Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows
Revvity, Inc. announced the launch of three Mimix reference standards for IVD use, designed for monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reacting (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for IVD use.
These cell line-derived reference standards have undergone appropriate design controls to meet U.S. Food and Drug Administration (FDA) regulatory requirements, which helps laboratories integrate them into existing workflows to support monitoring test performance, assay variation, and to help identify increases in random or systemic errors.
Offering the Mimix reference standards for IVD indicates the products have been developed and manufactured in accordance with applicable quality system requirements allowing for improved reliability and precision of these reference standards.
The three Mimix reference standards cover key cancer testing applications, which include:
- Mimix OncoSpan FFPE Reference Standard IVD (HD832-IVD)
- Mimix OncoSpan gDNA Reference Standard IVD (HD827-IVD)
- Mimix Myeloid Cancer Panel, gDNA Reference Standard IVD (HD829-IVD)
For In Vitro Diagnostic use. These products are only available where licensed in accordance with applicable law.
