform to the discovery of new cancer targets and development of cancer immunotherapies.

NewStem uses a proprietary method for inducing human egg cells to divide, resulting in self-renewing haploid human embryonic stem cells (ESCs). According to NewStem, haploid human ESCs readily differentiate into cells from all three embryonic germ layers and offer an alternative more effective than diploid cells for screening recessive mutations, which can be canceled by a wild-type allele. Loss-of-function mutations can be screened for positive or negative effects by subjecting libraries of mutant haploid human ESCs to various treatments. The platform can also screen diseased cells for mutations that result in reversion to normal function.

Under the new regulatory filings, the platform will be used to screen for cancer drug resistance in traditional chemotherapeutics or targeted treatments.

NewStem is currently raising a series A round of financing to expand its research and development activities. The company also graduated from the third funding cycle of the Illumina Accelerator in March.