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MolecularMD Gets CE Mark for CDx Assay Used in Daiichi Sankyo Clinical Trial

NEW YORK (GenomeWeb) – Molecular diagnostics company MolecularMD announced today that it has received CE marking for a custom companion diagnostic it developed for a Daiichi Sankyo clinical trial.

The Phase II trial is testing a cancer therapy in Europe, MolecularMD said. The firm's assay is being used to select patients to participate.

"Identifying the precise subset of patients who may respond to our compound helps to fully assess its potential efficacy and safety profile," Antoine Yver, executive VP and global head of Daiichi Sankyo's oncology R&D, said in a statement.

The deal with Daiichi Sankyo is one of several similar agreements MolecularMD has signed with prominent biopharmaceutical companies, the firm added. "MolecularMD is entirely focused on accelerating development of precision oncology medicines. Our work with Daiichi Sankyo demonstrates our ability to support a wide spectrum of clinical and regulatory strategies," said CEO Dan Snyder in a statement.