FDA has granted an emergency use authorization (EUA) for the HDPCR SARS-CoV-2 real-time PCR assay from ChromaCode, Carlsbad, Calif. The assay was launched in April after validation by ChromaCode, in line with FDA’s then-current EUA regulations.


Greg Gosch, ChromaCode.

“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,” says Greg Gosch, cofounder, president, and chief executive officer of ChromaCode. “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.”

The HDPCR SARS-CoV-2 real-time PCR assay is intended to detect severe acute respiratory syndrome coronavirus 2 in nasopharyngeal swab specimens from patients suspected by their healthcare provider of having contracted covid-19. In addition to ChromaCode’s inventory guarantee, 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—with no hardware or software changes required. Onsite training is not required, as training is performed via a Web-based application.
  • Makes throughput scalable by consolidating the CDC assay into a single reaction well, so that labs can run more than 1,000 samples per qPCR instrument over a 24/7 testing period.
  • Streamlines data analysis and results management through the company’s intuitive and user-friendly software platform, ChromaCode Cloud.
  • Ensures full security and data privacy with HIPAA-compliant Cloud software that does not store protected health information.

Later this year, ChromaCode intends to leverage its unique multiplexing technology to launch a covid-19 assay that combines multiple respiratory viruses into a single test in anticipation of the upcoming flu season.

For more information, visit ChromaCode.