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FDA Authorizes Real-Time PCR Assay for COVID-19

ChromaCode now intends to use its own multiplexing technology to help launch a COVID-19 assay later this year. The assay would combine multiple respiratory viruses into a single test in anticipation of the upcoming flu season.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to ChromaCode’s HDPCR SARS-CoV-2 Real-Time PCR Assay.

The assay authorization grants the company utility for the device’s purpose of detecting SARS-CoV-2 from nasopharyngeal swab specimens from patients suspected by their healthcare providers of having contracted coronavirus 2019 (COVID-19).

ChromaCode now intends to use its own multiplexing technology to help launch a COVID-19 assay later this year. The assay would combine multiple respiratory viruses into a single test in anticipation of the upcoming flu season.

The company’s assay platform runs on standard qPCR instruments with no required hardware/software changes, and provides a US Centers for Disease Control and Prevention (CDC) assay consolidated into a single reaction well—allowing labs to run 1000-plus samples per qPCR instrument over a 24/7 testing period.

"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," Greg Gosch, ChromaCode's Co-founder, president and chief executive officer, said in a statement. "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.”

As such, the company is guaranteeing ongoing supply for customers who sign an agreement, Gosch said.