The Medical Device Innovation Consortium (MDIC) has partnered with PerkinElmer’s Horizon Discovery to develop and manufacture somatic reference samples (SRSs) used for supporting validation of next-generation sequencing (NGS)-based cancer diagnostics.
The partnership is part of MDIC’s SRS Initiative, a collaboration among government agencies and industry partners. Having identified gaps in available somatic reference samples, the SRS Initiative seeks to improve the accuracy of NGS-based cancer diagnostics as well as create a global genomic data resource library with publicly available reference samples.
Using the CRISPR technology that the firm has refined over the previous decade, Horizon Discovery will develop and engineer ten SRSs specific to cancer types that have been prioritized by the SRS Initiative. This development and manufacturing process is expected to be completed by 2023.
The SRSs will then be comprehensively characterized, validated, and integrated, with the participation of the National Institute for Standards and Technology (NIST).
The SRSs are expected to be made commercially available through Horizon by early 2024; the characterization data will be available in publicly accessible databases.