Biocartis In Deal With AstraZeneca To Develop Companion Diagnostic Test For Tagrisso

Biocartis Group NV, a Belgium-based molecular diagnostics company, announced Wednesday that it has entered into an agreement with British drug major AstraZeneca Plc. (AZN,AZN.L) for the development and marketing of a companion diagnostic test for Tagrisso (osimertinib), a lung cancer therapy.

Tagrisso is AstraZeneca's third-generation EGFR-TKI (tyrosine kinase inhibitor) treatment approved for patients with resectable and locally advanced or metastatic NSCLC whose tumors have EGFR mutations.

Under the deal terms, Biocartis and AstraZeneca will co-lead the development and applicable pre-market notification or approval with the US FDA of a novel companion diagnostic or CDx test on Biocartis' molecular rapid and easy-to-use diagnostics Idylla platform, for use with Tagrisso.

The Idylla EGFR CDx Assay is intended to aid in identifying patients with non-small cell lung cancer or NSCLC who may respond to treatment with Tagrisso. The development of a companion diagnostic test on Idylla is expected to enable faster and broader patient access to Tagrisso treatment.

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.

The new project expands the companies' existing master collaboration agreement announced in January 2020, aimed at boosting access to faster molecular diagnostic biomarker results with the rapid and easy-to-use Idylla EGFR testing products.

Herman Verrelst, Chief Executive Officer of Biocartis, said, "Current EGFR molecular diagnostic testing remains a real challenge in the clinical practice. Obtaining high quality tissue samples is difficult and complex, especially in NSCLC where tumors are frequently very small, often leading up to several weeks of waiting time before results are available, as opposed to what we can offer with the Idylla technology."

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