Thermo Fisher Scientific announced it has signed an agreement with Janssen Biotech, Inc., to co-develop a companion diagnostic (CDx) initially focused on non-small cell lung cancer (NSCLC) that will also support clinical trial enrollment globally.
Under the agreement, Thermo Fisher Scientific will collaborate with Janssen Research & Development, scientists to validate multiple biomarkers for use with Thermo Fisher’s Oncomine Dx Target Test. In addition to the initial work in NSCLC, the companies have let the agreement open to include other indications in oncology in the future.
“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 programs requiring an NGS-based workflow that delivers actionable insights consistently,” said Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher Scientific, in a press release. “We are confident that this approach to patient stratification helps expedite drug development initiatives which ultimately are designed to promote better health outcomes through targeted therapies.”
Oncomine Dx Target Test received FDA approval in 2017 as a diagnostic that screened for which screens tumor samples for biomarkers associated with three FDA-approved drugs for non-small cell lung cancer, a breakthrough in cancer diagnostics, at the time.
Thermo Fisher has also been active in establishing co-development deals with pharma companies for Oncomine Dx’s use as a CDx. Notable partners include Eli Lily, Pfizer, Novartis, and Daiichi Sankyo, among others.
Oncomine Dx Target Test is a next-generation sequencing (NGS) assay that contains 46 cancer-related biomarkers and a workflow that features a fast turnaround time and the lowest sample requirements on the market for detection of both DNA and RNA variants.