New Cancer Testing Standards to Improve Diagnostic Accuracy for Oncology Labs

Accurate diagnosis, including the identification of genomic markers, is essential for determining the most effective cancer treatments for patients. To ensure this, laboratories require reliable reference standards to validate and monitor their workflows effectively. Now, new IVD reference standards can provide oncology labs with trusted quality controls for optimizing tests and monitoring workflows

Revvity (Waltham, MA, USA has launched 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.

Image: Mimix Reference Standards are cell-line derived to maintain genomic complexity and mimic patient material across molecular diagnostics workflows (Photo courtesy of Revvity)

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), and Mimix Myeloid Cancer Panel, gDNA Reference Standard IVD (HD829-IVD). Leveraging 14 years of experience in developing oncology reference standards, Revvity’s Mimix controls are derived from human cell lines rather than synthetic sources, which helps maintain genomic complexity and more closely mimic patient samples.

“Accurate diagnosis, including genomic markers, is crucial in determining which cancer treatments are likely to provide patients with the best outcomes,” said Yves Dubaquie, senior vice president, diagnostics at Revvity. “To support this, labs need quality reference standards they can trust to validate and monitor workflows. Our Mimix reference standards address that need by meeting the requirements for an IVD in the U.S.”