QuantuMDx invests millions on scale-up to mass manufacture

The company accelerated development, scale-up and manufacture of Q-POC – its rapid point-of-care testing system – earlier this year in response to the COVID-19 pandemic. The Q-POC 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 system comprises a sample collection kit, single-use test cassette and analyser. The company’s first commercial assay for Q-POC will detect SARS-CoV-2, the virus causing COVID-19, and Flu A & B. QuantuMDx has worked with British development partner Cambridge Design Partnership to undertake pilot manufacturing of Q-POC, and is now working with manufacturer Cogent Technology, as the company scales for volume manufacturing. Cogent Technology operate a 80'000 square feet facility in Felixstowe, U.K. and have procured a new surface mount assembly line, specifically for QuantuMDx, which includes an automated optical inspection machine, currently the only one available in the U.K, a press release reads. 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. QuantuMDx expects to achieve CE-IVD marking for its Q-POC system in early 2021, following a release for research use only. "We have developed the Q-POC 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-POC and first commercial test cassette and are presently running performance evaluation studies to confirm performance in real-life clinical settings," says Jonathan O’Halloran, Chief Executive, QuantuMDx, in the press release. “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,” O’Halloran concludes.