ChromaCode’s Emergency Use Authorization (EUA) Expanded by FDA for High-Throughput HDPCR™ SARS-CoV-2 Real-Time PCR Assay

Excerpt from the Press Release:

CARLSBAD, Calif.–(BUSINESS WIRE)–ChromaCode, Inc., a company redefining molecular testing through data science, announced today 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.

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