NEW YORK – SpeeDx and QuantuMDx on Thursday announced a collaboration with the Foundation for Innovative New Diagnostics (FIND) to assess the feasibility of porting SpeeDx sexually transmitted infection tests to the QuantuMDx point-of-care testing device.
FIND is funding the project with an undisclosed amount.
Specifically, SpeeDx will use its proprietary PlexPCR technology to develop multiplex tests for common STIs, including gonorrhea and Mycoplasma genitalium, to be run on the QuantuMDx Q-POC device.
"QuantuMDx is always looking to expand the portfolio of diagnostic tests available on the Q-POC platform, and this collaboration with SpeeDx is an obvious choice given the proven compatibility of their robust chemistry across a range of platform technologies," Jonathan O'Halloran, CSO at QuantuMDx Group, said in a statement.
The Q-POC is a battery-operated, microfluidics-based, sample-to-answer system for low-cost molecular testing using rapid PCR followed by microarray detection.
"Patients around the globe are already benefiting from the clinically relevant information provided by SpeeDx tests, but we are cognizant that the current platforms and processes in use to run these tests do not readily translate to all regions of the world," said Elisa Mokany, SpeeDx founder and chief technology officer.
SpeeDx's commercial test kits are currently in use across Europe, Australia, and New Zealand, including its flagship ResistancePlus tests for M. genitalium and gonorrhea that include markers for antibiotic resistance and susceptibility, enabling resistance-guided therapy. The gonorrhea test, ResistancePlus GC, received FDA breakthrough designation to accelerate the process towards clearance for use in the US, and clinical trials for the M. genitalium test, ResistancePlus MG, are nearing completion with an expected US launch in early 2020.
FIND noted in a separate statement that the support is part of three awards it has granted for the development of rapid, low-cost diagnostic tests that can distinguish gonorrhea from chlamydia infections in primary care settings. The other awards have been granted to Axxin to develop a molecular POC gonorrhea test, and DCN Dx for a rapid lateral flow assay for gonorrhea.
In addition to funding, FIND is providing project support, including reference samples for rapid assay development and assessment, antibody reagents for capture and detection of N. gonorrhoeae, and technical expertise.
FIND further explained that the three projects were selected through a competitive process and proposals were assessed by an external review panel as well as FIND's scientific advisory committee. They were assessed to ensure they met a recently-published target product profile (TPP) developed by FIND and the World Health Organization for a test to identify susceptibility and resistance of gonorrhea to antibiotics, to facilitate antibiotic stewardship and prevent increased antimicrobial resistance.
"Fast diagnosis and treatment are crucial to prevent transmission and consequences of gonorrhea, but difficulties in differentiating gonorrhea and chlamydia — especially in low-resource settings that lack appropriate tests — mean that the wrong treatment is easily prescribed," said Catharina Boehme, CEO of FIND, in a statement. "This is terrible for the patient and contributes to the spread of AMR. We must urgently close this gap and provide setting-appropriate, affordable diagnostics to the communities most in need."