Genedrive PLC said it was granted a coronavirus test device approval (CTDA) by the UK Medicines and Healthcare Products Regulatory Agency, enabling the sale of its COV19-ID Kit in the UK.
The company’s kit is a rapid molecular diagnostic test that delivers positive results as quickly as seven-and-a-half minutes and negative results within 17 minutes, it said in a statement.
Since submission for approval, the product has undergone positive external validation, commercial partners have been engaged in specific countries and product claims have been expanded to include the testing of asymptomatic patients.
“The performance of the test has met CTDA standards in all regards, which positions Genedrive well to engage in opportunities as they develop going forwards in the UK," David Budd, chief executive, said.
Its application for approval was made on 21 December.
The company’s shares leapt 6.7%, or 1.6p, to 24.8p on Monday morning.