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