More than 125 researchers, physicians, investors, and one Japanese government official filled the venue in Tokyo for what Craif calls the first conference in Japan devoted to the convergence of life sciences and AI.
Craif Inc., a bio-AI startup working on early cancer detection, used its first Bio-AI Summit to set out its regulatory timeline. Motoki Mikami, Craif's Head of Clinical Development and Regulatory Affairs, said final-stage clinical trials are underway in Japan with a view to obtaining regulatory approval in 2027, and that in the United States the company is pursuing a track aimed at Medicare reimbursement in 2028. Both dates are company targets that depend on regulatory and payer decisions Craif does not control.
The summit was held in Tokyo on September 30, 2025, in what the company describes as the first conference in Japan dedicated specifically to the convergence of life sciences and AI. Its theme was "The Tipping Point of Biotechnology and AI Convergence." The venue filled to capacity with more than 125 attendees: researchers, physicians, specialists, investors, and an official from Japan's Ministry of Economy, Trade and Industry (METI).
Bio-AI, as the speakers used the term, is the field that creates new value in health and medicine by generating and analyzing biological data suited to machine learning and building AI algorithms on it. Large amounts of capital are already going into it internationally and ecosystems are forming quickly. Craif's argument across four sessions was that Japan's comparative strength sits at the input layer, in the careful accumulation of reliable biological data, and that this is where an industry originating in Japan could compete globally.
Craif said it will develop the summit as a continuing initiative.
Why Craif Convened the Summit
In the opening session, CEO Ryuichi Onose described losing his grandparents to cancer and founding Craif in 2018 in response. He said it is a matter of pride that a Japanese company is competing globally, and spoke about what it means to take on healthcare problems worldwide.
"We hold proprietary bio-data that no one else in the world can access," Onose said. "When that data is analyzed by first-rate AI researchers with a deep understanding of biology, we can take on problems humanity has not been able to solve. I am convinced that this is where Japan can win."
The Clinical and Regulatory Update
The session on patient-centered medicine was the most concrete of the four.
Yasutaka Kato, a Project Assistant Professor in the Genomic Medicine Unit at the Keio University School of Medicine Cancer Center, presented research findings on pancreatic cancer detection using urinary microRNA and AI, and described the potential for a new approach built on early cancer detection.
Mikami set out the regulatory strategy and clinical development progress behind bringing the technology into wider use: final-stage clinical trials underway in Japan toward approval in 2027, and parallel work in the United States aimed at Medicare reimbursement in 2028.
Suega Mizunuma, PhD, Craif's COO, closed with an overview of the evidence generated on the platform to date, and highlighted a case in which lung cancer was found and treated at Stage 0.
Inside Craif's Bio-AI Platform
A second session opened Craif's lab and its analytics work to the room, covering both where biological data is generated and how it is turned into value.
Yuki Ichikawa, PhD, said putting bio-AI to practical use requires three things together: deep biological insight, an uncompromising commitment to data quality, and algorithm development specific to bio-AI.
Tomoko Tsuboi, who heads Craif's Chubu Testing Center, presented the controls the company uses to hold data quality, which she described as the foundation of bio-AI, and the operations behind what Craif says is a sustained record of zero findings in external audits.
Milos Havelka, PhD, Craif's Associate Director of Analytics and Bioinformatics, spoke about the difficulty of working with noisy biological data and the AI methods used to get past it.
Session video: https://youtu.be/0aCva45hsyQ
Where the Field Stands Globally
Kota Yamamoto, a Principal at Arthur D. Little Japan, gave the opening keynote on how bio-AI is defined and where investment is going. "Right now a bio-AI movement is spreading rapidly worldwide, in which companies generate their own bio-data and analyze it with AI to create new value, and investment is concentrating in the field," he said. "How a company takes up that current is starting to determine competitive advantage."
In the panel that followed, Kohei Yamamoto, Managing Partner at X&KSK, described the pattern he sees in the United States: "In deep tech fields including bio-AI, investors with real domain expertise gather in funds, and researchers, management talent and capital come together to create new industries."
Onose put Japan's position differently. "Japan's strength is in the process of patiently accumulating highly reliable bio-data, and that is the core of bio-AI, so there is every chance Japan can win there," he said. "From here, the key question is how we produce startups that succeed on a large scale globally."
What It Will Take for Japan to Compete
The closing session took up the practical question of how technology developed in Japan wins worldwide, from the perspectives of operators, management and policy.
Keisuke Honda, Co-Founder and General Partner at X&KSK, argued for defining the target first: "If you are going to achieve the goal of being number one in the world with technology developed in Japan, what matters is understanding what that goal actually is, as early as possible and in as much detail as possible."
Ei Fukumoto, Representative Director of KNOCKLEARN Inc., and Soshi Koike, Craif's Nagoya site head and head of recruiting, both pointed past technical expertise to organizational conditions, emphasizing a shared sense of purpose and a culture strong enough to hold a deep tech team together.
Masumi Takayama, a Deputy Director at METI, gave an overview of the government's existing support measures for deep tech startups expanding overseas, and spoke about the role the public sector should play and where policy may go next.
Summit Details
- Date: September 30, 2025
- Location: Nihonbashi TODA Hall, Tokyo
- Theme: The Tipping Point of Biotechnology and AI Convergence
- Attendance: more than 125, at venue capacity
- Organized by Craif Inc.
- More information: https://craif.com/summit/bioai-summit-2025
About Craif
Craif is a bio-AI startup, founded in 2018, working on the early detection of cancer. It combines AI with NANO IP (NANO Intelligence Platform), its proprietary analytical platform, which detects a diverse range of biomarkers including DNA and microRNAs with high accuracy from biofluids such as urine. On that basis the company is developing tests intended to make detection at the earliest possible stage, early treatment, and an early return to normal life possible. Craif's stated vision is a society in which people live out their natural lifespan, and it pursues that by bringing biotechnology and AI to bear widely across health and society.
Company Details
- Name: Craif Inc.
- Representative: Ryuichi Onose, Representative Director
- Founded: May 2018
- Business: research and development of next-generation tests for the early detection of disease and for personalized medicine, with a focus on cancer, and provision of the miSignal series of urine-based cancer risk tests
- Headquarters: THE PORTAL iidabashi B1F, 8-30 Shin-Ogawamachi, Shinjuku-ku, Tokyo
Web: https://craif.com/
