December 18, 2020 @ 11:58 by Richard Dawson
A Newcastle-based life sciences company has invested more than £11 million to scale up production of its diagnostic Q-POC™ device and disposable test cassette.
QuantuMDx accelerated the development, scale-up, and manufacture of its molecular diagnostic system earlier in the year as a response to the COVID-19 pandemic.
Q-POC™ is a portable, point-of-care PCR device providing rapid molecular diagnostic testing for clinicians and public health officials, giving results in approximately 30 minutes.
The system comprises a sample collection kit, a single-use test cassette, and an analyser.
The first commercial assay for Q-POC™ will detect SARS-CoV-2, the virus responsible for COVID-19, as well as Flu A and B.
QuantuMDx worked with British development partner Cambridge Design Partnership (CDP) to carry out pilot manufacturing of Q-POC™.
The company is now working with Cogent Technology to scale up and prepare for mass manufacturing of the device, and have procured a new surface mount assembly line specially designed for QuantuMDx at Cogent Technology’s 80,000 sq foot facility in Felixstowe, UK.
The assembly line includes the UK’s only state-of-the-art Automated Optical Inspection machine.
QuantuMDx have also worked with development partner RD Support to design, optimise, and pilot manufacture the CoV-2 Flu A/B disposable test cassettes.
The design has been transferred to Singapore-based Univac, which is now rapidly scaling up the manufacturing of the cassettes.
Univac is in the final stages of creating a two million cassette production line and expects to manufacture the first batch of cassettes in early 2021.
QuantuMDx hope to achieve CE-IVD marking for the Q-POC™ system early next year.
Jonathan O’Halloran, chief executive of 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.”