TGA approval for SpeeDx COVID-19 diagnostic test

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The TGA has approved the COVID-19 diagnostic test developed by the Australian company SpeeDx.

The company said the test was designed from a database of over 1,000,000 sequences. The two-gene, single-well test detects all current circulating variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The test is ideally suited to support rapid response to outbreaks, offering scalable 96- or 384-well capacity, automated software reporting, and liquid handling robotics in the form of the SpeeDx PlexPrep, said the company.

It said the combination of PlexPrep robotics and automated software analysis can support a scalable workflow for throughputs of 480 to 1,920 patient samples in an 8-hour shift.

Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe.

“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,” said Colin Denver, SpeeDx CEO.

“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.”

SpeeDx also recently launched the PlexPrime SARS-CoV-2 Genotyping portfolio, a range of research reagents supporting laboratory and epidemiological investigations of SARS-CoV-2 newly circulating variants.