Therapy Areas: Respiratory
Biocartis and AstraZeneca to develop CDx test for Tagrisso
22 June 2022 -

Molecular diagnostics company Biocartis Group NV (Euronext Brussels:BCART) announced on Wednesday an agreement with pharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) to develop a companion diagnostic (CDx) test for Tagrisso (osimertinib), AstraZeneca's third-generation EGFR-TKI (tyrosine kinase inhibitor) treatment.

The new test will use Biocartis' Idylla platform.

Under the agreement, Biocartis and AstraZeneca will co-lead the development and applicable pre-market notification or approval of the Idylla EGFR CDx Assay intended to aid in identifying patients with non-small cell lung cancer (NSCLC) who may respond to treatment with Tagrisso. In addition to FFPE tissue, Biocartis will seek to validate the use of less invasive cytology samples such as fine needle aspirates for use with the Idylla EGFR CDx Assay, to expand patient access to testing.

AstraZeneca is marketing Tagrisso, a lung cancer therapy approved for patients with resectable and locally advanced or metastatic NSCLC whose tumours have EGFR mutations. EGFR activating mutations are important biomarkers in NSCLC, occurring in 10-15% of all NSCLC patients in the US and the EU and in 30-40% of all NSCLC patients in Asia.



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