A unit of Johnson & Johnson is working with one of the country’s largest makers of diagnostics and lab-testing equipment to develop a companion diagnostic for cancer clinical trials.
Carlsbad, California-based Thermo Fisher Scientific said Thursday that it had partnered with New Brunswick, New Jersey-based J&J’s Janssen Research & Development to develop a companion diagnostic that would support global enrollment in clinical trials, particularly in non-small cell lung cancer. The agreement also allows for other indications in oncology, Thermo Fisher said. The diagnostic will rely on Thermo Fisher’s Oncomine Dx Target Test, a next-generation sequencing testing system, and be used to validate multiple biomarkers.
“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,” Thermo Fisher president for life sciences solutions Peter Silvester said in a statement. “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.”
The deal follows a similar partnership between Thermo Fisher and Indianapolis-based Eli Lilly. In September 2019, it signed an agreement with Lilly’s oncology unit to develop a companion diagnostic for use with selpercatinib, also known as LOXO-292. In that case, the test is being developed to look for RET fusions, which are the molecular target of selpercatinib, including in patients with NSCLC, as well as thyroid cancer and others.
The J&J announcement did not name specific drugs or targets, though lazertinib – an EGFR inhibitor – is an NSCLC drug in the company’s development pipeline for which it plans to file for approval between this year and 2023 and that is in multiple clinical trials. ClinicalTrials.gov also lists studies of NSCLC products targeting FGFR and KRAS mutations.
Companion diagnostics that use NGS are an important component of targeted oncology therapy, given their ability to find druggable mutations, particularly those that are rare and whose inhibition carries a relatively high probability of clinical response.
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