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Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows

12 Jun 2025

Product news

Revvity, Inc. has 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.

“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.”

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:

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.

For In Vitro Diagnostic use. These products are only available where licensed in accordance with applicable law. Please contact your local representative for availability.

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Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.ddPCRCancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.OncologyThe branch of medical science that deals with the diagnosis and treatment of cancer is known as oncology.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.Precision MedicinePrecision medicine refers to the idea of customized healthcare, where medical decisions and treatments are tailored to the individual patient. Molecular diagnostics, companion diagnostics and Next Generation Sequencing (NGS) play a pivotal role in this approach. GenomicsGenomics is the study of genomes, focusing on the sequencing, analysis, and interpretation of genetic material. It is key in understanding genetic diseases, evolutionary biology, and personalized medicine. Techniques like next-generation sequencing (NGS) are commonly used in genomics research. Browse our peer-reviewed product directory to find the best genomics tools, compare products, check reviews, and get pricing directly from manufacturers.

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