Paris biotech One Biosciences outlines how single-cell transcriptomics can transform precision oncology by capturing the cellular complexity that traditional bulk sequencing misses. Founded by Institut Curie pioneer Dr. Céline Vallot, the company has secured over €20 million to bring OneMap™ diagnostic platform through clinical validation across Europe and the US.

Addressing the diagnostic blind spot in tumor complexity

Current cancer diagnostics face a fundamental limitation: bulk sequencing technologies average out cellular differences within tumors, missing the heterogeneity that drives treatment resistance and clinical failures. One Biosciences positions itself as the only company tackling this gap with clinical-grade single-cell transcriptomics specifically engineered for formalin-fixed, paraffin-embedded (FFPE) samples—the standard tissue preservation method used in clinical practice.

“We are the only company with this technology and strategy,” the CEO Hedi Brahim emphasizes, highlighting their unique positioning in addressing tumor heterogeneity through single-cell analysis integrated with proprietary AI signatures.

The company’s OneMap platform promises to deliver what traditional NGS cannot: a fine-grained, actionable profile of each tumor’s cellular landscape to guide both treatment decisions and clinical trial design. This approach targets a critical pain point for pharmaceutical and biotech companies struggling with clinical trial failures due to inadequate patient stratification.

From academic breakthrough to clinical translation strategy

One Biosciences emerged in 2020 from the convergence of cutting-edge science and seasoned industry expertise. Dr. Céline Vallot, a pioneer in single-cell biology applied to cancer at Institut Curie, recognized the translational potential of her academic breakthroughs. Co-founders Magali Richard and David Schilansky brought complementary pharma and venture experience to transform the science into clinical impact.

The company’s approach centers on supporting pharmaceutical and biotech companies to “improve outcomes of clinical trials by better selection of target, indications and patients in clinical trials.” This B2B focus on enhancing drug development efficiency represents a strategic departure from direct-to-clinic diagnostic models.

Lean team structure prioritizes bioinformatics capabilities

With 14 team members, One Biosciences maintains a deliberately focused organizational structure weighted toward computational expertise. The majority of the team consists of bioinformaticians and data specialists—a composition reflecting the platform’s reliance on AI-driven analysis of complex single-cell datasets.

This lean structure enables rapid iteration on algorithm development while maintaining cost efficiency during the clinical validation phase. The team operates from Biolabs Hôtel-Dieu Paris, leveraging the collaborative biotech ecosystem while maintaining partnerships with leading French institutions including Institut Curie, Gustave Roussy, and AP-HP.

Central lab model drives manufacturing and regulatory strategy

One Biosciences has adopted a central laboratory business model, receiving tissue samples and delivering analytical reports to physicians and pharmaceutical partners. This approach sidesteps the complexity of distributed diagnostic deployment while maintaining quality control over the specialized single-cell processing protocols.

The manufacturing strategy centers on establishing regulated laboratory capabilities rather than developing instrumentation for widespread distribution. The company is preparing to open a CLIA-certified laboratory in the United States to complement their European operations, enabling broader clinical study participation and eventual commercial expansion.

This centralized approach allows One Biosciences to maintain tight control over sample processing, data quality, and analytical consistency—critical factors for establishing clinical validity in the precision oncology space. The model also provides scalability advantages as the platform gains regulatory approval and market adoption.

Clinical validation pathway targets real-world feasibility

One Biosciences is conducting real-world studies across France and the US designed to demonstrate three critical success metrics: feasibility of single-cell analysis in routine clinical workflows, acceptable turnaround times for clinical decision-making, and measurable clinical value compared to existing diagnostic approaches.

The company’s near-term clinical development priorities include proving the feasibility of single-cell analysis for prospective samples and conducting large-scale trials to demonstrate added value over bulk sequencing in selected indications. These studies will provide the evidence base for regulatory submissions and commercial partnerships.

Regulatory discussions are already underway to define the pathway for OneMap as a regulated diagnostic product, with the company anticipating both FDA and European regulatory engagement as clinical data matures.

Interdisciplinary execution as competitive advantage

The founding team’s advice to fellow biotechs emphasizes the critical importance of interdisciplinary integration from company inception. “Build a deeply interdisciplinary team early—science, product, and clinical pathways must evolve together,” they advise, reflecting lessons learned in translating complex academic research into commercial applications.

The company also stresses the importance of end-user engagement throughout product development. “Stay close to end-users: clinicians and biopharma teams will shape your product as much as the data does,” highlighting their collaborative approach to platform refinement based on real-world clinical needs.

As One Biosciences concluded, “Be resilient—breakthrough science takes time to translate.” This perspective acknowledges the extended timelines required to validate novel diagnostic approaches while maintaining focus on the long-term clinical impact potential of single-cell precision oncology.