Tuesday, 19 March 2019

SpeeDx submits RespiVirus assay for clinical approval

13 February 2019 | News

SpeeDx PlexPCR RespiVirus offers excellent sensitivity and improved productivity for fast and reproducible respiratory virus testing.

SpeeDx Pty. Ltd. has announced submission of their PlexPCR® RespiVirus test to the Therapeutic Goods Administration (TGA). The company anticipates clearance in time for the Australian 2019 flu season. The test utilises SpeeDx market-leading PlexPCR® multiplex technology, designed for detection of 14 targets representing 10 viral respiratory-illness causing pathogens.

The SpeeDx PlexPCR RespiVirus test detects major respiratory pathogens including Influenza A, Influenza B, Rhinoviruses (A & B), Respiratory Syncytial Viruses (A & B), Human metapneumovirus, Adenoviruses, and Human parainfluenza viruses 1, 2, 3 and 4.

The anticipated addition of PlexPCR RespiVirus will add to SpeeDx’s infectious disease test portfolio that includes PlexPCR® VHS, a multiplex lesion diagnostic test for Herpes Viruses (Type-1 & -2); Varicella Zoster Virus, responsible for causing chicken pox and shingles; and Treponema pallidum, the bacterium that causes syphilis. Other tests in the SpeeDx portfolio specialise in sexually transmitted infections (STIs) and genetic mutations for antibiotic resistance.

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