ChromaCode's High-Throughput HDPCR SARS-CoV-2 Real-Time PCR Assay Granted FDA Emergency Use Authorization

ChromaCode, Inc. (Carlsbad, CA, USA) has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its HDPCR SARS-CoV-2 Real-Time PCR Assay which had been launched in April.

The HDPCR SARS-CoV-2 Real-Time PCR Assay is intended to detect severe acute respiratory syndrome coronavirus 2 from nasopharyngeal swab specimens from patients suspected by their healthcare provider of having contracted COVID-19. The company's HDPCR SARS-CoV-2 Real-Time PCR Assay enables frictionless adoption by running on standard qPCR instruments, including the Applied Biosystems 7500 Fast, QuantStudio 7 and QuantStudio 12K, without the requirement for any hardware or software changes. It makes throughput scalable by consolidating the CDC assay into a single reaction well so that laboratoroies can run 1,000+ samples per qPCR instrument over a 24/7 testing period. Later this year, ChromaCode intends to leverage its unique multiplexing technology to launch a COVID assay that combines multiple respiratory viruses into a single test in anticipation of the upcoming flu season.


"Customers continue to experience extraordinary increases in testing volume; our ability to enable labs to process thousands of samples in one day using existing laboratory equipment means they can rapidly scale testing to meet high demands," said Greg Gosch, ChromaCode's Co-founder, President and CEO. "With testing volumes continuing to grow, it is important that institutions have continued access to the inventory they need, so they don't experience the disruption of moving to a different test. To address this, ChromaCode guarantees ongoing supply for customers who sign an agreement with us."