-Rapid Covid-19 test gets UK approval
-Saliva-based Covid-19 test launches across EEA
-UK application submitted
International specialist diagnostics company Novacyt (NCYT:AIM) has become one of the first companies to launch a saliva-based rapid antigen self-test after receiving a CE mark. This means it can be marketed across all 30 EEA countries. (European Economic Area)
The test provides diagnosis of symptomatic and asymptomatic individuals in under 15 minutes.
The test is single-use and designed to be used at hom and is a non-invasive method of collecting samples. The company said the test will be submitted for approval in the UK.
A study undertaken by AstraZeneca (AZN) in 2020 looking at regular testing in the workplace showed adoption by employees improved four-fold when saliva-based testing was used compared with nasal swabs.
Chief executive David Allmond commented: ‘We are delighted to receive this CE mark for our saliva-based lateral flow self-test for Covid-19, one of the first tests for SARS-CoV-2 using this type of easy sample collection and accurate results in as little as 15 minutes.
‘Following UK validation under CTDA legislation of a number of key products in our COVID-19 portfolio over the last six months, we are well placed to continue servicing our customers' COVID-19 testing needs in the UK.’
Investors welcomed the news with shares gaining 6% to 160.6p.
APPROVAL GRANTED
Novacyt also said it has received approval for its Covid-19 Real-Time PCR test to be added to the CTDA (coronavirus test device approvals) list.
The test is designed to be used on the company’s Q16 instrument and is a total workflow solution including sample preparation and analysis. It becomes the company’s third direct-to PCR and fourth product to be added to the CTDA.
The company said ‘as with all the company’s direct-to-PCR products, the test removes the need for complex, manual, or automated extraction solutions to significantly improve laboratory workflow and reduce costs’.
