Regulatory delays hamper diagnostics firm Genedrive

David Budd

Genedrive, the Manchester-based molecular testing business, saw revenues fall in the six months to December 31, 2020, but pre-tax losses also declined.

The business said it has been hampered by regulatory delays for its COVID-19 testing kit.

Revenues of £355,000 compared with £627,000 in 2019, although a pre-tax loss of £621,000 was an improvement on the previous year’s £3.332m loss.

The R&D spend of £2.3m was the same as in 2019, and by December 31, 2020, it had cash of £3.8m, against £8.2m at June 30, 2020. As of March 15, 2021, the company had cash of £2.8m, with an R&D tax credit of £1m still owing.

Genedrive said regulatory approvals for its 96 SARS-CoV-2 kit are still outstanding with the World Health Organisation and America’s Food and Drug Administration, and timings are uncertain.

It said this is the strongest headwind on its ability to acquire customers: “We continue to experience delays in gaining the key regulatory approvals from the FDA, WHO and in India. In May 2020, approvals were occurring rapidly, but the urgency of regulatory bodies in granting new approvals has subsided.

“There are no confirmed timelines for these processes and, despite lodging our file claims over summer 2020, we are unable to affect the speed with which our submissions might get reviewed.”

It revealed: “In India our application has been repeatedly frustrated by test requirements that are neither documented nor communicated to applicants. Although our application remains ongoing but we are reducing our attention on the market as there appears no certainty of a positive outcome against unknown requirements.”

The company has obtained regulatory approval in Europe, in South Africa and Thailand.

Chief executive, David Budd, said: “During 2020 the company’s development focus moved to the global COVID PCR testing opportunity.

“While commercial progress has been slowed by registration requirements, the company made great strides in the development of our COVID test portfolio, POC (point of care) test platform development, scalable manufacturing capability, and a commercial distribution arrangement with Beckman Coulter that has the potential to be significant and long-term.

“Much of our focus has shifted away from low and middle income markets to more western markets with DoD (pathogen detection), AIHL (anti-biotic induced hearing), and COVID, driven by the market dynamics and restrictions of travel.”

He added: “These markets, however, work under standard commercial terms and cycles, and offer more predictable, and often higher margin commercial opportunities, and we anticipate this focus will remain for the foreseeable future.”

And he said: “While cognisant of the need for cash generative revenues the board is confident in the strategy to focus on larger commercial opportunities in the COVID-19 space and expect progression from this strategy in the coming months, alongside progress with the commercialisation of AIHL, DoD and HCV products.”

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