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FDA Expands EUA for High-Throughput SARS-CoV-2 Real-Time PCR Assay

by | Mar 3, 2022 | Articles, News, Open Content

CARLSBAD, CA — ChromaCode, Inc., a company redefining molecular testing through data science, announced on Feb. 23 that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than quadruple throughput […]

CARLSBAD, CA — ChromaCode, Inc., a company redefining molecular testing through data science, announced on Feb. 23 that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than quadruple throughput for laboratories.

“Our high-throughput PCR assay combined with our unique ChromaCode Cloud has enabled our customers to run massive test volumes with high reliability and confidence,” said Alex Dickinson, ChromaCode’s co-founder and CEO. “The EUA authorization for use with even more instrument platforms and 384-well plates will enable labs using ChromaCode’s assay to continue to rapidly scale and meet the demand for high-volume testing while delivering excellent accuracy and variant inclusivity.”

ChromaCode’s HDPCR SARS-CoV-2 Assay is now compatible with industry leading extraction and amplification systems. The Thermo Fisher Scientific™ Kingfisher™ Flex Purification System can be used in conjunction with Thermo Fisher PCR instruments including QuantStudio™ 5, QuantStudio™ 7, QuantStudio™ 12K Flex, ABI 7500 Fast, and ABI 7500 Fast Dx. This wide selection of PCR instrumentation allows labs to use a familiar workflow and reagents for a seamless adoption of the ChromaCode test. Additionally, the QuantStudio platform gives labs the flexibility to run either 96- or 384-well plates potentially quadrupling the number of COVID tests in a single run. Use of standard PCR instruments with efficient workflows, and a competitive price per test, ensures labs have cost-effective solutions for unpredictable test demand.

“We have consistently delivered a cost-effective, scalable, and proven COVID product to a strong customer base,” said Dickinson. “Our use of traditional PCR chemistry components enable scalable production and the ability to meet ever-changing customer needs during the pandemic. The expansion of the EUA allows our customers to improve efficiencies while providing affordable, confident PCR results.”

This press release was provided by ChromaCode, Inc.

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