ChromaCode, Inc., a company redefining molecular testing through data science, today announced the launch of 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 the U.S. Food and Drug Administration is pending. Consistent with FDA policy, the test is being launched concurrent with FDA’s review for Emergency Use Authorization.
The SARS-HDPCR CoV-2 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. The assay consolidates the Centers for Disease Control and Prevention’s 2019-Novel Coronavirus Real-Time Reverse Transcriptase PCR Diagnostic Panel from 3 reaction wells to 1 reaction well, increasing test throughput by 3x and can be run on the Applied Biosystems™️ 7500 Fast, and QuantStudio™️ 7 without requiring any software or hardware updates. HDPCR SARS-CoV-2 results are analyzed in ChromaCode’s HIPAA-compliant cloud-based software, ChromaCode Cloud™, which provides laboratories with an end-to-end solution to streamline test workflow and results interpretation.
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“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,” said Greg Gosch, ChromaCode’s Co-founder, President and CEO. “I am grateful to the entire ChromaCode team for quickly marshalling 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 onto common real-time and digital PCR platforms and allows for development of enhanced multiplexing levels without any hardware changes.
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