TOKYO, March 14, 2022 /PRNewswire/ — The Ministry of Well being, Labour and Welfare (MHLW) has granted regulatory approval of Guardant360® CDx, a liquid biopsy take a look at for tumor mutation profiling, also referred to as complete genomic profiling (CGP), in sufferers with superior strong cancers. The Guardant360 CDx take a look at was additionally granted approval as a companion diagnostic to establish sufferers with microsatellite instability-high (MSI-Excessive) strong tumors who could profit from Keytruda® (pembrolizumab) and sufferers with MSI-Excessive superior colorectal most cancers (CRC) who could profit from Opdivo® (nivolumab). This regulatory approval has taken on an added significance as CRC is probably the most generally recognized most cancers in Japan1. Guardant360 CDx is obtainable by Guardant Well being Japan, a precision oncology firm based mostly in Tokyo which is an entirely owned subsidiary of Guardant Well being Asia, Center East & Africa (AMEA).
Moreover, in December 2021, MHLW granted regulatory approval of the Guardant360 CDx liquid biopsy take a look at as a companion diagnostic for figuring out sufferers with metastatic non-small cell lung most cancers (NSCLC) who could profit from remedy with LUMAKRAS™ (sotorasib), a KRAS G12C inhibitor developed and manufactured by Amgen.
“We’re delighted to obtain regulatory approval in Japan for the Guardant360 CDx take a look at. We strongly imagine that our liquid biopsy take a look at will assist to reinforce the standard of most cancers administration in Japan by providing tumor mutation profiling and companion diagnostics for therapies in sufferers whose tumors have KRAS G12C or MSI-Excessive standing. One of many key advantages of our liquid biopsy take a look at is that it allows physicians to match sufferers to acceptable remedy shortly with out the issues and delays of a tissue biopsy,” mentioned Simranjit Singh, Chief Government Officer of Guardant Well being AMEA and Consultant Director of Guardant Well being Japan.
“Guardant Well being Japan is devoted to bringing progressive and complete liquid biopsy checks akin to Guardant360 CDx to Japan in order that sufferers with superior stage most cancers can profit from genomic profiling info. This regulatory approval has been made doable due to the collaborations we now have with main most cancers consultants in Japan. We’re strongly dedicated to serving Japanese sufferers and physicians, and that is the primary of many merchandise within the Guardant portfolio which we plan to roll out within the close to future,” mentioned Gen Asano, Normal Supervisor of Guardant Well being Japan.
With only a easy blood draw from the affected person, the Guardant360 CDx take a look at helps information remedy choices for sufferers with superior stage most cancers. Having secured this regulatory approval, Guardant Well being Japan goals to drive scientific adoption of liquid biopsy testing in Japan and allow extra sufferers to obtain probably life-changing precision medicines.
About Guardant Well being Japan
Guardant Well being Japan is an entirely owned subsidiary of Guardant Well being AMEA, Inc., a three way partnership between SoftBank and Guardant Well being, Inc., a number one precision oncology firm targeted on serving to conquer most cancers globally via use of its proprietary blood checks, huge knowledge units and superior analytics. The Guardant Well being oncology platform is designed to leverage its capabilities in know-how, scientific improvement, regulatory and reimbursement to drive business adoption, enhance affected person scientific outcomes and decrease healthcare prices. Go to us on-line at https://guardanthealthjapan.com.
About Guardant360® CDx
Guardant360® CDx is Guardant Well being’s complete liquid biopsy take a look at which helps information remedy choices for sufferers with superior stage most cancers. It’s a main subsequent technology sequencing take a look at within the U.S. that analyzes circulating tumor DNA (ctDNA). ctDNA is produced when tumors shed small items of their genetic materials into the bloodstream. Traces of this ctDNA might be detected within the blood utilizing digital sequencing know-how. Guardant360 CDx was the primary liquid biopsy to obtain approval from the U.S. Meals and Drug Administration (FDA) in August 2020 for complete tumor mutation profiling throughout all strong cancers.
Reference
1. GLOBOCAN 2020 statistics obtainable at https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf accessed on 17 February 2022
SOURCE Guardant Well being
