Thermo Fisher, Johnson & Johnson to co-develop NSCLC companion diagnostic

Thermo Fisher Scientific announced Thursday that it entered into an agreement with Johnson & Johnson's Janssen Biotech unit to co-develop a companion diagnostic for non-small-cell lung cancer (NSCLC). The agreement, whose financial terms were not disclosed, calls for the companies to validate multiple biomarkers for use with Thermo Fisher's next-generation sequencing (NGS)-based Oncomine Dx target test to identify patients for enrolment into global NSCLC studies.

Peter Silvester, president of life sciences solutions at Thermo Fisher, remarked that "the ability of the Oncomine Dx target test to rapidly detect variants of interest from very small quantities of DNA or RNA samples makes this technology ideally suited to support development programmes requiring a NGS-based workflow that delivers actionable insights consistently." As part of the agreement, additional indications in oncology may follow.

The Oncomine Dx target test received FDA approval in 2017 as the first companion diagnostic test to simultaneously screen for multiple NSCLC therapies, and was later awarded the CE mark as an in vitro diagnostic for the detection of 46 cancer-driver gene variants. The test has also been the focus of other drug development and clinical trial support agreements, including with Blueprint Medicines and Eli Lilly.