The Wetherby-based group saw its shares plunge following Twitter speculation that the MHRA had rejected its application on May 20.
In an update to the market, Avacta said: “To date, neither Avacta nor Mologic have received any update from the MHRA. Avacta will update the market when it is in a position to do so.”
Mologic is Avacta’s partner in the lateral flow test.
On May 10, Avacta said it was expecting imminent approval and its test should be available on the market “in the coming days”. Avacta has previously said it believes the test will be the most sensitive spike antigen lateral flow test to date.
Shareholders dumped Avacta stock after retail investors took to Twitter claiming that Avacta’s Covid-19 test was rejected because of an administrative error which meant the application had to be resubmitted. Avacta dismissed the rumours, saying that it has had no response or update from the MHRA.
The firm has been in talks with the Department of Health to roll out its test in the UK and it is also in active discussion with distributors in 25 EU markets.
Avacta said on May 10 that a Declaration of Conformity for CE mark of its AffiDX SARS-CoV-2 antigen rapid test for professional use had been submitted to the MHRA.
Dr Alastair Smith, chief executive of Avacta, said that as soon as the CE Mark is registered, the test can immediately be placed on the market and Avacta will be able to sell the devices in markets where the CE Mark is accepted.
“The CE Mark we have submitted the application for is for professional use,” he added.
“This means that the test can be sold to governments, healthcare agencies, hospitals, companies, organisations etc where a trained professional such as a doctor, nurse, occupational therapist or other form of trained / nominated specialist performs the test.”
Avacta has developed a lateral flow test using its Affimer platform to detect the coronavirus spike antigen. Affimers are Avacta’s high-tech alternative to antibodies.
A clinical study of the test on 98 positive Covid-19 samples demonstrated “excellent” performance in identifying the SARS-CoV-2 virus.