US-based Thermo Fisher Scientific has partnered with Janssen Biotech to develop a companion diagnostic (CDx) in oncology.
Janssen Biotech is one of the Janssen Pharmaceutical companies of Johnson & Johnson (J&J).
Both companies will work together to validate multiple biomarkers to identify variant-positive patients for enrolment into clinical trials focused on non-small cell lung cancer (NSCLC).
The companies also expect additional indications in oncology for the CDx.
It will support Thermo Fisher’s Oncomine Dx Target Test, a next-generation sequencing (NGS) assay comprising 46 cancer-related biomarkers.
The test was approved by the US Food and Drug Administration (FDA) in 2007.
FDA approval enabled the test to be the focus of multiple drug development and clinical trial support agreements between Thermo Fisher and several international pharmaceutical companies.
The company had earlier signed agreements with Daiichi Sankyo and Takeda Pharmaceuticals to expand the use of Oncomine Dx Target Test.
The test provides a fast turnaround time and the lowest sample requirements on the market for detection of both DNA and RNA variants.
Commenting on the latest development, Thermo Fisher scientific life sciences solutions senior vice president and president Peter Silvester said: “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.
“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.”