Roche Diagnostics Korea said Wednesday that Ventana anti-ALK CDx Assay, a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer patients treatable with its Alecensa, will receive insurance benefits from March 1.
The diagnostic test, an immunohistochemistry assay that detects ALK protein in NSCLC patients, first received regulatory approval in Korea in 2016 and gained additional approval as a companion diagnostic for Alecensa last August.
In contrast to conventional fluorescence in situ hybridization methods, the company’s test can detect the ALK mutation only with a smaller number of cancer cells as it only confirms if the cells are positive or negative with ALK mutation.
The company also used the method to check for ALK gene mutations in patients participating in the global phase 3 clinical trial of Alecensa.
The Ventana ALK test method and Alecensa are part of the company’s personalized healthcare -- a platform that links the diagnosis and treatment of patients -- the Roche group is introducing in Korea.
“With the reimbursement of Ventana ALK test method, we are very pleased to be able to diagnose the disease at a reasonable price and to start the treatment promptly,” Roche Diagnostics Korea CEO Richard Yiu said. “The company will do its best to provide various customized medical solutions for domestic patients and medical staff through continuous cooperation with Roche Korea.”
Roche Korea CEO Nic Horridge also said, “The company is pleased that both Alecensa, which proved a median progression-free survival of about three-years in ALK-positive non-small cell lung cancer and improved the central nervous system as a first line treatment, and Ventana ALK test method has both received insurance benefits.”
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