Craif

What Craif does

Craif (Craif Inc. / 株式会社Craif) is a Japanese bio-AI company founded in May 2018 by CEO Ryuichi Onose and Nagoya University professor Takao Yasui to commercialize urinary microRNA-based liquid biopsy for early cancer detection. The company's core technology is the proprietary NANO IP® (NANO Intelligence Platform®) — a stack that combines microfluidic nanowire-based capture of extracellular vesicles from biofluids, next-generation sequencing of microRNAs, and in-house machine-learning models trained on what Craif describes as one of the world's largest urine biomarker databases (30,000+ clinical specimens and 50,000+ urine samples). It is complemented by Oyster®, an internally developed digital clinical-lab workflow that automates specimen handling in the company's registered Chubu Inspection Center in Nagoya and, as of April 2026, the Craif U.S. Laboratory in San Diego.

Craif monetizes this platform through four complementary test products sold under the miSignal® umbrella — Scan (urinary microRNA + AI evaluation of risk for 10 cancer types from stage 1), Lite (lower-priced metabolite-based screening), Navi (saliva-based hereditary cancer-risk test), and Check (DNA damage monitoring). Revenue is generated through a hybrid channel mix: direct-to-consumer e-commerce at misignal.jp, retail through 5,000+ drugstore and pharmacy storefronts plus electronics and department-store counters, B2B corporate employee-benefit contracts, and — launched April 2026 — Japan's first municipal public-procurement deployments. The company is also advancing two regulated medical-device programs: a urinary microRNA pancreatic-cancer diagnostic-support SaMD (pivotal trial underway, targeting 2027 Japan approval and 2028 US Medicare reimbursement) and a rapid SMA newborn screening kit (~1.5 hour turnaround), both leveraging the same underlying nucleic-acid detection platform.

The company operates from Tokyo (HQ), Nagoya (R&D lab inside Nagoya University), and Yokohama in Japan, and from Irvine (research lab, Feb 2025) and San Diego (JLABS and owned Bio-AI lab, Oct 2025 / April 2026) in the United States. It has 51–100 employees, has raised approximately US$35M+ across multiple equity rounds since 2019 with a deep corporate and strategic investor base (Daiwa House, Aflac, MUFG, Tokio Marine, Kirin, Toyota Boshoku, Toyoda Gosei, ANRI, Global Brain, X&KSK/Keisuke Honda), and is led by a PhD-heavy executive team that includes a US-local CFO recruited from Medtronic, Acutus Medical, and IRRAS to drive US-led global growth.

Name

Craif

Legal name

Craif株式会社 (Craif Inc.)

Website

https://craif.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

51–100 employees

Short description

Craif is a Japan-based bio-AI company that develops and sells urine-based microRNA cancer-risk tests (the miSignal® series) and is advancing a pancreatic-cancer diagnostic-support SaMD, serving consumers, medical institutions, corporates, and municipalities in Japan and expanding into the United States.

Ownership category

akta.pro rank

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B and B2C

Offering type

Services

Cost components

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

Revenue model

1. miSignal series test kit sales (B2C): Sale of miSignal Scan, miSignal Lite, miSignal Navi, and miSignal Check discrete urine/saliva cancer-risk test kits through own e-commerce (misignal.jp), drugstore/electronics retail shelves, and physical miSignal Shop locations. Each kit is a single-purchase test consumed with one submission.
2. Corporate employee-benefit contracts (B2B): Companies purchase miSignal Scan/Navi in volume as an employee (and sometimes spouse) wellness benefit (e.g., Aida Design, Denseisha, Iwatachizaki Construction, Yamato Transport). B2B bulk unit sales of test kits.
3. Local-government public-funding contracts: Public-procurement model where municipalities (e.g., Misato Town, Shimane) subsidize miSignal screening for residents via specific health-check programs; first national municipal deployment launched April 2026.
4. Future pancreatic-cancer SaMD (medical-device program) sales: Regulatory pathway product (in pivotal trial) that, upon 2027 Japan approval and 2028 US Medicare reimbursement target, will be sold/licensed to hospitals as a diagnostic-support software medical device.
5. Clinical research and joint-research services: Contracted joint-research studies with 50+ university hospitals and cancer research centers (Hokkaido University Hospital, Kyushu University, Nagoya University, Fujita Medical University, National Cancer Center East, etc.) covering technology validation and disease-area expansion (intractable disease detection).

Pricing tiers

Go-to-market motion1 record

Distribution channels7 records

Marketing channels4 records

Core offering

Craif develops and sells the miSignal® series of urine- and saliva-based cancer risk tests, built on its proprietary NANO IP® microfluidic exosome/nanowire capture platform combined with next-generation sequencing and AI/machine-learning algorithms. The flagship miSignal Scan evaluates risk for up to 10 cancer types from stage 1 using a small urine sample, supported by an in-house urine biomarker database of 30,000+ clinical specimens. The product line is sold directly to consumers via e-commerce and drugstores and to medical institutions, corporate wellness programs, and municipal public-health initiatives in Japan.

