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Natera Personalized Liquid Biopsy Cancer Test Receives CE Mark

NEW YORK – Natera said on Wednesday that it has received the CE mark for its Signatera personalized circulating tumor DNA test.

The test is optimized for molecular residual disease (MRD) assessment and for monitoring treatment in cancer patients.

With the CE mark in hand, Natera can now make the test available to clinics and hospital systems throughout Europe.

"Signatera represents a significant leap forward in how we treat cancer patients in the adjuvant, neoadjuvant, and metastatic settings," said Andrés Cervantes, professor of medicine and head of the department of medical oncology at the University Hospital of the University of Valencia, Spain, in a statement. "We look forward to incorporating this technology into MRD-guided clinical trials and into clinical practice across a variety of solid tumor types."

"To our knowledge, this is the first bespoke assay to ever receive the CE mark, a testament to the strength of our scientific and regulatory teams, and a milestone in our journey to making Signatera a standard of care for cancer management worldwide," said Solomon Moshkevich, Natera's general manager of oncology, in a statement.

The Signatera test, which received breakthrough device designation from the US Food and Drug Administration last year, is personalized for each patient. It is designed by sequencing the exome of a patient's tumor and selecting the top 16 clonal mutations, which the test assesses in circulating tumor DNA using targeted sequencing.