QuantuMDx invests £11 million on scale-up to mass manufacture
17th December 2020 | QuantuMDx Team
NEWCASTLE UPON TYNE, UK, 17 December 2020. QuantuMDx today announced it has invested over £11 million to scale up production of its flagship diagnostic device, Q-POC™ and disposable test cassette, to mass manufacture.
QuantuMDx 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.
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 Q-POC™ 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, 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-POC™, 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-POC™ system in early 2021, following a release for research use only.
Jonathan O’Halloran, Chief Executive, QuantuMDx, said:
“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.
“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.”
Debra Daglish, Marketing Communications Manager, QuantuMDx Group Limited
Chris Gardner, Matthew Neal and Lindsey Neville, Consilium Strategic Communications – firstname.lastname@example.org
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