Shares of Manchester-based molecular diagnostics company Genedrive rose about 5% on Monday after the UK Medicines and Healthcare Products Regulatory Agency granted the firm a Coronavirus Test Device Approval (CTDA) enabling the sale of the Genedrive COV19-ID Kit in the United Kingdom.
“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 …” said Genedrive.
“The Genedrive COV19-ID Kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes.
“It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps.
“Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.”
Genedrive CEO David Budd said: “We are very pleased to have received a CTDA, which now allows the UK access to the fastest point-of-care COVID molecular test.
“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.”