Sunday, 16 June 2019

TGA approves SpeeDx Respiratory Virus Test

14 May 2019 | News

Highly multiplexed test offers workflow advantages to support the Flu season surge

SpeeDx Pty. Ltd. has announced the clearance of the PlexPCR® RespiVirus* test from the Australian Therapeutic Goods Administration (TGA). The test utilises market-leading PlexPCR® technology to detect 11 viral respiratory-illness causing pathogens and allows laboratories to process more samples in an 8-hour shift compared to standard in-house test methods. The respiratory virus test includes automated reporting software to further improve laboratory productivity and speed up result reporting processes.

“We are so pleased to be in a position to support Australian laboratories for what is already proving to be a very busy flu season,” said Colin Denver, SpeeDx CEO. “The workflow advantages afforded by PlexPCR® RespiVirus means more patient results can be reported over the course of a work day compared to standard technologies.”

The SpeeDx PlexPCR RespiVirus test detects important respiratory pathogens including Influenza A, Influenza B, Rhinovirus, Respiratory Syncytial Viruses (A & B), Human metapneumovirus, Adenovirus, and Human parainfluenza viruses 1, 2, 3 and 4. Results from the test can assist in appropriate patient care and community/outbreak management. The addition of PlexPCR RespiVirus to SpeeDx’s infectious disease test portfolio broadens the testing menu from the current suite of tests for sexually transmitted infections and antimicrobial resistance markers that include ResistancePlus® MG* and ResistancePlus® GC* – supporting Resistance Guided Therapy for Mycoplasma genitalium and gonorrhoea respectively – and PlexPCR® VHS*, a multiplex lesion diagnostic test.

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