Keita Saito, Chief Technology OfficerAt the heart of its solution is Dozyme, a groundbreaking artificial enzyme powered by DNA origami. Folding DNA strands into precise nanostructures creates scaffolds for attaching various functional components, such as proteins and tags. This enables Dozyme to precisely target and identify specific nucleic acid sequences, including those for COVID-19, E. coli and HPV.
“Our technology is poised to transform the diagnostic landscape, making testing faster, simpler and more accessible for everyone,” says Keita Saito, chief technology officer.
With a versatile platform for rapid test development that targets emerging pathogens, it is well-suited for healthcare, food safety and environmental monitoring.
Overcoming Limitations of Traditional PCR Testing
Traditional polymerase chain reaction (PCR) tests, while accurate, rely on expensive machinery and complex procedures. They require temperatures exceeding 90°C for sample amplification and specialized fluorescent detection equipment. Cranebio bypasses these obstacles by amplifying the gene to make it easy to detect without any machinery. Delivering results accuracy equivalent to or greater than existing techniques using a visual detection method compatible with smartphone cameras, Cranebio makes advanced nucleic acid testing device-less and accessible to everyone.
Its Dozyme system, comprising DNA origami, gene fasteners and enzyme fragments, operates on a targeted activation principle that only starts when it encounters specific nucleic acid sequences from pathogens. Initially, the enzyme is split and inactive, positioned on opposite sides of the DNA origami structure. Upon binding to nucleic acid sequences in a sample, the DNA scaffold undergoes a structural change that brings the enzymatic components together, activating a cascade. This triggers a reaction that produces a visible signal, translating genetic information directly into light and eliminating the need for complex detection equipment. The luminescence produced by Dozyme enables detection via a smartphone or luminometer.
An excellent example is its detection of coronavirus RNA. In experiments where the artificial enzyme was used with the target sequence of SARS-CoV-2 amplified by RT-RPA and transcribed by T7 polymerase, samples without SARS-CoV-2 RNA showed weak luminescence. In contrast, those containing as few as 10² RNA copies displayed strong luminescence that could be detected on a smartphone, demonstrating Dozyme’s remarkable accessibility and sensitivity.
The Dozyme Advantage
Cranebio makes nucleic acid testing available in self-testing kits, available online for use at home with minimal equipment.
When working with the Cranebio’s home kit, users can add their sample to the reaction card and press designated spots-similar to popping a tablet from blister packaging-to mix the sample with the reagents and initiate the reaction. The process takes just an hour and results are displayed in the app, making it user-friendly for anyone, even without specialized training.
Priced at just $20 to $30 per test, Cranebio’s kits offer significant savings compared to traditional PCR tests, which typically cost around $100 in Japan. This affordability is achieved by eliminating the need for specialized equipment and operator involvement, making it a practical option for widespread use. At the same time, the test’s simplicity leaves the door open for innovative design possibilities for future advancements, such as multiplexing.
Our technology is poised to transform the diagnostic landscape, making testing faster, simpler and more accessible for everyone
Beyond these competencies, Cranebio addresses the challenge of false positives caused by contamination; a critical concern for at-home testing. Its reagents work through simple mixing while its strategies to prevent dispersion of amplification product ensure consistent accuracy and reliability.
It also plans to develop a device that can simultaneously handle 8–16 reactions , to accommodate professionals looking for cost-effective bulk testing. While this is a departure from its device-less approach, it’s a practical solution for a specific need, further demonstrating Cranebio’s commitment to making genetic testing affordable and accessible.
A Whole World of Applications Awaits
Cranebio is advancing healthcare innovation with novel applications such as a wearable testing kit for women. This kit integrates a lateral flow immunoassay into a panty liner, providing a convenient tool for health monitoring. Its recent ovulation prediction kit, launched in Japan, further highlights the company’s commitment to groundbreaking solutions. Saito also wants to focus on oncology, particularly early cancer detection and disease management, with HPV as an initial target. In oral health, a recent partnership has paved the way for developing a periodontitis management kit, showcasing Cranebio’s ability to tackle complex health challenges with versatile solutions. It is now exploring opportunities for growth in the U.S.
The technology’s applications extend far beyond medical diagnostics. It offers transformative testing solutions for food and water safety inspections, delivering immediate insights that enhance safety protocols and prevent potential outbreaks. This contrasts with traditional methods, which rely on time-consuming cultivation techniques that can take days to produce results.
In addition, Dozyme-based testing has significant potential in livestock diagnostics, including applications for cows, pigs and chickens. For instance, avian influenza outbreaks often force poultry farmers to cull entire flocks as a precautionary measure. Cranebio’s highly sensitive testing approach could help identify non-infected chickens for isolation, reducing losses and improving disease management. This capability demonstrates how the technology can address critical challenges across diverse industries.
At the Forefront of Next-Generation Diagnostics
The global PCR testing market, valued at around $9 billion, presents a significant opportunity. Offering a cost-effective and user-friendly solution that overcomes the limitations of traditional testing techniques, Cranebio stands at the forefront of next-generation diagnostics.
Its scalable and adaptable technology is designed to meet both current and future healthcare needs, ensuring timely and accurate treatments that enhance patient care and outcomes. With a mission to revolutionize diagnostics, the company’s versatile platform enables rapid test development across diverse applications. Supported by strong distribution partners, Cranebio is well-positioned to drive growth in healthcare, food safety and environmental monitoring, improving quality of life on a global scale.
By making advanced diagnostics accessible to all, Cranebio is gaining a competitive edge while redefining the future of diagnostic testing.
