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Mimix™ reference standards for IVD

Revvity, Inc. has introduced three new Mimix™ reference standards for IVD (In Vitro Diagnostic) use, designed to significantly bolster the reliability of next-generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays. These assays are crucial for detecting somatic mutations in genomic DNA (gDNA) from human samples, particularly in oncology. The newly launched standards—comprising the 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)—are uniquely derived from human cell lines, ensuring they more accurately mimic the genomic complexity of patient samples compared to synthetic alternatives. Developed and manufactured under stringent design controls to meet U.S. FDA regulatory requirements, these reference standards are engineered for seamless integration into existing laboratory workflows. This allows laboratories to more effectively monitor test performance, assess assay variation, and promptly identify any increases in random or systemic errors, thereby ensuring the highest level of precision and reliability in genomic testing, which is paramount for guiding accurate cancer treatment decisions and ultimately improving patient outcomes.

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