Summary:
Revvity, Inc. has launched three FDA-compliant Mimix reference standards for in vitro diagnostic (IVD) use, aimed at enhancing the accuracy and reliability of NGS and ddPCR assays for detecting somatic mutations in cancer testing.

Takeaways:

  1. The Mimix standards are cell line-derived, maintaining genomic complexity to better simulate real patient samples.
  2. Designed to meet FDA regulatory requirements, the standards support assay performance monitoring and error detection.
  3. The three products target key cancer applications, including FFPE, general gDNA, and myeloid cancer panels.

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 workows 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,” says Yves Dubaquie, senior vice president, diagnostics at Revvity. “To support this, labs need quality reference standards they can trust to validate and monitor workows. Our Mimix reference standards address that need by meeting the requirements for an IVD in the U.S.”

Mimix Reference Standards Allow for Improved Reliability and Precision

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)

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 IVD Use

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

Featured Image: Revvity has announced the launch of three Mimix reference standards for IVD use, designed for monitoring of NGS or ddPCR assays designed to detect somatic mutations in gDNA from human samples for IVD use. Image: Revvity