SpeeDx obtains CE-IVD mark for two-gene SARS-CoV-2 test
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SpeeDx obtains CE-IVD mark for two-gene SARS-CoV-2 test

27 Apr 2021 (Last Updated April 27th, 2021 12:52)

SpeeDx has received CE-IVD marking for its two-gene PlexPCR SARS-CoV-2 assay for identifying the SARS-CoV-2 virus that causes Covid-19.

SpeeDx obtains CE-IVD mark for two-gene SARS-CoV-2 test
The assay targets the RdRp and ORF1ab conserved regions of the SARS-CoV-2 genome to detect all known circulating variants of the virus. Credit: Belova59 from Pixabay.

SpeeDx has received CE-IVD marking for its two-gene PlexPCR SARS-CoV-2 assay for identifying the SARS-CoV-2 virus that causes Covid-19.

Targeting the RdRp and ORF1ab conserved regions of the SARS-CoV-2 genome, the assay can detect all known circulating variants of the virus.

To guarantee the identification of new and emerging SARS-CoV-2 variants, regular computer-based analysis is carried out, which can detect variants without requiring confirmatory testing.

The PlexPCR SARS-CoV-2 assay has been tested against a database of more than one million sequences.

The high-throughput test is compatible with 96-well or 384-well qPCR systems and liquid handling robotics, which will aid in providing simpler laboratory workflows and reducing the time to result.

SpeeDx CEO Colin Denver said: “The Covid-19 pandemic has impacted testing laboratories throughout the world as many diagnostic supply companies have struggled to meet testing needs.

“SpeeDx has the advantage of not needing to manufacture target-specific, expensive and time-consuming testing probes.

“Our unique technology has allowed us to bulk produce and stockpile universal raw materials, so we are able to rapidly fulfil all our current customers’ orders while having the capacity to supply many more large-volume testing laboratories.”

The PlexPC SARS-CoV-2 assay has compatible workflow with the PlexPCR RespiVirus test, a two-well multiplex assay for detecting 14 targets from 11 viral respiratory-illness causing pathogens such as Influenza A, Influenza B and Respiratory Syncytial Viruses (A & B).

Furthermore, these respiratory tests are also compatible with the compact and cost-efficient liquid handling system SpeeDx PlexPrep.

By merging PlexPrep robotics and automated software analysis, SpeeDx can offer scalable workflows for throughputs of 480 to 1,920 patient samples in eight hours.

Last month, SpeeDx and Neogen Diagnostik collaborated to distribute SpeeDx ResistancePlus and PlexPCR tests.

As per the agreement, Neogen Diagnostik will deal with the distribution of all SpeeDx tests in Turkey.