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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.

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Thermo Fisher Scientific

As the world continues to contend with coronavirus and a surge in the infection rate, labs are required to run more samples than ever before. 

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Developing a fully integrated consumable cartridge for an automated diagnostic platform is a significant challenge. More challenging still is developing such a cartridge in response to a deadly global virus pandemic amid market uncertainty and extraordinary time constraints.