ChromaCode, a Carlsbad-based molecular diagnostics company announced that the U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) of its SARS-CoV-2 PCR Assay.
The assay was launched in April after validation by ChromaCode, in line with the FDA's EUA regulations.
ChromaCode's platform can boost the performance of commonly used molecular diagnostics instruments and reagents, powered by data science technology and cloud computing algorithms.
"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 June, ChromaCode closed a $38 million Series C funding led by Adjuvant Capital. Additional existing investors include Northpond Ventures, New Enterprise Associates, Domain Associates, Windham Ventures, Okapi Ventures, Moore Venture Partners and the California Institute of Technology.
To date, the local company has raised $50 million in venture capital and employs 40 local staffers.