SpeeDx, a provider of molecular diagnostic solutions, has received the Australian Therapeutic Goods Administration (TGA) approval for its PlexPCR SARS-CoV-2 test.

The two-gene, single-well test has been designed using a database of more than 1,000,000 sequences to detect all current variants of SARS-CoV-2, the virus that causes Covid-19.

It supports a rapid response to outbreaks and offers scalable 96- or 384-well capacity, automated software reporting and liquid handling robotics in the form of the SpeeDx PlexPrep, said the company

Also, the PlexPrep robotics in combination with automated software analysis offers a scalable workflow for throughputs of 480 to 1,920 patient samples in eight hours.

SpeeDx CEO Colin Denver said: “We have been supporting labs around the world with their Covid-19 testing needs, and we are very happy to extend that service to our local healthcare providers.

“Throughout the pandemic, labs across Australia faced supply challenges from many of the global diagnostic providers, and we are passionate about improving sovereign capacity in this space.”

With the addition of PlexPCR SARS-CoV-2, SpeeDx is enabled to expand its respiratory testing menu that includes PlexPCR RespiVirus.

PlexPCR RespiVirus is a two-well multiplex assay designed to detect 14 targets from 11 respiratory viruses including Influenza A, Influenza B and Respiratory Syncytial Viruses.

Also, the company intends to add respiratory bacteria to further enhance its respiratory infectious disease test portfolio.

SpeeDx has recently leveraged its mutation detection approach to launch the PlexPrime SARS-CoV-2 Genotyping portfolio.

The portfolio includes research reagents that support laboratory and epidemiological investigations of SARS-CoV-2 newly circulating variants.

Furthermore, SpeeDx has widened its available testing menu with a suite of tests for sexually transmitted infections and antimicrobial resistance markers.

The tests include ResistancePlus MG† that supports therapy for Mycoplasma genitalium and ResistancePlus GC† for gonorrhoea, and PlexPCR VHS†, a multiplex lesion diagnostic test.