Revvity Introduces New IVD Reference Standards for Monitoring Oncology Diagnostic Testing Workflows
WALTHAM, Mass.--(BUSINESS WIRE)-- Revvity, Inc. (NYSE: RVTY), today 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:
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 more information about Revvity's Mimix reference standards, please visit our website.
For In Vitro Diagnostic use. These products are only available where licensed in accordance with applicable law. Please contact your local representative for availability.
About Revvity
At Revvity, 'impossible' is inspiration, and 'can't be done' is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what's possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.
With 2024 revenue of more than $2.7 billion and approximately 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 160 countries.
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Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Professor Isabelle Fajac, in this press release, and statements regarding Vertex's beliefs about the potential benefits of ALYFTREK and TRIKAFTA for people with CF, and expectations for the pilot donation program. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. 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