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Rapid Affordable Microbiota Analysis at the point of Need

Periodic Reporting for period 1 - RAMAN (Rapid Affordable Microbiota Analysis at the point of Need)

Berichtszeitraum: 2024-03-01 bis 2025-02-28

The RAMAN project addresses a pressing global challenge: the need for rapid, affordable, and comprehensive microbiota analysis in both medical and industrial sectors. Microbiomes — complex communities of microorganisms — play essential roles in human health, food production, and environmental balance. Yet, current analysis tools are often too slow, costly, or narrow in scope to meet urgent, real-world demands. This need is growing in response to major trends: aging populations, the rise of organic agriculture (with fewer chemical preservatives), and increasing biohazard risks from climate change. In medical contexts, such as childbirth, timely microbiota insights can be lifesaving. In food production, particularly in fermentation-based industries, fast microbial assessments help prevent spoilage and ensure quality. In the wellness sector, real-time microbiota analysis can influence consumer decisions.

RAMAN is developing the first TRL6-ready solution for Rapid and Affordable Microbiota Analysis at the Point of Need, advancing from a TRL4 prototype. The platform builds on three prior EU-funded H2020 projects and integrates proprietary micro-nano-bio innovations. It targets two critical use cases in medical diagnostics and in industrial applications. The first use case is dedicated to assessing the vaginal microbiota of pregnant women to reduce the risk of mother-to-newborn infections. In the field of industrial applications, RAMAN addresses to monitoring fermentation microbiota in beverages to enhance quality and prevent spoilage.

RAMAN addresses both regulated (healthcare) and non-regulated (industry) markets with a compact, automated, and eco-designed platform. In healthcare, it moves beyond standard Group B Streptococcus screening, with the potential to prevent up to 59% of childbirth-related infections in the EU and save lives in low- and middle-income countries (LMICs). It also opens avenues in gynecological diagnostics and premature birth prediction. In industry, RAMAN can significantly reduce 5–25% spoilage rates in organic wine and other fermented products, enabling producers to manage microbial risks in real time and improve compliance with organic standards.

RAMAN is fully aligned with the EIC Transition Challenge for micro-nano-bio devices and contributes to strengthening EU technological autonomy. Supported by 21 patents and a robust commercialization strategy, RAMAN is positioned to lead a new market segment, drive innovation, and generate an estimated €100M in revenue and over 100 jobs by 2032. By democratizing microbiota analysis, RAMAN transforms decision-making in healthcare and food systems alike.
Starting from TRL4, RAMAN has advanced key technologies to TRL5, ready for validation under TRL6 conditions. Five core technologies developed by BforCure have been significantly improved:

SmartDropper: A sample preparation tool enabling integrated sample/reagent mixing and precise droplet deposition. It has achieved validated reproducibility across workflows.

Molecular Petri Dish (MPD): Enables real-time, multiplexed detection of microorganisms at the single-cell level. In situ thermal lysis protocols, reagent optimization (including RT, polymerase, and probes with high signal-to-noise ratios), and gel matrix improvements have been validated using synthetic microbiota relevant to oenological and gynecological applications.

hcPCR Technology: A proprietary BforCure technology that increases the multiplexing level in a single reaction. Combined with endpoint melting curve analysis, MPD, and hcPCR algorithms have been integrated into the software of the Chronos Microbiota Device, enabling fast, high-resolution microbiota analysis.

Ortholigo™: BforCure’s proprietary software for in silico PCR design, updated to support the first microbiota test covering 96 bacterial species for synthetic microbiota applications.

Together, these achievements demonstrate a clear pathway from lab-scale innovation to commercial viability and TRL6 readiness.
RAMAN represents a significant leap in microbiota analysis, making real-time, multiplexed testing feasible at the point of need. Unlike traditional methods (e.g. sequencing or standard PCR), RAMAN is characterized by faster time-to-result (minutes to hours vs. days), lower cost per test, and greater accessibility, even in decentralized or resource-limited settings.

The technology supports single-cell resolution and high multiplexing, enabling detection of both beneficial and pathogenic species in a single workflow. This goes beyond the state of the art, where current methods are either too specific (e.g. pathogen-only tests) or too generalized (e.g. omics-based sequencing, which lacks speed and cost-efficiency).

RAMAN’s impact spans multiple domains. In healthcare, where there is a need of more accurate diagnostics for pregnancy-related infections and potential applications in STI detection, vaginal dysbiosis, and premature birth. Agri-food domain demands a precision fermentation management for organic producers, reducing economic losses and enhancing product quality. In the global health, the potential application of RAMAN achievements is in LMICs where high neonatal mortality is linked to untested microbial infections.

To ensure uptake and impact, the project addresses key enabling factors: market readiness (commercialization strategy and use-case validation are underway), IP and competitiveness (strong patent portfolio and first-mover advantage), funding and scale-up (business plan ready for investor engagement), standardization and regulation (ongoing work toward CE marking and regulatory alignment for medical diagnostics).

Future success depends on continued support for clinical trials, expanded testing libraries, and adaptation to additional use cases and markets.
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