09 July 2021 | Friday | News
Launching at ECCMID 2021, QuantuMDx’s Q-POC™ system and its first test, a SARS-CoV-2 detection assay, are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe.
The Q-POC™ SARS-CoV-2 assay has been evaluated at St George’s, University of London, to assess clinical performance against tests in current use. The Development & Assessment of Rapid Technology (DART) Study shows 96.9% sensitivity (at CTs <35), 98.3% specificity and 0% cross reactivity with common commensal or potentially interfering organisms.
Q-POC™ is a portable PCR system which compresses an entire molecular diagnostic laboratory into a simple to use, accessible and affordable single device offering rapid, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. Q-POC™ has been designed for front-line healthcare professionals and can be used within a wide range of settings, including emergency rooms, ICU, birthing centres, clinics, and pharmacies.
The Q-POC™ SARS-CoV-2 assay is contained within a sealed, single use test cassette designed for safety, ease of use and to eliminate contamination risk. On-board reagents are also lyophilised for room temperature storage, convenient shipping and a longer shelf life.
QuantuMDx’s Q-POC™ SARS-CoV-2 Assay has been designed with the most up-to-data sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences.
Jonathan O’Halloran, Chief Executive, QuantuMDx, said: “Q-POC™ represents a new class of molecular diagnostic device: it’s fast, battery operated, can multiplex and is so simple to operate that anyone can be trained to use it. It’s a true point of care diagnostic system.
“Our Q-POC™ system is future-proof, and packs a great deal of complexity and power behind its modern lines and simple operation. Our SARS-CoV-2 test is just the first in a portfolio designed to meet real clinical needs. Over the next few years, we’ll be driving menu expansion, comprising large syndromic panels and antimicrobial resistance mutation panels, ensuring we remain at the forefront of molecular, point of care diagnostics globally.”
Sanjeev Krishna, Professor of Molecular Parasitology and Medicine at St George’s, University of London, said: “We are simply delighted to see the successful outcome of years of efforts to compress a diagnostics laboratory into a simple, portable and flexible device. The Q-POC™ platform was invented to address urgent diagnostic needs, particularly for pinch points for COVID-19 management in the NHS, and the community. In addition, how great is it to see the Northern Powerhouse delivering for us, with great potential to expand quickly and tackle other looming challenges like winter flu and antimicrobial resistance.”
Jonathan O’Halloran added: “Working with our British manufacturing partner, Cogent Technology and Singapore-based, Univac, we have scaled manufacturing to ensure security of supply for our customers and we are excited to be open for business.”
QuantuMDx was awarded £16m UK government funding in March 2020 to develop the company’s portable diagnostic testing system, Q-POC™, and disposable cassettes to allow for rapid, point-of-care testing for the SARS-CoV-2 virus in high and low-resource settings. The funding also included £3.2m towards production of QuantuMDx’ lab-based coronavirus test which is now commercially available.