SpeeDx receives CE- IVD marking for PlexPCR SARS-CoV-2 assay

Australia-based innovating molecular diagnostics firm, SpeeDx has announced receiving CE-IVD marking for its two-gene PlexPCR SARS-CoV-2 assay for detecting the virus which causes novel COVID-19.

While the virus is constantly mutating and is present in different variants, medical professionals have been facing severe challenges detecting the presence of SARS-CoV-2 virus through traditional testing methods. In this case, the new robust design COVID-19 test, has been anticipated to perform well against all known virus variants.

As per credible reports, the high-throughput test is said to be highly compatible with 96- or 384-well qPCR systems and liquid handling robotics to support a streamlined and effortless laboratory workflow and meanwhile accelerating the time to result.

According to company officials, the PlexPCR SARS-CoV-2 assay marks two highly preserved regions of the virus genome. Moreover, developed and tested against a database of over 1,000,000 sequences, the performance of the assay is known to detect all circulating variants in a reduced time space.

Colin Denver, CEO of SpeeDx, while commenting on the recent accomplishment quoted that the dreaded COVID-19 pandemic has severely impacted testing laboratories throughout the world as many diagnostic supply firms have struggled to meet the testing kit demands. This is where SpeeDx comes into action.

Colin added that the company has an advantage of not needing to produce target-specific, time-consuming, and expensive testing probes. Besides, SpeeDx’s brilliant technology has allowed it to bulk produce and stockpile universal raw material, so that the company is able to fulfill the current request of its customers.

Apparently, the technology also boasts of the capacity to supply the tests to many more large-volume testing laboratories globally.

It would be essential to mention that by merging PlexPrep robotics and automated software analysis, SpeeDx is aiming to offer scalable workflows for throughputs for 480 to 1,920 patient samples within eight hours.

In fact, the company, had in March 2021, declared establishing partnership with Neogen Diagnostik for the distribution of SpeeDx ResistancePlus and PlexPCR tests.

Source Credit: https://www.medicaldevice-network.com/news/speedx-ce-ivd-test/

By Shreya Bhute

With corporate exposure in software and marketing, Shreya was always intrigued by content development. Having pursued her graduation in I.T. engineering, she works as a content writer for people.partilepep.com and jots down news articles across distinct domains including technology, business and healthcare.