AstraZeneca, Biocartis team up to develop companion diagnostic for lung cancer drug Tagrisso
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AstraZeneca (NASDAQ:AZN) and Belgium's Biocartis Group signed an agreement to develop and commercialize a novel companion diagnostic (CDx) test for use with the British drugmaker's lung cancer drug Tagrisso.
A companion diagnostic is a test that helps determine if a particular therapy's benefit to patients will outweigh any potential serious side effects or risks, and also helps identify patients who are more likely to benefit from a particular drug, according to the FDA.

The CDx test will be made using Biocartis' diagnostics platform Idylla.
Under the agreement, Biocartis and AstraZeneca will co-lead the development and applicable premarket notification or approval of the Idylla EGFR CDx assay aimed to aid in identifying patients who may respond to treatment with Tagrisso, which is used to treat patients with resectable and locally advanced or metastatic NSCLC whose tumors have EGFR mutations.
In addition to FFPE tissue, Biocartis will seek to validate the use of less invasive cytology samples such as fine needle aspirates to use with the new test to expand patient access to testing, Biocartis said in a June 22 press release.
The new project expands an existing collaboration between the two companies aimed at boosting access to faster molecular diagnostic biomarker results with the Idylla EGFR testing products.