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August 12, 2021

Australian TGA approves SpeeDx SARS-CoV-2 test

The two-gene PlexPCR assay targets the RdRp and ORF1ab conserved regions of the SARS-CoV-2 genome.

SpeeDx has received approval from the Australian Therapeutic Goods Administration (TGA) for its PlexPCR SARS-CoV-2 test.

The latest move follows the assay’s receiving CE-IVD marking in April.

The two-gene, single-well test targets two conserved regions, RdRp and ORF1ab, of the SARS-CoV-2 genome and detects all current circulating variants of the virus with scalable 96-well or 384-well capacity.

SpeeDx stated that the PlexPCR SARS-CoV-2 assay has been tested against a database of more than 1,000,000 sequences.

The test combines automated software analysis and liquid handling robotics in the form of the PlexPrep robotics, supporting 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.”

The addition of the new Covid-19 test expands the company’s respiratory testing menu, which currently includes PlexPCR RespiVirus, a two-well multiplex assay.

The PlexPCR RespiVirus test detects 14 targets from 11 viral respiratory-illness causing pathogens, such as Influenza A, Influenza B and Respiratory Syncytial Viruses (A & B).

SpeeDx ’s tests can also check for sexually transmitted infections and antimicrobial resistance, including ResistancePlus MGr and ResistancePlus GC, which support resistance guided therapy for Mycoplasma genitalium and gonorrhoea, respectively.

It also has PlexPCR VHS, a multiplex lesion diagnostic test, which detects and differentiates common lesion-causing pathogens Herpes simplex virus (HSV-1&-2), Varicella zoster virus (VZV) and Treponema pallidum (Syphilis) in a single-well multiplex qPCR test.


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