A portable platform based on AI and rapid genetic tests to tackle infections and antibiotic resistance even outside the laboratory

GeneSys Bio is a next-generation diagnostic platform that operates at the intersection of molecular biology, artificial intelligence, and decentralized healthcare. The project was born with the specific goal of making the most advanced technologies available and accessible for the rapid, sensitive, and specific detection of major pathogens, overcoming the constraints of location, time, and infrastructure that still limit traditional molecular diagnostics.

At the core of GeneSys is a innovative sample-to-result genetic technology, conceived as an evolution of molecular analysis and capable of accompanying the entire process, from sample to result, at the service of the clinician and the patient.

The startup's development path includes participation in the April 2024 Maverx Innovation Bootcamp, an experience that allowed GeneSys Bio to interact with the network built by the Maverx Foundation, an organization committed to supporting health-tech startups through mentoring programs and matchmaking opportunities with companies in the Biomedical Valley of Mirandola, in a context that fosters dialogue between technological innovation, the biomedical industry, and concrete clinical applications.

The structural problem of the current diagnostic model

In the field of infection diagnostics, GeneSys Bio moves from a structural problem that has burdened healthcare systems for decades, as well as the combination of slow diagnostic processes and empiric antibiotic use, which has directly contributed to the spread of antimicrobial resistance, now recognized as a major global health emergency. Urinary tract infections are a case in point, with approximately 400 million episodes recorded each year globally and 240 associated deaths.

At the same time, antimicrobial resistance is responsible for approximately one million deaths each year and is closely linked to the difficulty of rapidly identifying the pathogen and its resistance profile. The current diagnostic gold standard relies on laboratory procedures that require three to five days; a time lag that often leads to untargeted therapies, with significant clinical and economic consequences. It is precisely in this critical space that the proposal developed by GeneSys Bio fits.

From criticality to solution: the model proposed by the startup

GeneSys Bio's answer to this structural limitation is a portable, AI-driven diagnostic platform designed to bring real-time genetic testing even outside the laboratoryUnlike traditional cultures, which require three to five days, dedicated infrastructure, and guarantee an accuracy of 80 to 90 percent, the GeneSys system allows for a diagnosis in 15 to 45 minutes, directly on site, without the need for a laboratory or sample pre-treatment, with a declared accuracy of 98 percent.

The device is based on a compact real-time isothermal PCR system, designed for professional and decentralized settings such as primary care, elderly care, veterinary diagnostics, and field use. A proprietary thermal block design, combined with a lens- and filter-free optical detection system, also makes the device more robust and low-maintenance, while the workflow is fully automated and supported by an AI-based operating system, capable of limiting false positives and negatives and providing clear results even to non-specialized personnel.

How the system works, between diagnostic kit and data analysis

Going into detail, the performance of the GeneSys platform derives from the combination of three key elements: diagnostic kits to owners, device design e artificial intelligence system that governs the entire process. The kits, based on LAMP technology, use lyophilized reagents and a buffer with a calibrated formulation to maximize efficiency, along with primers designed to ensure maximum specificity even under extreme conditions. Under optimal conditions, testing time can be less than 15 minutes.

From a hardware standpoint, the platform revolves around the aforementioned Real Time LAMP PCR device, developed for truly portable use. Battery-powered, it integrates innovations in the configuration of optical and heating components. The system also features a code or QR code locking mechanism, allowing for complete traceability of each test.

On the software front, internal artificial intelligence is designed to increase data sensitivity and reduce false positives and false negatives. Completing the ecosystem, a dedicated app and dashboard allow for monitoring patient health status and analyzing anonymized data, supporting both clinical decisions and public health assessments.

One platform, multiple kits, to guarantee the patient a single health

In day-to-day operation, the GeneSys platform is designed to simplify access to molecular diagnostics as much as possibleThe test is started by scanning the QR code on the kit using the GeneSys app, or by manually entering the alphanumeric code on the device's display. Once the kit has been verified, the system automatically enables the instrument, loads the correct analytical protocol, and records the test details. The operator is then prompted to enter the patient's data, or a unique code if pre-registered, before starting the analysis after inserting the sample.

The entire process requires no pretreatment, and upon completion, the results are displayed on the screen and can be transferred to the app via Bluetooth. In a single analysis, the platform can identify up to five pathogens and their corresponding antibiotic resistance profiles.

Looking to the future, GeneSys aims for a One Health model, with a single platform and multiple kits applicable to humans, animals, and the environment. Since 2023, the project has already raised €400 in funding and networking and launched four research projects.

The skills and experiences that shaped the project

Leading the development of GeneSys Bio is a team with a strongly interdisciplinary profile, which combines scientific, industrial, and business expertise gained over decades of activity. Overall, the group brings together over a hundred years of experience and a portfolio of more than ten patents and thirty scientific publications.

At the helm is Andrea Faviere, CEO, with a background in business development, marketing, and sales. The clinical and entrepreneurial side is represented by Enrico Di Oto, doctor and PhD with experience in hospital diagnostics and biotech, while the scientific direction is entrusted to Simone Di Giacomo, CSO, with over fifteen years of research in molecular biology. The role of CTO is held by Luciano Ranieri, an entrepreneur with more than fifty years of experience in medical device development. The team is also supported by international figures such as John Tompkins, Michael Henry, Dean Zikria e Vittoria Pavoncello.

Looking ahead, GeneSys aims to validate the product in Denmark, Germany, and the United Kingdom, launch a wellness kit, and advance the certification process for urinary tract infections. This growth plan is supported by a €800 round of funding, of which €500 has already been subscribed.

Andrea Faviere of GeneSys Bio's pitch at "Biomedical Valley" in Mirandola (Modena)

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