ChromaCode, Carlsbad, Calif, has launched the HDPCR SARS-CoV-2 real-time PCR assay. The assay has been validated by ChromaCode, and an independent review of the validation data by FDA is pending. Consistent with FDA policy, the test is being launched concurrent with FDA’s review for emergency use authorization.

The HDPCR SARS-CoV-2 assay is intended to detect SARS-CoV-2 in  nasopharyngeal swab specimens from patients suspected by their healthcare provider of having contracted covid-19. The assay consolidates the 2019 novel coronavirus real-time reverse transcriptase PCR diagnostic panel developed by the US Centers for Disease Control and Prevention from three reaction wells to one reaction well, increasing test throughput by a factor of three.

Greg Gosch, ChromaCode.

Greg Gosch, ChromaCode.

The test can be run on the Applied Biosystems 7500 Fast Dx real-time PCR system, the Applied Biosystems QuantStudio 7 analyzer, and other instruments, without requiring any software or hardware updates. HDPCR SARS-CoV-2 results are analyzed in ChromaCode’s HIPAA-compliant Cloud-based software, ChromaCode Cloud.

“We’re excited to be offering a higher-throughput PCR test to support the SARS CoV-2 testing needs of hospitals and clinical reference labs,” says Greg Gosch, ChromaCode’s cofounder, president, and chief executive officer. “I am grateful to the entire ChromaCode team for quickly marshaling efforts to meet the extraordinary demands of the covid-19 pandemic.”

High-definition PCR is the coupling of widely used, low-cost chemistries with ChromaCode’s proprietary data science algorithms. HDPCR seamlessly integrates with common real-time and digital PCR platforms and allows for the development of enhanced multiplexing levels without any hardware changes.

For more information, visit ChromaCode.