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Thermo Fisher, Janssen Biotech to Develop CDx for Lung Cancer, Other Indications

NEW YORK – Thermo Fisher Scientific said on Thursday that it has teamed up with Janssen Biotech, a member of Johnson & Johnson's Janssen Pharmaceutical Companies, to develop a companion diagnostic test to support clinical trial enrollment of cancer patients.

Under the deal, scientists at Thermo Fisher and Janssen Research & Development will initially validate biomarkers for use with the Thermo Fisher Oncomine Dx Target Test to identify non-small cell lung cancer (NSCLC) patients for enrollment into clinical trials. The firms may add other cancer indications later on.

The Oncomine Dx Target Test is a next-gen sequencing assay that covers 46 cancer biomarkers. It was approved by the US Food and Drug Administration as a CDx for NSCLC in 2017 and requires only small amounts of DNA or RNA, according to the company.

Since then, Thermo Fisher has struck agreements with several pharmaceutical firms, including Eli Lilly, Daiichi Sankyo, and Takeda Pharmaceuticals, to use the test as a CDx in clinical trials and drug development programs.

"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," said Peter Silvester, senior VP and president of life sciences solutions at Thermo Fisher Scientific, in a statement.