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Thermo Fisher Scientific, Daiichi Sankyo Partner to Develop Non-Small Cell Lung Cancer CDx

NEW YORK – Thermo Fisher Scientific and Daiichi Sankyo said today that they have partnered to develop a companion diagnostic for patients with non-small cell lung cancer (NSCLC).

The assay will use Thermo Fisher's Oncomine Dx Target sequencing test. It will be designed to identify NSCLC patients with mutations in HER2 who may be eligible for treatment with Enhertu (DS-8201), a HER2-directed antibody-drug-conjugate under development at Daiichi that is currently being tested in Phase II for HER2-mutated or HER2-overexpressing NSCLC.

Daiichi and its partner AstraZeneca recently reported from the DESTINY-Lung01 trial that Enhertu shrank tumors in 26 out of 42 patients with HER2-mutated, metastatic NSCLC.

The new collaboration follows a 2018 agreement between the two companies to use the Oncomine Dx Target test in clinical trials and drug development programs at Daiichi.

The Oncomine test was approved by the US Food and Drug Administration as a companion diagnostic for NSCLC in 2017. It is designed to evaluate multiple biomarkers associated with cancer and identify patients eligible for multiple FDA-approved targeted therapies.