FDA issues EUA for SARS-CoV-2 test from ChromaCode

June 11, 2020

ChromaCode announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of ChromaCode’s real time PCR Assay to detect SARS-CoV-2, according to a press release from the company.

The company’s HDPCR SARS-CoV-2 Real-Time PCR Assay is intended to detect SARS-CoV-2 from nasopharyngeal swab specimens from patients suspected by their healthcare provider of having COVID-19. Later this year, ChromaCode, based in Carlsbad, CA, also said it plans to launch an assay that combines multiple respiratory viruses into a single test.

ChromaCode’s platform is built on the use of data science technology — including proprietary signal processing techniques — and cloud-computing algorithms to boost the performance of commonly used molecular diagnostics instruments and reagents.

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