ChromaCode announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of ChromaCode's HDPCR™ SARS-CoV-2 Real-Time PCR Assay. The assay was launched in April after validation by ChromaCode, in line with the FDA's EUA regulations.
"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."
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. 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.
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/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 labs can run 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 (PHI).