NEW YORK – Thermo Fisher Scientific and AstraZeneca said on Wednesday that they have signed an agreement to codevelop next-generation sequencing-based companion diagnostics to support AstraZeneca's portfolio of targeted therapies.
Financial and other details of the multiyear, global agreement were not disclosed.
Thermo Fisher noted that it currently offers the only NGS CDx solution — the Oncomine Dx Target Test — that's approved and reimbursed by government and commercial insurers in more than 15 countries, including the US, Japan, and South Korea, and multiple nations in Europe and the Middle East. The US Food and Drug Administration recently granted premarket approval to Oncomine Dx Target as a CDx to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for treatment with ivosidenib (Servier Pharmaceuticals' Tibsovo).
Thermo Fisher further said its research-use-only Ion Torrent Genexus System, which was launched in 2019, could also be used to expand patient access to precision therapies. The system is the first fully integrated NGS platform with an automated specimen-to-report workflow that delivers results in a single day and includes multiple solutions for solid tumor biomarkers and liquid biopsy testing.
In addition, the partners noted that more than 90 percent of AstraZeneca's clinical pipeline consists of targeted therapies, across several areas of research such as oncology, cardiovascular, renal, metabolic, and respiratory diseases.
"As the pipeline of targeted therapies expands, the availability of diagnostic tools that can interrogate multiple biomarkers simultaneously will ensure patients can be matched with the right therapies more rapidly — this is the promise of precision medicine," Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher, said in a statement. "Introduction of diagnostic tools early in the process of drug development can further facilitate the success of companion diagnostic development."