Guardant Health Japan

What Guardant Health Japan does

Guardant Health Japan Corp. (ガーダントヘルスジャパン株式会社) is the Japanese operating subsidiary of Guardant Health AMEA, a joint venture between U.S.-based precision oncology company Guardant Health, Inc. (NASDAQ: GH) and SoftBank Group. Founded in June 2018, the company commercializes liquid biopsy technology for cancer genomic profiling in the Japanese market, headquartered in Tokyo Port City Takeshiba with an R&D laboratory at Shonan Health Innovation Park (Shonan iPark). The company serves Japanese oncologists, designated cancer genome medical institutions (13 core hospitals, 32 hub hospitals, and 249 affiliated hospitals as of February 2026), and solid cancer patients across the country.

The company's flagship product is Guardant360® CDx がん遺伝子パネル, a next-generation sequencing-based liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from a simple blood draw to evaluate 74 cancer-related genes and four major mutation types. PMDA approved the test as a medical device program in March 2022, commercial launch and national health insurance reimbursement began in July 2023, and the test has subsequently been approved as a companion diagnostic for multiple targeted therapies including pembrolizumab, nivolumab, sotorasib, trastuzumab deruxtecan, amivantamab, encorafenib, cetuximab, and pertuzumab. The company also distributes Shield® 大腸がん ctDNA 検査, an NGS-based blood test for colorectal cancer screening (currently an unapproved LDT), in partnership with BML.

Guardant Health Japan generates revenue through two primary streams: (1) usage-based diagnostic testing services reimbursed under Japan's national health insurance system, with sample collection and processing handled by laboratory partners SRL (H.U. Group Holdings) for Guardant360 CDx and BML for Shield, and (2) companion diagnostic partnerships with pharmaceutical manufacturers tied to specific targeted therapy approvals. The company employs a direct enterprise field sales model via Regional Account Managers and Medical Science Liaisons, supported by HCP-targeted marketing channels including medical conference seminars, on-demand webinars, an email newsletter, and a dedicated HCP portal. Leadership comprises Representative Director Simranjit Singh (also CEO of Guardant Health AMEA) and President Representative Director Mika Takagi.

Name

Guardant Health Japan

Legal name

ガーダントヘルスジャパン株式会社 (Guardant Health Japan Corp.)

Website

https://guardanthealthjapan.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Guardant Health Japan Corp. commercializes liquid biopsy-based cancer genomic profiling tests (Guardant360 CDx and Shield colorectal screening) to Japanese oncologists and designated cancer genome hospitals, generating revenue through national health insurance reimbursement and laboratory partner channels.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Companion Diagnostics (CDx) Development & Commercialization (HLAAANAC), Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ)

Keywords

• Liquid biopsy diagnostics
• Cancer genomic profiling
• Companion diagnostics
• CtDNA testing
• Precision oncology

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Marketing or Sales, Operations, Others

Revenue model

1. Diagnostic Testing Services: Guardant360 CDx is reimbursed under Japan's national health insurance system. Testing is performed through contracted laboratory partners who collect samples and deliver results to designated cancer genome medical institutions. Revenue is generated through insurance claims for comprehensive cancer genomic profiling tests and companion diagnostics.
2. Companion Diagnostics Partnerships: Guardant360 CDx serves as a companion diagnostic for multiple approved cancer drugs in Japan, enabling pharmaceutical companies to identify patients eligible for targeted therapies. This creates partnerships with drug manufacturers for companion diagnostic indications.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Guardant Health Japan commercializes the Guardant360 CDx cancer gene panel, a liquid biopsy test that uses next-generation sequencing to analyze circulating tumor DNA (ctDNA) from a blood sample and report genomic alterations across 74 cancer-related genes for comprehensive genomic profiling of solid tumors. The company also offers Shield, a blood-based ctDNA screening test for colorectal cancer, and provides companion diagnostic testing services for multiple targeted cancer therapies through contracted laboratory partners SRL and BML to designated cancer genome medical institutions across Japan.

Product overview

Guardant Health Japan offers a portfolio of liquid biopsy (liquid biopsy) diagnostic products and services for cancer genomic profiling. The core product is Guardant360® CDx, a comprehensive cancer gene panel test using next-generation sequencing (NGS) technology to detect circulating tumor DNA (ctDNA) from blood samples. This is complemented by Shield®, a colorectal cancer ctDNA screening test. The products enable comprehensive genomic profiling (CGP) of solid tumors, supporting personalized cancer treatment decisions through companion diagnostics for multiple targeted therapies. Testing services are delivered through partnerships with clinical laboratory operators SRL and BML, with results provided to designated cancer genome medical institutions.

Differentiator

Problem solved

Functional benefit

Brands

• Guardant360® CDx: Liquid biopsy-based comprehensive cancer genomic profiling (CGP) test that analyzes circulating tumor DNA (ctDNA) from blood samples to detect genomic alterations in 74 genes for solid tumor patients.
• Shield® 大腸がん ctDNA 検査

Products and services

• Guardant360 CDx Cancer Gene Panel (Guardant360® CDx がん遺伝子パネル) A comprehensive liquid biopsy cancer gene panel using next-generation sequencing (NGS) to detect and analyze circulating tumor DNA (ctDNA) from whole blood samples. Evaluates 74 cancer-related genes and identifies multiple mutation types including KRAS G12C, MSI-High, ERBB2 copy number abnormalities, ESR1 mutations, EGFR exon 20 insertion mutations, BRAF V600E mutations, and KRAS/NRAS wild-type status. Approved in Japan as a medical device program for comprehensive genomic profiling in solid cancer patients, serving as a companion diagnostic for multiple targeted therapies including pembrolizumab, nivolumab, sotorasib, trastuzumab deruxtecan, amivantamab, encorafenib, cetuximab, and pertuzumab. Target customers are oncologists and designated cancer genome medical institutions in Japan.
• Shield Colorectal Cancer ctDNA Test (Shield® 大腸がん ctDNA 検査) A blood-based colorectal cancer screening test using next-generation sequencing technology to detect cancer-specific genomic changes (genetic abnormalities, methylation, and fragmentation patterns) with high sensitivity. Analyzes circulating tumor DNA (ctDNA) to detect colorectal cancer signals. Demonstrated efficacy in the ECLIPSE trial with over 10,000 subjects aged 45-84. Currently an unapproved LDT in Japan, available through partnership with BML.

