Vienna, Austria — 12. August 2026 — Lexogen, a specialist in RNA sequencing technologies and next-generation sequencing services, announces the availability of designated NGS service workflows operated in compliance with the principles of the World Health Organization’s Good Clinical Laboratory Practice guidance.
The offering is designed for clinical research and clinical-trial projects requiring enhanced controls for sample traceability, documentation, data integrity, technical review, and record retention. For projects formally designated as GCLP projects, Lexogen applies a documented quality framework covering relevant activities from project planning and sample receipt through library preparation, sequencing, approved bioinformatic processing, technical reporting, data delivery, and archiving.
A key feature of the service is the use of Lexogen’s proprietary RNA sequencing and library preparation products, which are manufactured under the company’s ISO 13485 quality management system. This system supports controlled production, product traceability, documented processes, and consistent quality. Where required by the study design, sample type, analytical objective, or customer specification, other commercially available products, reagents, and technologies may also be used following appropriate assessment, qualification, documentation, and traceability.
“Clinical research teams need sequencing partners that can deliver robust data through laboratory activities that are controlled, traceable, auditable, and reconstructable,” said Stephane Barges, CEO at Lexogen. “Our GCLP-compliant offering combines Lexogen’s RNA sequencing expertise and proprietary technologies with the quality standards needed for demanding clinical research.”
The precise project scope, including sample types, input requirements, library preparation technology, sequencing configuration, bioinformatic analysis, acceptance criteria, and reportable outputs, is agreed before project initiation and documented in the applicable study plan, statement of work, or quality agreement.
Lexogen has established a GCLP-compliant framework for designated clinical and preclinical service workflows. Compliance applies to projects conducted under defined GCLP controls and is based on Lexogen’s internal assessment, not external certification or accreditation.
For more information, visit www.lexogen.com/services or contact services@lexogen.com.
