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A specialty clinical laboratory had developed and validated a PCR-based laboratory developed test (LDT) filling a genuine unmet diagnostic need — with no FDA-cleared alternative on the market. The test had accumulated strong clinical evidence through years of CLIA-validated use. The laboratory wanted a credible, cost-efficient regulatory pathway to transition from LDT to cleared IVD — without the infrastructure or regulatory expertise of a large diagnostics manufacturer.

Boudicca® DX evaluated the available FDA pathways and identified the De Novo request as the appropriate route for a novel, low-to-moderate risk test with no predicate — positioning the laboratory to establish the first FDA-cleared device of its kind and create the regulatory precedent for the category. BDX authored the Breakthrough Device Designation (BDD) request, making the dual case that the test addressed an unmet clinical need and that existing clinical evidence demonstrated meaningful patient benefit. FDA granted BDD. Boudicca® DX is now leading preparation of the De Novo submission, including special documentation requirements enabled by the designation.

An AAV gene therapy company developing a treatment for a rare disease required a total antibody (TAb) assay to screen and monitor patients for pre-existing immunity to the AAV vector — a critical patient selection and safety tool for their first-in-human (FIH) clinical program. Speed was essential: delays to a FIH trial in a rare disease with no approved treatment carry real patient impact. The company needed regulatory submissions prepared for both the UK MHRA (Clinical Trial Authorisation) and US FDA (IDE), while simultaneously managing European trial sites where a costly and timeline-adding IVD performance evaluation study was not a viable option. Each jurisdiction had distinct documentation requirements, and the submissions needed to be executed without generating requests for information that would delay first patient in.

Boudicca® DX prepared the UK MHRA clinical trial submission package for the TAb assay in accordance with MHRA requirements — including the checklist and tabular summary format specified in MHRA guidance for investigational medicinal product authorisation. BDX simultaneously prepared the US FDA IDE submission using the eStar template via the CDRH Collaboration Portal. Critically, the same core analytical performance data package was used across all three jurisdictions — maximising efficiency and ensuring consistency across submissions. Both the MHRA and FDA submissions were received with zero requests for information. For European trial sites, Boudicca® DX structured an in-house testing strategy under the IVDR Article 5(5) health institution exemption for the AAV TAb assay — anchored to the same analytical performance data and eliminating the need for a separate, costly performance evaluation study.

A biopharmaceutical company developing a targeted therapy for solid tumors needed a globally coordinated CDx strategy spanning China, Japan, the US, and Europe simultaneously. In China, the therapy was approved and hospital testing was needed to support patient identification. Japan required its own CDx approval through PMDA. The US CDx required a clinical bridging study to support an NGS-based companion diagnostic sPMA submission. And in Europe, the company faced the question of how to align with EMA on biomarker testing without imposing a uniform global CDx requirement that would limit access in markets where local tumor profiling platforms were already established. Each jurisdiction carried distinct regulatory expectations, timelines, and negotiating dynamics.

Boudicca® DX worked with the biopharmaceutical company and CDx manufacturer to design a CDx clinical bridging study that served as the evidentiary foundation across all four jurisdictions — maximising the value of a single clinical dataset. In China, BDX supported a hospital testing approach for the approved therapy, enabling patient identification without a separate CDx registration pathway. In Japan, BDX navigated the PMDA CDx pathway to achieve CDx approval. In the US, BDX used the bridging study data to support an NGS CDx sPMA submission currently under FDA review, and negotiated a 2-year CDx postmarket commitment with FDA — deferring remaining development obligations. For Europe, the biopharmaceutical company is negotiating with EMA on an approach that leverages local tumor profiling testing — with Boudicca® DX providing the regulatory strategy and technical support to preserve patient access across EU member states where different NGS platforms are in clinical use.

A biopharmaceutical company running a rare disease clinical trial needed to activate French sites for patient eligibility testing using a PCR-based genotyping assay operated by their US CLIA/CAP-accredited testing laboratory. The French competent authority (ANSM) required a formal EU IVDR performance study application under Regulation (EU) 2017/746 — the only accepted pathway for this type of US-based investigational assay in France. The laboratory had robust CLIA-validated analytical data, but that data was documented in formats designed for US regulatory purposes, not the EU IVDR performance study framework specified in MDCG 2022-19. The lab had no prior EU IVDR experience. Generating entirely new performance data was neither practical nor scientifically necessary — the challenge was translation, not re-validation.

Boudicca® DX, engaged by the biopharmaceutical company, worked directly with the US CLIA/CAP laboratory to conduct a systematic extraction of its existing analytical validation documentation — identifying all data elements relevant to the MDCG 2022-19 performance study application requirements under EU IVDR. BDX mapped the existing US validation evidence to the EU analytical performance framework — including accuracy, precision, specificity, and interference data — and generated the complete suite of EU IVDR performance study application documents in the format and structure required by ANSM. The submission went through the French competent authority review successfully, enabling the biopharmaceutical company's clinical trial to proceed at French sites on schedule.