Revvity breaks new ground with FDA-approved reference standards for precision oncology
Cancer diagnostics laboratories have gained a powerful new tool in the fight against genomic complexity. Revvity has unveiled its first FDA-compliant IVD Mimix reference standards, engineered to revolutionise quality control in next-generation sequencing and droplet digital PCR workflows for oncology applications.
Genomic authenticity drives diagnostic precision
Breaking away from synthetic alternatives, Revvity’s approach harnesses the power of human cell line-derived materials to maintain authentic genomic complexity. This strategic innovation creates reference standards that truly mirror patient samples, addressing a critical gap in molecular diagnostics quality control.
“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 meetingthe requirements for an IVD in the U.S.”
The breakthrough leverages 14 years of accumulated expertise in oncology reference standard development, positioning Revvity at the forefront of precision medicine quality assurance.
Comprehensive molecular oncology toolkit
Three distinct reference standards target diverse cancer testing applications:
• Mimix OncoSpan FFPE Reference Standard IVD (HD832-IVD) addresses the complexities of formalin-fixed, paraffin-embedded tissue analysis – a cornerstone of histopathological diagnosis.
• Mimix OncoSpan gDNA Reference Standard IVD (HD827-IVD) provides genomic DNA quality control for comprehensive mutation detection protocols.
• Mimix Myeloid Cancer Panel gDNA Reference Standard IVD (HD829-IVD) specifically targets haematological malignancies, enabling precise monitoring of complex genetic alterations.
Regulatory compliance transforms laboratory workflows
The FDA regulatory approval represents a significant milestone for diagnostic laboratories. These reference standards undergo rigorous design controls to meet stringent regulatory requirements, enabling seamless integration into existing workflows whilst supporting critical quality metrics.
Laboratories can now monitor test performance, assess assay variation, and identify systematic errors with unprecedented confidence. The IVD designation ensures products meet applicable quality system requirements, delivering enhanced reliability and precision compared to research-use alternatives.
Transforming cancer diagnostic precision
This launch addresses the growing demand for robust quality control measures as precision oncology expands across clinical practice. The ability to detect somatic mutations with consistent accuracy becomes increasingly critical as targeted therapies depend on precise genomic characterisation.
For more information, visit: www.revvity.com
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