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ChromaCode Receives FDA Emergency Use Authorization for SARS-CoV-2 PCR Test

NEW YORK – Software and reagent technology firm ChromaCode announced Wednesday its HDPCR SARS-CoV-2 Real-Time PCR assay received Emergency Use Authorization from the US Food and Drug Administration.

The test detects the virus from nasopharyngeal swab specimens and runs on standard qPCR instruments, including Thermo Fisher Scientific's Applied Biosystems 7500 Fast machine. Labs can run more than 1,000 samples per qPCR instrument in 24 hours, the firm said.

ChromaCode Co-founder, President, and CEO Greg Gosch added in a statement that the firm "guarantees ongoing supply for customers who sign an agreement" with it. Later this year, the firm said it will launch a SARS-CoV-2 test combining multiple respiratory viruses into a single test in preparation for the upcoming flu season. 

According to the Carlsbad, California-based company, it uses data science technology and cloud-computing algorithms to boost performance of common molecular diagnostic instruments and reagents, and its high-definition PCR technology expands the number of detectable disease targets in a single reaction.

Last month, the firm announced it had raised a total of $38 million in a Series C financing round, which it will use to continue developing the HDPCR platform and further its global expansion in resource-limited communities.