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Biocartis, AstraZeneca Expand Lung Cancer Biomarker Study With Master Collaboration Agreement

NEW YORK – Belgium-based Biocartis has signed a master collaboration agreement with AstraZeneca, expanding an existing partnership that aims to demonstrate how Biocartis' Idylla platform can reduce the complexity and long turnaround time of biomarker testing for lung cancer patients.

As part of the collaboration, the companies will widen their tissue-based lung cancer study to additional countries in and outside of Europe. The group believes the new agreement will allow co-development and commercialization projects, including companion diagnostic development that cover any type of indication or biomarker.

Under the new agreement, the firms will also launch a project to evaluate if liquid biopsy testing using the Idylla ctEGFR mutation assay could offer further benefits to tissue-based EGFR molecular testing.

AstraZeneca currently markets Tagrisso (osimertinib), which acts as a lung cancer therapy approved for metastatic non-small cell lung cancer (NSCLC) patients whose tumors have EGFR mutations. 

"Current EGFR molecular diagnostic testing is difficult, especially in NSCLC, where tumors are often very small, leading often up to several weeks of waiting time before results are available," Biocartis CEO Herman Verrelst said in a statement. "Liquid biopsy EGFR testing with the Idylla ctEGFR Mutation Assay, operating directly from 2 ml of blood plasma, could overcome these challenges and delivers molecular EGFR mutation information faster and easier."

Financial and other details of the agreement and studies were not disclosed.

At the JP Morgan conference earlier this month, Verrelst noted that Biocartis expects US market clearance later this year for its Idylla MSI test for colorectal cancer via a 510(k) submission to the US Food and Drug Administration.