Thermo Fisher’s Oncomine Dx Target Test is the first US FDA approved targeted NGS in vitro diagnostic test for non-small cell lung cancer
Global healthcare technology company Thermo Fisher Scientific has agreed to expand its partnership with Daiichi Sankyo to co-develop a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC).
The co-developed CDx is aimed at identifying NSCLC in patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Enhertu.
The diagnostic will utilise Thermo Fisher’s next-generation sequencing (NGS)-based Oncomine Dx target test.
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.”
Oncomine Dx Target Test is the first US FDA approved NGS diagnostic test for NSCLC
Under the terms of the agreement, Thermo Fisher will hold rights to commercialise the test around the world and will seek approval from regulatory agencies.
The companies have initiated 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.
Thermo Fisher 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.
Enhertu is a HER2 directed antibody drug conjugate (ADC) currently under global phase 2 development for HER2 mutated or HER2 overexpressing NSCLC.
The company said that Enhertu showed superior response rate in patients with HER2 positive metastatic breast cancer, with preliminary results showing similar response in patients with metastatic NSCLC with HER2 mutation.
HER2 mutations are usually associated with breast cancers, but are considered a rare event in NSCLC.