Quantifiable outcome

• Patients receiving liquid biopsy-guided targeted therapy showed approximately 2x longer survival (18.6 months median OS vs 9.9 months for unmatched patients)
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Five partnerships are on record, tiered major and core.

• BML (ビー・エム・エル)majorChannel Partner/ Reseller/ Distributor · 26 September 2023Business partnership for providing Shield colorectal cancer ctDNA test services. BML, a clinical testing company founded in 1955, handles sample collection and testing for the blood-based colorectal cancer screening test using next-generation sequencing technology.
• SRL (株式会社エスアールエル)coreChannel Partner/ Reseller/ Distributor · 24 October 2022Business partnership for providing Guardant360 CDx testing services. SRL, Japan's largest clinical testing laboratory under H.U. Group Holdings with capacity for 400 million tests annually, handles sample collection and processing at CAP-certified facilities, delivering results to healthcare institutions within approximately 14 days.
• Guardant Health AMEA (Asia, Middle East & Africa)coreStrategic or Co-development Partner · 25 February 2020Guardant Health AMEA is a joint venture between Guardant Health, Inc. and SoftBank Group, established to expand Guardant Health's liquid biopsy technology across Asia, Middle East, and Africa. Guardant Health Japan is the Japanese subsidiary of Guardant Health AMEA, focusing on bringing liquid biopsy technology to the Japanese market.
• Shonan Health Innovation Park (Shonan iPark)majorStrategic or Co-development Partner · 25 February 2020Guardant Health Japan established its Shonan Laboratory at Shonan Health Innovation Park, an innovation campus created by Takeda Pharmaceutical when it opened its Shonan Research Institute to pharmaceutical startups. The park aims to accelerate open innovation in next-generation medicine through collaboration between pharmaceutical companies, venture startups, academia, and government.
• National Cancer Research Center East Hospital (GOZILA Study)coreStrategic or Co-development Partner · 1 January 2018GOZILA Study is a large-scale liquid biopsy genomic screening project conducted with approximately 7,000 gastrointestinal cancer patients across 31 facilities in Japan, led by the National Cancer Center East Hospital. The study demonstrated that liquid biopsy-guided treatment resulted in approximately 2x longer survival for advanced cancer patients and results were published in Nature Medicine.

Scale indicators4 records

Recent moves9 records

Expansion highlights5 records

Broad incumbents

• Sysmex Corporation: Japanese in-vitro diagnostics giant and major player in hematology, oncology, and clinical lab instrumentation. A broad incumbent in the Japanese diagnostics market with capability and channel relationships to enter or expand in liquid biopsy oncology testing.
• Guardant Health Inc. US-based parent (NASDAQ:GH) and developer of the Guardant360 CDx technology that Guardant Health Japan commercializes. Direct technology and IP source, operates the same products in the US and globally, and is the obvious benchmark for valuation and pipeline.

Direct peers

• Tempus Labs: US-based precision medicine company offering NGS-based oncology testing including liquid biopsy profiling. Competes head-to-head with Guardant Health in the CGP/CDx space and is expanding internationally, positioning itself as a future competitor in Japan.
• Exact Sciences: US-based cancer diagnostics company behind Cologuard, the leading non-invasive colorectal cancer screening test. Directly comparable to Guardant Health Japan's Shield blood-based colorectal screening test, both targeting the same screening population with non-invasive alternatives to colonoscopy and FIT.
• Foundation Medicine: Roche-owned molecular profiling company offering FoundationOne CDx, the leading tissue-based comprehensive genomic profiling test used in Japan's cancer genome medical institutions. The most direct competitor to Guardant360 CDx in the Japanese CGP market, with established pharma CDx partnerships and broader gene coverage in tissue.

Others

• Chugai Pharmaceutical: Roche's Japanese affiliate and a major oncology drug manufacturer that distributes Foundation Medicine's tests in Japan. Functions as both a potential CDx customer (competing with Guardant360 CDx partnerships) and a relevant channel for Japan's precision oncology ecosystem.

Emerging players

• Caris Life Sciences: Precision oncology company offering molecular profiling (Caris Assure, Caris Molecular Intelligence) for therapy selection, including liquid biopsy components. Direct competitor in the CGP and CDx market with a growing pharma partnership pipeline.
• Natera: US-based cell-free DNA testing company with Signatera (MRD) and other oncology tests. While primarily MRD-focused, Natera represents a comparable liquid biopsy oncology platform pursuing CDx-style partnerships with pharma companies.
• Personalis: US-based molecular diagnostics company offering tumor profiling for cancer therapy selection, including immuno-oncology and MRD applications. Emerging competitor in the precision oncology and CDx space where Guardant Health Japan competes.

Regional players

• H.U. Group Holdings: Japanese clinical laboratory group that owns SRL, Guardant Health Japan's largest lab partner for Guardant360 CDx. While primarily a lab services partner, H.U. Group's clinical testing scale and oncology testing ambitions make it a regional strategic peer.

Market position

Strengths5 records

Weaknesses2 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/guardant-health-japan

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Guardant Health Japan