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Biocartis, AstraZeneca Ink Companion Diagnostic Pact

NEW YORK – Belgian molecular diagnostics firm Biocartis said on Wednesday that it will develop a molecular test to identify patients with non-small cell lung cancer most likely to respond to AstraZeneca's Tagrisso (osimertinib) treatment.

According to Biocartis, the partners will work together to obtain US regulatory clearance of the companion diagnostic for Tagrisso, which is used to treat NSCLC patients who carry specific mutations. Tagrisso is AstraZeneca's third-generation EGFR tyrosine kinase inhibitor treatment.

Biocartis plans to validate the test, called Idylla EGFR CDx Assay, in formalin-fixed, paraffin-embedded tissue samples, as well as in cytology samples such as fine needle aspirates. The work builds upon an earlier agreement announced in January 2020.

Biocartis CEO Herman Verrelst said in a statement that the Idylla EGFR CDx Assay "may enable faster and broader patient access" to Tagrisso. He added that current EGFR molecular testing is a "real challenge" for clinicians and that obtaining high quality samples is "difficult and complex, especially in NSCLC where tumors are frequently very small," and that it can take several weeks for results to become available.

According to Verrelst, a companion diagnostic offered on Biocartis' automated, real-time PCR platform can change that dynamic.

Financial terms of the new agreement with AstraZeneca were not disclosed.