The Medical Device Innovation Consortium (MDIC) and PerkinElmer‘s Horizon Discovery have collaborated to boost the precision of next-generation sequencing (NGS)-based cancer diagnostics.
The collaboration will focus on the development and manufacturing of somatic reference samples (SRSs) to simplify the validation of NGS-based cancer tests.
Under the partnership, Horizon will leverage clustered regularly interspaced short palindromic repeats (CRISPR)-based technology to engineer and produce ten SRSs, with each of a different variant or having a change in the DNA sequence of a gene that is clinically related to a certain kind of cancer.
MDIC will gather and disseminate the best practices for improving the sustainability and efficiency of reference sample production, validation, and dataset generation, after the completion of the project.
The SRSs will undergo an extensive characterisation and validation process.
For this process, MIDC and Horizon Discovery will work along with the National Institute for Standards and Technology (NIST).
The manufacturing process of SRS is anticipated to complete by next year, and the fully characterised SRS will become available commercially via Horizon by early 2024.
MDIC president and CEO Andrew Fish said: “We look forward to combining Horizon Discovery’s technical capabilities in reference sample development and manufacturing with MDIC’s expertise in creating and disseminating new methods and tools to advance safe and effective medical technologies.
“The Somatic Reference Samples Initiative will benefit patients by bringing more consistency to NGS-based cancer diagnostics development and ultimately support improved diagnoses and more effective treatments.”
The collaboration is part of MDIC’s SRS Initiative, which was launched this August to improve the validation and regulatory review process for NGS-based cancer diagnostics.
The Initiative also aims to create a publicly available genomic data resource library and reference samples.