Japan’s Ministry of Health, Labour and Welfare has granted regulatory approval of the Guardant 360 CdX.

MDDI Staff

March 16, 2022

1 Min Read
Japan Is the Next Stop for Guardant’s Liquid Biopsy Test

Guardant Health is expanding its liquid biopsy offerings to Japan. The Redwood City, CA-based company said Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of the Guardant360 CDx.

This follows MHLW granting regulatory approval of the Guardant360 CDx liquid biopsy test as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with Lumakras (sotorasib).

Guardant360 CDx is offered by Guardant Health Japan, a precision oncology company based in Tokyo, which is a wholly-owned subsidiary of Guardant HealthAsia, Middle East & Africa (AMEA).

"We are delighted to receive regulatory approval in Japan for the Guardant360 CDx test. We strongly believe that our liquid biopsy test will help to enhance the quality of cancer management in Japan by offering tumor mutation profiling and companion diagnostics for therapies in patients whose tumors have KRAS G12C or MSI-High status. One of the key benefits of our liquid biopsy test is that it enables physicians to match patients to appropriate treatment quickly without the complications and delays of a tissue biopsy," said Simranjit Singh, CEO of Guardant Health AMEA and Representative Director of Guardant Health Japan.


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