Product overview

Craif offers a platform-plus-modules architecture centered on its proprietary NANO IP® (NANO Intelligence Platform®) bio-AI technology stack, which combines microfluidic exosome capture, next-generation sequencing (NGS), and machine-learning algorithms to extract microRNA signals from small biofluid samples. On top of this platform, Craif delivers the consumer-facing miSignal® (My Signal) series — a portfolio of four complementary cancer-related tests: the flagship My Signal Scan (urinary microRNA + AI evaluation of 10 cancer types from stage 1), My Signal Light (affordable metabolite-based cancer risk screening), My Signal Navi (saliva-based genetic susceptibility test for 10 cancers), and My Signal Check (DNA damage monitoring). The company is also developing regulated medical-device products — a pancreatic cancer diagnostic aid (multi-center pivotal trial since 2024, targeting Japanese approval in 2027) and an SMA newborn screening kit — that share the same underlying nucleic-acid detection platform. Operations are powered by the internally developed Oyster® digital clinical lab system, which automates the Craif Central Inspection Center in Nagoya and the new Craif U.S. Laboratory in San Diego.

Differentiator

Problem solved

Functional benefit

Brands

• My Signal Scan (マイシグナル・スキャン): Flagship urinary microRNA + AI cancer risk test that evaluates risk for up to 10 cancer types from stage 1.
• My Signal Lite (マイシグナル・ライト)
• My Signal Navi (マイシグナル・ナビ)
• My Signal Check (マイシグナル・チェック)
• miSignal (マイシグナル®)
• NANO IP® (NANO Intelligence Platform®)

Products and services

• My Signal Scan (miSignal Scan / マイシグナル・スキャン) The flagship miSignal® test. Analyzes microRNA extracted from a small urine sample using Craif's proprietary bio-AI technology to evaluate risk for 10 cancer types (esophageal, gastric, pancreatic, lung, colorectal, ovarian, breast, kidney, bladder, prostate) from stage 1, with follow-up guidance to appropriate specialists.
• My Signal Lite (miSignal Lite / マイシグナル・ライト) A lower-priced urine test that detects metabolites leaking from cancer to enable early-stage cancer risk detection from stage 1, designed as an accessible price-point entry into the miSignal series.
• My Signal Navi (miSignal Navi / マイシグナル・ナビ) A once-in-a-lifetime saliva-based genetic test that analyzes lifetime hereditary cancer risk across 10 cancer types, complementing miSignal Scan with predisposition information.
• My Signal Check (miSignal Check / マイシグナル・チェック)

Named customers9 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature7 records

Partnerships

13 partnerships are on record, tiered major retail distribution partner (224 stores), first electronics-retail channel partner (24 stores), hospital channel partner offering misignal as a check-up option, flagship us incubator partner, flagship municipal partner (japan's first public-funded misignal deployment), major healthcare-distribution partner for the fukuoka pancreatic-cancer initiative, co-initiator of the fukuoka pancreatic-cancer initiative, major regional drugstore channel (500+ stores combined), founding academic partner — craif originated from nagoya university research; ongoing joint pancreatic-cancer screening research., key clinical research partners, joint-research partner for pancreatic-cancer early detection, joint-research partner (cancer-center network) and joint-research partner in fukuoka network.

