Guardant Health Receives Regulatory Approval for Guardant360 CDx in Japan
PR94941
TOKYO, Mar. 14, 2022 /PRNewswire=KYODO JBN/--
Guardant360(R) CDx is a comprehensive genomic profiling test which utilizes
blood samples from patients with advanced solid cancers
The Ministry of Health, Labour and Welfare (MHLW) has granted regulatory
approval of Guardant360(R) CDx, a liquid biopsy test for tumor mutation
profiling, also known as comprehensive genomic profiling (CGP), in patients
with advanced solid cancers. The Guardant360 CDx test was also granted approval
as a companion diagnostic to identify patients with microsatellite
instability-high (MSI-High) solid tumors who may benefit from Keytruda(R)
(pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who
may benefit from Opdivo9(R) (nivolumab). This regulatory approval has taken on
an added significance as CRC is the most commonly diagnosed cancer in Japan1.
Guardant360 CDx is offered by Guardant Health Japan, a precision oncology
company based in Tokyo which is a wholly owned subsidiary of Guardant Health
Asia, Middle East & Africa (AMEA).
Additionally, in December 2021, MHLW granted 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(TM) (sotorasib), a KRAS G12C inhibitor developed
and manufactured by Amgen.
"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,
Chief Executive Officer of Guardant Health AMEA and Representative Director of
Guardant Health Japan.
"Guardant Health Japan is dedicated to bringing innovative and comprehensive
liquid biopsy tests such as Guardant360 CDx to Japan so that patients with
advanced stage cancer can benefit from genomic profiling information. This
regulatory approval has been made possible because of the collaborations we
have with leading cancer experts in Japan. We are strongly committed to serving
Japanese patients and physicians, and this is the first of many products in the
Guardant portfolio which we plan to roll out in the near future," said Gen
Asano, General Manager of Guardant Health Japan.
With just a simple blood draw from the patient, the Guardant360 CDx test helps
guide treatment decisions for patients with advanced stage cancer. Having
secured this regulatory approval, Guardant Health Japan aims to drive clinical
adoption of liquid biopsy testing in Japan and enable more patients to receive
potentially life-changing precision medicines.
About Guardant Health Japan
Guardant Health Japan is a wholly owned subsidiary of Guardant Health AMEA,
Inc., a joint venture between SoftBank and Guardant Health, Inc., a leading
precision oncology company focused on helping conquer cancer globally through
use of its proprietary blood tests, vast data sets and advanced analytics. The
Guardant Health oncology platform is designed to leverage its capabilities in
technology, clinical development, regulatory and reimbursement to drive
commercial adoption, improve patient clinical outcomes and lower healthcare
costs. Visit us online at https://guardanthealthjapan.com.
About Guardant360(R) CDx
Guardant360(R) CDx is Guardant Health's comprehensive liquid biopsy test which
helps guide treatment decisions for patients with advanced stage cancer. It is
a leading next generation sequencing test in the U.S. that analyzes circulating
tumor DNA (ctDNA). ctDNA is produced when tumors shed small pieces of their
genetic material into the bloodstream. Traces of this ctDNA can be detected in
the blood using digital sequencing technology. Guardant360 CDx was the first
liquid biopsy to receive approval from the U.S. Food and Drug Administration
(FDA) in August 2020 for comprehensive tumor mutation profiling across all
solid cancers.
Reference
1. GLOBOCAN 2020 statistics available at
https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf
accessed on 17 February 2022
SOURCE: Guardant Health
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