Thermo Fisher Scientific announced today it has signed an agreement with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to co-develop a companion diagnostic (CDx) in oncology. The CDx will 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, which will be used to identify variant-positive patients for enrollment into clinical trials focused on non-small cell lung cancer (NSCLC). Additional indications in oncology may follow as part of the agreement.
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.
NGS is an established method of identifying gene variants at the center of several clinical trials or which are targeted by on-market and emerging therapies for cancer. Since its approval by the U.S. Food and Drug Administration in 2017, Oncomine Dx Target Test has been the focus of multiple drug development and clinical trial support agreements between Thermo Fisher and international pharmaceutical companies.
"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. "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."
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