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AstraZeneca and Thermo Fisher Scientific Have Teamed up to Develop a New CDx Test

Friday, February 10, 2023

AstraZeneca and Thermo Fisher Scientific have partnered up to create a solid tissue and blood-based companion diagnostic (CDx) test for the medication Tagrisso (osimertinib).

The companies' global, multiyear agreement, which was signed in September 2021, includes this collaboration.

The Oncomine Dx Express Test*, a novel CDx test, is intended to identify patients with NSCLC who may benefit from Tagrisso treatment.

The epidermal growth factor receptor (EGFR) exon 21 L858R mutation, exon 19 deletions, and the T790M mutation are among the EGFR changes that the test will look for in malignancies.

The collaboration will use the Genexus Dx System, an entirely integrated next-generation sequencing (NGS) technology, to execute the novel test.

The technology contains an automated specimen-to-report procedure that delivers data in 24 hours to clinicians and patients more quickly.

NGS-based CDx testing can detect multiple biomarkers in a single test. This facilitates the more rapid matching of patients with appropriate targeted therapy.

In many countries and regions worldwide, Tagrisso is currently accepted as a first-line therapy for patients with locally progressed or metastatic EGFR T790M mutation-positive NSCLC, as well as for those whose tumours carry the L858R substitution mutation.

Additionally, it is licenced as an adjuvant therapy for NSCLC patients whose post-tumor resection tumours exhibit EGFR exon 19 deletions or exon 21 (L858R) replacement mutations.

The Oncomine Dx Express Test and the Genexus Dx instrument are currently available as CE-IVD.

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