AstraZeneca said Monday it is partnering with Swiss diagnostics maker Roche to create a plasma-based companion diagnostic for AZD9291, an investigational compound for the treatment of non-small-cell lung cancer.

The test will be used to identify epidermal growth factor receptor mutations in tumor tissue and plasma in patients with NSCLC and to improve the development of AZD9291 for patients who are resistant to EGFR tyrosine kinase inhibitors.

According to AstraZeneca, the test is based on circulating DNA in plasma samples and will provide a new method of identifying the mutation T790M. Patients treated with EGFR-TKIs whose disease has progressed normally require a biopsy to detect the mutation, the company said.

“Currently, late-stage lung cancer patients have to undergo surgery to collect tissue from a tumor so it can be sent for molecular testing,” said Paul Brown, head of Roche Molecular Diagnostics, adding that in some cases it’s not possible to collect sufficient tissue for testing. “This collaboration will enable molecular testing through plasma specimens and provide the information needed to inform treatment decisions without the complications of surgery,” he added.

In an ongoing Phase I study, AZD9291 has shown evidence of activity as a once daily monotherapy and been well-tolerated, AstraZeneca said.

NSCLC accounts for up to 85 percent of all lung cancers, the company said. Of those, about 70 percent have progressed to advanced or metastatic disease that is unresponsive to surgical resection. — Kellen Owings

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