QuantuMDx, Newcastle Upon Tyne, UK, 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—in 2020 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 analyzer.

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 operates an 80,000-square-foot facility in Felixstowe, UK and has 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 UK.

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 optimization, 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 mold 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.

Featured image: QuantuMDx Q-POC (Courtesy: QuantMDx)