Citylabs-based molecular diagnostics group Yourgene Health has expanded its lab capabilities to offer COVID-19 testing service and is developing its own COVID-19 test kit and targeting a pipeline of opportunities.
Its COVID-19 testing service will support private testing demand where there are defined testing populations, such as UK GP surgeries, private clinics and other corporate clients across UK.
The company announces is also currently developing its first infectious disease test called Clarigene SARS-CoV-2 test – a molecular PCR based COVID-19 test which is able to detect whether individuals are currently infected.
The test has produced preliminary data which the directors believe show competitive performance compared with other market-leading products, and also has a rapid turnaround time and low false negative results.
Yourgene aims to release a “research use only” version of its test by the end of June and a CE-marked in vitro diagnostic kit to follow in July.
The test will initially be a manual assay and development has commenced with a fully automated version aimed at high throughput laboratories to follow in the coming months.
Yourgene already has more than 300 laboratory customers and a growing global network of distribution channels in place through which to drive sales of the new Clarigene infectious disease portfolio of products. In addition, the test will be run in the Yourgene service laboratory once it is launched as a CE IVD kit.
The company said it continues to explore additional opportunities to expand its contribution to global COVID-19 testing efforts with increased usage of its state-of-the-art manufacturing facility at Citylabs in Manchester, as well as exploring additional routes to market.
In a trading update this morning, the company said its core molecular diagnostics business continues to perform in line with management expectations and remains on track to build on the strong year end performance announced in the trading update for the year ended March 31, 2020.
It said it remains confident of receiving CE marking for its Illumina-based IONA test in the near future and has been informed that the product has now been recommended for approval and is in the final stages of evaluation.
Yourgene will announce results for the year ended March 31, 2020 by mid-July and will provide details of the confirmed date in due course.
Chief executive, Lyn Rees, said: “I’m delighted to provide more details on the direct impact our dedicated and talented team have made and to share our future ambitions to support the global COVID-19 effort.
“The addition of the Clarigene infectious disease product portfolio strengthens our offering through our commercial channels and supports one of the strategic pillars of growth – our product diversification strategy.
“It’s also especially pleasing to see that the main growth drivers of the business remain on track and with approval for our new Illumina platform NIPT just around the corner I look forward to providing further updates on our exciting new product development pipeline.”