SpeeDx Receives Clearance for COVID-19 Diagnostic Test

Robust, dual-target test now available for sale in Australia

SYDNEY--(BUSINESS WIRE)-- SpeeDx Pty. Ltd. announced today their PlexPCR^® SARS-CoV-2* test received clearance from the Australian Therapeutic Goods Administration (TGA). 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 causative agent of COVID-19. 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™. 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.

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The dual-gene, single-well test detects all current circulating variants with scalable capacity - utilising automated software and compatible with liquid handling robotics. Ideal to support surges in test demand with throughputs of up to 1,920 patient samples in an 8 hour shift.

“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.”

The addition of PlexPCR^® SARS-CoV-2 expands SpeeDx’s respiratory testing menu that includes PlexPCR^® RespiVirus* - a two-well multiplex assay for the detection of 14 targets from 11 viral respiratory-illness causing pathogens including Influenza A, Influenza B, and Respiratory Syncytial Viruses (A & B). A respiratory bacteria is also planned to further build SpeeDx’s respiratory infectious disease test portfolio.

SpeeDx recently leveraged their unique mutation detection approach to launch the PlexPrime^® SARS-CoV-2 Genotyping portfolio, a range of research reagents supporting laboratory and epidemiological investigations of SARS-CoV-2 newly circulating variants. Investigations connected to Variants of Concern (VOC) show evidence of increased transmissibility, reduced vaccine efficacy, and other attributes that may require specific public health actions.¹ There are also emerging Variants of Interest (VOI) appearing in increased proportions or in outbreak clusters. SpeeDx proprietary PlexPrime^® and PlexZyme^® technology allows for mutation-specific amplification and detection – a highly sensitive approach that can also simultaneously analyse multiple mutations. Current practices involve multiple-well tests or sequencing analysis, all of which extend the turn-around-time to result. SpeeDx advanced multiplex technology reduces the number of wells required, resulting in a simplified process with increased throughput to accelerate turnaround of variant investigations.

The addition of PlexPCR^® SARS-CoV-2 and associated products broadens SpeeDx’s available 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.

*not available in the U.S.

^§based on in silico investigation as of August 2021

About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with offices in London and the US, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. SpeeDx has a portfolio of CE-IVD kits for detection of infectious disease pathogens, sexually transmitted infection (STI), and antimicrobial resistance markers. SpeeDx ResistancePlus tests enable Resistance Guided Therapy, improving patient outcomes by empowering practitioners to make informed clinical decisions.

For more information about SpeeDx please see: http://plexpcr.com

References

1. Centers for Disease Control and Prevention, SARS-CoV-2 Variant Classifications and Definitions. found at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html last updated May 17, 2021.

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