Thermo Fisher Scientific Partners with AstraZeneca to Develop Solid Tissue and Blood-Based Companion Diagnostic Test for Tagrisso

Through ongoing collaboration, new companion diagnostic (CDx) aims to deliver next-generation sequencing results in as little as 24 hours to help advance precision oncology 

CARLSBAD, Calif. (Jan. 24, 2023) – As part of a global, multiyear agreement, Thermo Fisher Scientific today announced it is working with AstraZeneca to develop a solid tissue and blood-based companion diagnostic (CDx) test for Tagrisso (osimertinib). The CDx will help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with Tagrisso by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations including exon 21 L858R mutations, exon 19 deletions or T790M mutations. 

The collaboration will leverage the Oncomine Dx Express Test* on the Genexus Dx System*, a fully-integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that economically delivers results in as little as 24 hours to bring test results to clinicians and patients faster. NGS-based CDx testing offers the ability to detect multiple biomarkers from a single test, helping to match patients with an appropriate targeted therapy more quickly. The need for faster diagnostic turnaround times was reinforced by research presented at ASCO 2022 that found patients with advanced stage NSCLC had better outcomes, including survival rates, when molecular testing results were available early enough to inform initial treatment decisions. 

“As part of our ongoing partnership with AstraZeneca, today’s announcement will help bring targeted oncology treatments to more patients in need of new care options,” said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions.” 

Tagrisso is currently approved in numerous countries and regions around the world for the following indications: the treatment of patients with locally advanced or metastatic EGFR T790M mutation positive NSCLC; the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; and, the adjuvant treatment after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. 

To learn more about the Oncomine Dx Express Test, please visit www.oncomine.com/express-test  

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

About Thermo Fisher Scientific   

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.