QuantuMDx Group Limited, a UK-based life sciences company developing transformational point-of-care molecular diagnostics, today announced it is investing over £11 million to scale up production to mass manufacture its flagship diagnostic device, Q-POCTM and disposable test cassette.
QuantuMDx accelerated development, scale-up and manufacture of Q-POCTM – its rapid point-of-care testing system – earlier this year in response to the COVID-19 pandemic.
Q-POCTM is a portable, PCR device offering rapid, sample-to-answer, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. The Q-POCTM system comprises a sample collection kit, single-use test cassette and analyser.
The company’s first commercial assay for Q-POCTM will detect SARS-CoV-2, the virus causing COVID- 19, and Flu A & B, providing a powerful rapid PCR diagnostics and surveillance tool for clinicians and public health officials.
QuantuMDx has worked with British development partner Cambridge Design Partnership to undertake pilot manufacturing of Q-POCTM, and is now working with Cogent Technology, as the company scales for volume manufacturing.
Cogent Technology operate a 80,000 sq feet facility in Felixstowe, U.K. and have procured a new surface mount assembly line, specifically for QuantuMDx, which includes a state-of-the-art Automated Optical Inspection machine, currently the only one available in the U.K.
Rapid scale-up manufacturing of QuantuMDx’ SARS CoV-2 Flu A/B disposable test cassettes is also taking place. QuantuMDx has worked with development partner, RD Support from concept, through design and optimisation, to pilot manufacture in Denmark and design transfer to Singapore-based high volume manufacturer, Univac.
Univac is in the final stages of establishing a two million cassette production line, manufacturing component parts (injection mould tooling) undertaking assembly and inspection, as well as validating the production line, processes and equipment. Univac will manufacture the first batch of test cassettes in early 2021.
QuantuMDx expects to achieve CE-IVD marking for its Q-POCTM system in early 2021, following a release for research use only.
Jonathan O’Halloran, Chief Executive, QuantuMDx, said:
“We have developed the Q-POCTM over the past 10 years and created one of the fastest, most accurate and powerful PCR diagnostic devices on the market, and at the right time to be able to respond to the pandemic. We have spent the last 10 months scaling our manufacturing for both our Q-POCTM and first commercial test cassette and are presently running performance evaluation studies to confirm performance in real-life clinical settings.
“We’re delighted to be working with Univac, RD Support and fellow British partners, Cogent and CDP to support the international response to COVID-19 testing. Scaling-up was always going to be a challenge, especially during a global pandemic, but with the commitment, focus and dedication of everyone involved with QuantuMDx and our partners, we’ll soon be able to introduce our rapid, point of care diagnostic solution to benefit front line health workers, across the globe. With the large manufacturing scale that we have achieved, QuantuMDx is poised to become an important player in the molecular diagnostics industry.”