The HDPCR SARS-CoV-2 assay detects severe acute respiratory syndrome coronavirus 2 from nasopharyngeal swab specimens. Credit: Diverse Stock Photos / Flickr (Creative Commons).

The US Food and Drug Administration (FDA) has expanded ChromaCode’s HDPCR SARS-CoV-2 real-time PCR assay emergency use authorisation (EUA).

ChromaCode’s assay is designed for the detection of severe acute respiratory syndrome coronavirus 2 from nasopharyngeal swab specimens collected from individuals who are suspected of Covid-19 by their healthcare provider.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The expanded approval for the assay includes the addition of many new qPCR instruments, as well as the use of 384-well plates.

Now, the HDPCR SARS-CoV-2 assay is compatible with amplification and extraction systems.

The results from the assay are analysed in ChromaCode Cloud, the company’s HIPAA-compliant Cloud-based software.

ChromaCode Cloud provides an end-to-end solution for laboratories to streamline the test workflow and interpretation of results.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

The Thermo Fisher Scientific Kingfisher Flex Purification System can be used alongside Thermo Fisher PCR instruments that include ABI 7500 Fast, ABI 7500 Fast Dx, QuantStudio 5, QuantStudio 7 and QuantStudio 12K Flex.

ChromaCode stated that the QuantStudio platform provides flexibility for labs to run either 96-well or 384-well plates to quadruple many Covid tests in a single run.

With this broad PCR instrumentation selection, labs will also be able to use known workflows and reagents to adopt the ChromaCode test.

ChromaCode co-founder and CEO Alex Dickinson said: “Our high-throughput PCR assay combined with our unique ChromaCode Cloud has enabled our customers to run massive test volumes with high reliability and confidence.

“The EUA authorisation for use with even more instrument platforms and 384-well plates will enable labs using ChromaCode’s assay to continue to rapidly scale and meet the demand for high-volume testing while delivering excellent accuracy and variant inclusivity.”

Medical Device Network Excellence Awards - The Benefits of Entering

Gain the recognition you deserve! The Medical Device Network Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving medical devices advancements. Don’t miss your chance to stand out—submit your entry today!

Nominate Now