SpeeDx Pty. Ltd. today 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 utilizes SpeeDx market-leading PlexPCR® multiplex technology, designed for detection of 14 targets representing 10 viral respiratory-illness causing pathogens.
"We are excited to expand our infectious disease portfolio into the respiratory market," said Colin Denver, SpeeDx CEO. "SpeeDx patented technology enables multiple targets to be easily combined into a single test, which means laboratories can get results for more patients over the course of a work day compared to standard technologies. This is particularly important during the peak respiratory-testing seasons when laboratories are resource challenged."
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 impact of these respiratory pathogens is seen most heavily during late winter-early spring, with combined health and economic impacts attributed to absenteeism, hospitalization, and serious complications leading to admission in intensive care, and in some instances death. The most severe health risks are attributed to influenza illness in infants, elderly, and immune-compromised people. The 2017 Australian Flu season was particularly severe with over 233,453 reported cases of influenza (2.5 x the number reported in 2016), with almost 30,000 hospital admissions and 745 deaths - higher than any previous year to date.
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 specialize in sexually transmitted infections (STIs) and genetic mutations for antibiotic resistance. Tests include ResistancePlus® MG - clinically proven to improve cure rates for patients infected with the STI Mycoplasma genitalium (Mgen) by using antibiotic resistance information included in the test result. SpeeDx also markets ResistancePlus® GC (CE-IVD) - the first commercial test to detect Neisseria gonorrhoeae, the bacterium causing gonorrhea, and genetic markers for ciprofloxacin susceptibility, enabling doctors to treat patients with an inexpensive and simple oral antibiotic.