ChromaCode Gets Expanded EUA for COVID-19 Assay

ChromaCode has been awarded an expanded Emergency Use Authorization (EUA) by the FDA for its COVID-19 test, the HDPCR SARS-CoV-2 assay.

The expanded EUA for the real-time polymerase chain-reaction (PCR) test includes the use of several quantitative PCR instruments that amplify and detect the viral DNA and 384-well plates, which can more than quadruple throughput for laboratories, according to the Carlsbad, Calif.-based company.

The qualitative PCR assay also includes broad coverage of relevant SARS-CoV-2 variants and is compatible with other companies’ widely used extraction and amplification systems, the company said.