• Kusuri no Lady / Lady Pharmacy (株式会社レデイ薬局)major retail distribution partner (224 stores)Channel Partner/ Reseller/ Distributor · 1 June 2026Distributes miSignal Scan and miSignal Lite across 224 stores in Shikoku/Chugoku region; full miSignal series sold via online store Kusuri no Lady Heart Shop.
• Bic Camera (ビックカメラ)first electronics-retail channel partner (24 stores)Channel Partner/ Reseller/ Distributor · 1 June 2026First electronics retailer to sell miSignal, across 24 Bic Camera stores nationwide (June 2026).
• Iseikai International Hospital (医誠会国際総合病院) — Human Dock SOPHIAhospital channel partner offering misignal as a check-up optionChannel Partner/ Reseller/ Distributor · 1 June 2026Adopted miSignal Scan as an optional test within the SOPHIA comprehensive health-check program.
• Johnson & Johnson — JLABS San Diegoflagship us incubator partnerStrategic or Co-development Partner · 1 April 2026Craif accepted into J&J's JLABS San Diego global life-science incubator (Oct 2025) and opened its own BioAI lab in San Diego (April 2026); supports US R&D and commercialization efforts.
• Misato Town, Shimane Prefecture (島根県美郷町)flagship municipal partner (japan's first public-funded misignal deployment)Strategic or Co-development Partner · 1 April 2026Co-launched the first national municipal public-funding deployment of miSignal for residents aged 40–74 in April 2026, with follow-up specialist medical coordination by local clinics.
• Sogo Medical (総合メディカル株式会社)major healthcare-distribution partner for the fukuoka pancreatic-cancer initiativeStrategic or Co-development Partner · 1 November 2025Co-initiator of the "Pancreatic Cancer Awareness Project in Fukuoka" (launched Nov 26, 2025) with Fukuoka Sanno Hospital, multiple pharmacy chains, and economic groups.
• Fukuoka Sanno Hospital (福岡山王病院)co-initiator of the fukuoka pancreatic-cancer initiativeStrategic or Co-development Partner · 1 November 2025Co-launch partner for the "Pancreatic Cancer Awareness Project in Fukuoka" and clinical-deployment partner for miSignal.
• Sogo-go Pharmacy, Drug Store Mori, Shindo Pharmacy, Drug Eleven (Fukuoka drugstore chains)major regional drugstore channel (500+ stores combined)Channel Partner/ Reseller/ DistributorDistribute miSignal in 500+ stores across Fukuoka and co-participate in the "Pancreatic Cancer Awareness Project in Fukuoka."
• Nagoya University (名古屋大学)founding academic partner — craif originated from nagoya university research; ongoing joint pancreatic-cancer screening research.Strategic or Co-development PartnerCo-founder Takao Yasui is a Nagoya University professor; ongoing joint pancreatic-cancer screening research and Craif's Nagoya lab sits inside the Nagoya University NIC building.
• Hokkaido University Hospital (北海道大学病院) and Iwanai Kyokai Hospital (岩内協会病院)key clinical research partnersStrategic or Co-development PartnerCo-conducted the Iwanai Town prospective study that resulted in detection and successful treatment of stage-0 lung cancer.
• Fujita Medical University (藤田医科大学)joint-research partner for pancreatic-cancer early detectionStrategic or Co-development PartnerCo-research partner with Nagoya University on the Tokai-region miSignal pancreatic-cancer screening study.
• National Cancer Center East Hospital (国立がん研究センター東病院)joint-research partner (cancer-center network)Strategic or Co-development PartnerListed as a joint-research partner in Craif's R&D team network.
• Kyushu University (国立大学法人九州大学)joint-research partner in fukuoka networkStrategic or Co-development PartnerJoint-research partner cited in Craif's "data about Craif" page along with National Cancer Center East Hospital and Hokkaido University.

Scale indicators10 records

Recent moves10 records

Expansion highlights4 records

Direct peers

• GRAIL: US-based multi-cancer early detection company (subsidiary of Illumina) commercializing Galleri, a blood-based MCED test that detects a cancer signal across 50+ cancer types. Directly comparable to Craif in target use case (early-stage multi-cancer screening) and clinical channel, but uses blood-based cfDNA methylation rather than urine microRNA.
• Guardant Health: US leader in liquid biopsy with Guardant360 (oncology) and Shield (blood-based CRC screening), plus an MCED pipeline. Comparable technology category (cell-free nucleic acids + AI), target customer (oncologists, hospitals), and pursuit of screening-market reimbursement.
• Natera: US-based cell-free DNA testing company with Signatera (MRD), Empower (hereditary cancer), and Vantage (hereditary) tests. Comparable in non-invasive cancer testing for both screening and monitoring use cases, with similar hospital-channel distribution and clinical evidence development.

Broad incumbents

• Exact Sciences: US diagnostics leader behind Cologuard (stool DNA CRC screening) that acquired Thrive Earlier Detection for MCED. Comparable as a multi-cancer screening platform with established US commercial scale, regulatory pathways, and payer coverage — much larger and further along than Craif.
• Sysmex: Japan-headquartered global leader in in-vitro diagnostics and hematology, expanding into liquid biopsy and cancer diagnostics. Comparable in offering clinical-grade cancer diagnostic tests to Japanese medical institutions and global channels, though as a much larger established player.

Emerging players

• Freenome: US-based multiomics (cfDNA + proteins) early-cancer detection company with multi-cancer and colorectal screening programs. Comparable technology stack (liquid biopsy + ML) and use case (early-stage cancer screening), but pursuing blood-based rather than urine-based biomarkers.
• Thrive Earlier Detection: Acquired by Exact Sciences in 2021, Thrive developed CancerSEEK, a blood-based MCED test. Comparable in multi-cancer early detection mission and academic-clinical validation approach; Craif's miSignal Scan addresses a similar use case via urine rather than blood.
• Universal Diagnostics: Spain-based blood-based multi-cancer screening company developing a colorectal screening test and broader MCED pipeline. Comparable early-stage cancer detection via liquid biopsy with an NGS + ML approach, though earlier stage and not yet commercial at scale.
• Datar Cancer Genetics: India-based cancer diagnostics company offering blood-based multi-cancer detection (Trucheck) and pursuing a similar early-detection commercial model with hospital channel partnerships. Comparable in MCED positioning and clinical validation approach but operating at smaller global scale.

Regional players

• H.U. Group Holdings: Japan-based clinical reference laboratory and diagnostics holding company (SRL, BML) operating centralized lab infrastructure for hospital and consumer testing across Japan. Comparable in Japanese clinical lab operations and serving similar medical-institution customers, though broader than cancer alone.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/Craif.Inc
• LinkedInlinkedin.com/company/craif-inc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors34 records

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M&A

Investments

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Frequently asked questions about Craif