Hospital teams can trial the company’s BSI/AMR test and preview the LiDia-SEQ system ahead of commercial launch.
DNAe has unveiled an early access program for its LiDia-SEQ next-generation sequencing diagnostic platform, inviting hospitals and clinical institutions to trial the company’s bloodstream infection and antimicrobial resistance test before commercial availability.
The program offers clinical partners exclusive pre-launch access to results generated by DNAe’s BSI/AMR test, which targets bloodstream infections and antimicrobial resistance, along with opportunities to participate in pilot placements of the automated NGS-based diagnostic system.
DNAe is accepting expressions of interest from hospitals, clinics and research institutions through its website, with particular focus on teams working in sepsis, infectious diseases, critical care and cancer applications.
“Our early access program launch is a pivotal moment in the evolution of the LiDia‑SEQ platform and the delivery of DNAe’s commercial roadmap,” says Samuel Reed, CEO of DNAe, in a release. “By offering pioneering hospitals and clinical partners experience of the results that can be generated by our flagship tests—ahead of commercial availability—what we are offering is an unprecedented opportunity to preview the future of NGS diagnostics.”
Two-Phase Program Structure
The program will roll out in two phases beginning in April 2026. Phase one will provide participating sites access to the BSI/AMR assay bench version, allowing teams to send whole blood samples and culture isolates to DNAe for research testing. Additional tests targeting other infectious diseases and oncology applications will follow.
Phase two involves on-site pilot placement of prototype LiDia-SEQ systems in select hospitals, enabling clinical teams to run DNAe’s BSI/AMR test within their facilities.
The early access program aims to generate published data demonstrating the performance and potential health system benefits of DNAe’s tests and proprietary NGS technology platform. The system is designed to fully automate the sample-to-result process within a single device, delivering results within hours.
BSI/AMR Test Capabilities
DNAe’s BSI/AMR test uses whole blood samples to detect bacterial and fungal pathogens along with key antimicrobial resistance markers for bacterial pathogens at clinically relevant concentrations of 3 CFU/mL or less. The test offers a testing menu of approximately 7,200 bacteria with 30 associated AMRs and 750 fungi.
The platform’s rapid NGS-based approach offers low limit of detection and faster time-to-result compared to current lab-based testing, delivering near-patient NGS testing capabilities for medical teams across hospitals, STAT labs and clinics.
Potential research areas include evaluations comparing the BSI/AMR test against current standard of care blood culture and other available clinical tests, plus modeling potential impact on clinical outcomes and health economic benefits.
DNAe recently presented data on its testing applications in oncology monitoring, bloodstream infection detection and antimicrobial resistance at the Association for Molecular Pathology Annual Meeting and Expo 2025 in Boston.
The London and Carlsbad, Calif-based company has received breakthrough device designation from the FDA for its platform and initial assay. DNAe has received funding from the Biomedical Advanced Research and Development Authority to develop its diagnostic platform for antimicrobial-resistant infections.
