Thermo Fisher, AstraZeneca team up on multiyear companion diagnostic project for drugmaker's precision medicine pipeline

Thermo Fisher Scientific announced it would work with AstraZeneca to co-develop genetic companion diagnostics for the British drugmaker’s expanding slate of targeted therapies.

The multiyear, global agreement will focus on sequencing-based tests designed to identify patients most likely to benefit from specific treatments for cancer and other diseases and point them toward the proper regimen based on their individual genetic results.

"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, Thermo Fisher’s president of clinical next-generation sequencing and oncology, said in a statement. Financial terms of the collaboration were not disclosed.

Currently, more than 90% of AstraZeneca’s clinical drug candidates are based on the targeted approach, spanning its work in cancer and cardiovascular disease as well as kidney, metabolic and respiratory conditions. Meanwhile, the company has launched four targeted medicines in the past seven years that are linked with 16 companion diagnostics.

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Going forward, the two companies also plan to introduce paired-up diagnostic tools early in the process of drug development and clinical trials, Hampton said, so tests are ready to launch alongside a therapy’s FDA approval.

By eventually distributing these tests to local healthcare providers on a global scale, the companion diagnostics will help uncover more patients eligible for targeted therapies, said AstraZeneca’s senior vice president of precision medicine and biosamples, Ruth March, Ph.D.

This year, the Big Pharma also stepped up efforts to drive awareness of biomarker screening as well as lobbying campaigns for state-level legislation to instruct insurers to cover genomic testing.

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In late August, Thermo Fisher garnered an FDA approval for a companion diagnostic for Servier Pharmaceuticals’ Tibsovo (ivosidenib) for patients with bile duct cancer carrying a specific genetic marker.

The drug received a green light last month, making it the first targeted therapy in the indication. In aggressive cases of cholangiocarcinoma, about 20% of tumors bear IDH1 mutations, providing a target for Servier’s inhibitor drug.

Thermo Fisher also recently received an FDA clearance for a blood test that aims to reduce the number of false positives when diagnosing cases of lupus. The new EliA SmD(P)-S autoimmune antibody test replaces a previous version and is more accurate at distinguishing cases of systemic lupus erythematosus from mixed connective tissue disease, or MCTD.