Waltham, Mass. — Revvity, Inc. has launched its first set of Mimix reference standards developed specifically for in vitro diagnostic (IVD) use, marking a significant step forward in quality control for oncology diagnostics. The new standards are designed to support diagnostic laboratories using next-generation sequencing (NGS) and droplet digital PCR (ddPCR) assays to detect somatic mutations in genomic DNA from human samples.
The company announced the release of three reference products—Mimix OncoSpan FFPE Reference Standard, Mimix OncoSpan gDNA Reference Standard, and Mimix Myeloid Cancer Panel gDNA Reference Standard. These tools aim to help labs monitor assay performance, detect variation, and identify systemic or random errors in testing workflows.
According to Yves Dubaquie, Senior Vice President of Diagnostics at Revvity, the availability of high-quality reference standards is critical in ensuring accurate cancer diagnoses and personalized treatment plans. “Accurate diagnosis, including genomic markers, is crucial in determining which cancer treatments are likely to provide patients with the best outcomes,” he said. “Our Mimix reference standards address that need by meeting the requirements for an IVD in the U.S.”
Revvity’s Mimix standards have been developed under design controls that comply with FDA regulatory guidelines, ensuring they can be reliably integrated into clinical diagnostic workflows. Unlike synthetic alternatives, these reference standards are derived from human cell lines, helping preserve genomic complexity and more accurately mimic real patient samples.
The launch reflects Revvity’s continued investment in oncology diagnostics, building on more than a decade of experience in developing reference materials. With the introduction of these FDA-compliant tools, the company aims to improve precision, consistency, and reliability in cancer testing across a range of clinical settings.
