Blood test provides a simple way for healthcare professionals to test for KRAS/NRAS wild-type, BRAF V600E and ERBB2 copy number alteration in patients with unresectable advanced or recurrent colorectal cancer

October 13, 2023, Tokyo, Japan – Guardant Health Japan Corp. (Head office: Minato-ku, Tokyo; CEO AMEA: Simranjit Singh) today announced the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Guardant360^® CDx liquid biopsy test as a companion diagnostic to select targeted therapies for patients with unresectable advanced or recurrent colorectal cancer for KRAS/NRAS wild-type, BRAF V600E, and ERBB2 copy number alteration.

Guardant360 CDx is a liquid biopsy test approved by MHLW on March 10, 2022 to analyze circulating tumor DNA (ctDNA) from the blood samples of ptients with advanced solid tumors. Guardant360® CDx offers comprehensive genomic profiling that detects genetic mutations in the ctDNA that is shed by cancer into the bloodstream of patients with solid tumors. The assay concurrently examines 74 cancer-related genes, while  providing a companion diagnostic for multiple cancer drugs approved in Japan.

Guardant360 CDx is the first test in Japan^*1 that is a companion diagnostic for KRAS/NRAS wild-type, BRAF V600E, and microsatellite instability high, all of which are recommended by Japanese Society for Cancer of the Colon and Rectum (JSCCR) for analysis prior to first-line treatment of advanced colorectal cancer^*2,3,4. JSCCR also recommends evaluation of ERBB2 copy number alteration to guide treatment for patients with unresectable advanced or recurrent colorectal cancer.

“There is a growing need for treatment options that improve clinical outcomes of colorectal cancer,” said Simranjit Singh, CEO Guardant Health Asia, Middle East and Africa. “With this approval, we expect that colorectal cancer patients with KRAS/NRAS wild-type, BRAF V600E, and ERBB2 copy number alteration will have improved access to appropriate molecular targeted therapy,” Mr Singh concluded.

• *1 As of October 2023
• *2 “Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer” – evidence to be added to drug therapy for unresectable advanced or recurrent colorectal cancer in the JSCCR Guidelines 2022 for the Treatment of Colorectal Cancer (for doctors), (March 2022)
• *3 Nakamura et al Nature Med 2021 https://doi.org/10.1038/s41591-021-01553-w
• *4 Aoki et al JCO Precis Oncol 2023 https://doi.org/10.1200/PO.22.00688

Product information

Note: Underlined items have been added with this approval

About Guardant360 CDx
For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment.
Since being introduced, Guardant360 has become widely accepted for blood-based comprehensive genomic profiling with more than 400 peer-reviewed publications. It has been used by more than 12,000 oncologists, with more than 500,000 tests performed to date, and is broadly covered by Medicare and private payers, insuring over 300 million people.

About Guardant Health AMEA
Guardant Health AMEA is a wholly owned subsidiary of Guardant Health, Inc., a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360^®, Guardant360^® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY™ tests for patients with advanced-stage cancer, and Guardant Reveal™ for patients with early-stage cancer. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealthamea.com  and follow the company on LinkedIn, Twitter and Facebook.

Contact:
Guardant Health Japan Communications
press_japan@guardanthealth.com

See full press release in Japanese here: https://guardanthealthjapan.com/202310130_01/