Genedrives completes manufacturing milestone for Covid-19 test

Near-patient molecular diagnostics company Genedrive has completed the last significant manufacturing milestone in the co-development of the ‘Genedrive 96 SARS-CoV-2’ kit with Cytiva, it announced on Friday.

The AIM-traded firm said the PCR-based test had completed its pilot manufacturing runs, and yielded high performing multiplexed assays for Covid-19 testing.

It said the overall project plan was still on track, adding that it was targeting CE-marking in about three weeks.

The Genedrive 96 SARS-CoV-2 test is one of two assay programmes the firm was developing following its announcement on 25 March, with a Genedrive point-of-care assay due later in the calendar year.

It said the assay combined its PCR chemistry, integrated with Cytiva's ‘LyoStable’ stabilisation technology.

The combination delivered several key competitive advantages to the Genedrive test, compared to the liquid kit-based assays already on market, the board claimed.

It explained that the Genedrive 96 SARS-CoV2-test as a “final format test”, which would only require the addition of a patient sample, with no other user preparation required.

Integrated controls within each test would apparently give confidence to the user that the input sample was of good quality, and that the integrity of each reaction mix was confirmed with another internal standard.

The temperature-stable nature of lyophilisation technology meant that the test can be transported globally, without the need for refrigeration, which would support global product distribution.

“We are very pleased to have passed these technical milestones and with CE-marking planned we will offer our novel high throughput test in the near future,” said chief executive officer David Budd.

“Users will be able to adopt a Covid-19 testing solution with unique assay features.

“The team here at genedrive has been working in close cooperation with the Cytiva team - and both have excelled in the development of a complex assay, while maintaining a firm focus on quality and performance; we remain confident that this assay will make a significant contribution to the testing market.”

At 1615 BST, shares in Genedrive were up 25.87% at 137.2p.