Biotech group achieves accreditation for its COVID-19 test kit

Lyn Rees

Yourgene, the Manchester-based molecular diagnostics group, has achieved CE-IVD marking for its coronavirus test kit.

The CE-IVD version of the Clarigene SARS-CoV-2 test will be used in Yourgene’s high throughput COVID-19 service lab in Manchester and will allow the business to provide corporate partners and healthcare settings, such as care homes and private GP practices, with a fast and reliable COVID-19 lab testing service.

The kit is a RT-qPCR (real-time quantitative polymerase chain reaction) assay which detects the presence of SARS CoV-2 viral RNA.

RNA (Ribonucleic acid) is needed to detect the COVID-19 virus.

The test uses two viral RNA targets, nucleocapsid gene (N) and envelope gene (E), which are SARS-CoV-2 specific and this prevents any cross reactivity with other coronaviruses.

The use of dual viral targets and assay controls provides a more reliable result, while also making it more desirable across several European regions which require the dual viral targets for reimbursement.

Clinical validation of the test has shown around 99.9% accuracy with no false positive or false negative results.

Additional studies have shown 100% repeatability data and an average 99.7% reproducibility, approximately.

The test only detects SARS CoV-2 RNA and shows no cross reactivity with other respiratory viruses.

Inadequate sample collection has been a significant issue in the global pandemic and the Clarigene test kit has an internal control that detects poor-quality samples to give an invalid result, allowing greater confidence in negative results.

The test kit will be available throughout Europe and will be rolled out through Yourgene’s direct sales teams and distribution network, and additional submissions are in progress for other regulatory jurisdictions.

Chief executive, Lyn Rees, said: “I would like to congratulate the Yourgene team for their hard work in achieving the CE-IVD mark for the Clarigene SARS-CoV-2 Test in such a short amount of time.

“There is a significant opportunity to drive sales of the Clarigene SARS-CoV-2 kits, however, we understand that the COVID-19 testing market is dynamic and with this in mind, we will commit to updating shareholders on a quarterly basis on the commercial take-up of this product.”

US broker Stifel reiterated its ‘buy’ call on Yourgene’s stock after today’s announcement.

It said: “We regard this as further testament, which is yet again on time, to Yourgene’s diagnostics capabilities.

“At this stage we have not made any changes to our forecasts to reflect the upside potential that could come from an effective COVID-19 testing service and commercially available assay.

“With the pandemic continuing to roll on around the globe, we believe the demand for COVID-19 tests, particularly those with greater accuracy which Clarigene is demonstrating, will remain for some time.

“We expect Yourgene to update the market in September with its commercial progress and traction with this COVID-19 test. Reiterate Buy.”