Thermo Fisher Scientific has expanded its partnership with Daiichi Sankyo to jointly develop a companion diagnostic (CDx) for its next-generation sequencing (NGS)-based Oncomine Dx Target Test.

The CDx is designed to identify non-small cell lung cancer (NSCLC) in patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Enhertu.

Enhertu is a HER2 directed antibody-drug conjugate (ADC), which is currently under global phase 2 development for HER2 mutated or HER2 overexpressing NSCLC.

HER2 mutations are usually associated with breast cancers but are considered a rare event in NSCLC. However, recent studies found that HER2 mutations played a key role in NSCLC.

Also, Enhertu showed superior response rate in patients with HER2 positive metastatic breast cancer, with preliminary results showing a similar response in patients with metastatic NSCLC with HER2 mutation.

Thermo Fisher and Daiichi Sankyo signed the first partnership agreement in 2018

The company said that its Oncomine Dx Target Test marks the first US Food and Drug Administration (FDA) approved targeted NGS in vitro diagnostic test for NSCLC.

The test has been designed to evaluate multiple biomarkers associated with cancer and identify patients who are eligible for multiple FDA-approved targeted therapies using a single sample with results available in days.

The companies have initiated a partnership in 2018, through an agreement to expand the clinical utility of the test in support of clinical trials and drug development programs at Daiichi Sankyo.

The current agreement expands the existing partnership, enabling Thermo Fisher to hold rights to commercialise the test around the world and seek approval from regulatory agencies.

Thermo Fisher Scientific clinical next-generation sequencing and oncology president Garret Hampton said: “Our latest partnership with Daiichi Sankyo is focused on helping to solve an unmet medical need for a growing number of patients with HER2-mutated non-small cell lung cancer.

“This agreement underscores our continued commitment to working with global pharmaceutical partners to efficiently identify more patients who may benefit from the latest targeted therapies in their drug pipelines.”