Cancer remains one of the leading causes of mortality globally, with alarming statistics highlighting its impact. In 2022, nearly 20 million new cancer cases were reported, resulting in approximately 9.7 million deaths. Projections indicate that by 2040, the number of new cases could surge to nearly 30 million, underscoring the urgent need for effective detection methods.
A groundbreaking startup, established in 2018 as a spin-off from a prestigious university in Japan, has developed an innovative software solution that leverages microRNA (miRNA) for early cancer detection. Recently, this company successfully raised $22 million in Series C funding, which will be instrumental in expanding its reach into the U.S. market and enhancing its research and development efforts.
The co-founder and CEO of the startup shared insights with TechCrunch, revealing that the latest funding round valued the company at just under $100 million. This significant investment was led by an existing investor, marking a total of $57 million raised to date, alongside contributions from various U.S.-based investors.
The inception of this startup was deeply personal for its founders, particularly the CEO, who witnessed the devastating effects of cancer on his family. This experience fueled a passion to create solutions that could help others facing similar challenges. Together with a university associate professor, they co-founded the company shortly after discovering a novel method for early cancer detection utilizing urinary biomarkers.
Traditional diagnostic methods often pose challenges, as they can be invasive and deter individuals from seeking regular screenings. The CEO emphasized that limited access to healthcare facilities further complicates the situation for many people. In response, the startup aims to fill these gaps by offering a non-invasive urine-based test that facilitates early cancer detection, even at the initial stages of the disease.
“Our test can be performed conveniently at home and utilizes advanced microRNA analysis, making early detection more accessible and effective,” the CEO explained. “Our target audience includes health-conscious individuals who are concerned about cancer but face barriers to conventional screening methods due to time, cost, and accessibility.”
In a competitive landscape, several startups are also working on early cancer detection solutions. However, this company distinguishes itself by focusing on microRNA as a biomarker, in contrast to the more common cell-free DNA (cfDNA) approach used by many competitors.
“miRNA has gained significant attention due to its critical role in cancer biology, especially in the early stages,” the CEO noted. “Unlike cfDNA, miRNA is actively secreted by early cancer cells, making it particularly effective for early detection.”
Another innovative aspect of their product is the use of urine as a sample. The CEO highlighted that urine is a non-invasive option that offers numerous scientific advantages, including clearer biomarker signals and reduced measurement errors compared to blood samples.
The startup’s flagship product, miSignal, is designed to assess the risk of seven different types of cancer through urinary miRNA analysis. This product is already generating revenue in Japan, with distribution channels that include clinics, pharmacies, and direct-to-consumer sales, providing diverse revenue streams.
“We have established partnerships with over 1,000 medical institutions and approximately 600 pharmacies in Japan, serving around 20,000 users. Our dedicated team consists of 73 employees,” the CEO shared.
The revenue model includes both individual tests and subscription packages for ongoing testing, with many users opting for the latter. The company reported $5 million in revenue for 2024 and aims to reach $15 million by the end of the year.
Looking ahead, the startup plans to expand the miSignal product line to include ten different cancer types this year. Additionally, they are preparing to adapt their technology for the early detection of non-cancerous diseases, such as neurodegenerative conditions like dementia.
With a research and development lab located in California, the startup is also planning to establish a new office in San Diego to support its business operations. The recent funding will facilitate their entry into the U.S. market with their microRNA-based early cancer detection test, with trials expected to commence around 2029, followed by an application for FDA approval.
Currently, the company is collaborating with 30 medical institutions across 15 U.S. states to collect pancreatic cancer samples, marking a significant step in their mission to revolutionize cancer detection.
This article has been updated to clarify the startup’s plans for U.S. trials.