Rapid Covid-19 test by Irish group HiberGene gets EU approval

Irish company HiberGene Diagnostics has secured European approval for a highly accurate, low-cost, rapid test for coronavirus. The test promises to deliver results for patients who have the Covid-19 virus within 30 minutes.

The Dublin company’s test avoids the need to send samples to big, specialised laboratories but still delivers results that are 96 per cent to 97.5 per cent accurate, in line with those produced by the most sophisticated lab tests.

The test, which was validated in the Mater Private hospital, has now secured a CE mark that authorises its sale across the European Union.

The company will ship its first orders for the test this week. Russia, which is currently struggling to cope with the Covid-19 crisis, is among the first in line to receive the tests. It was one of a number of countries that had pre-ordered the test, pending CE approval.

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The test works by mixing patient swab samples with a solution that is heated for five minutes, says chief technology officer Gary Keating. A freeze-dried reagent is then applied and the sample put through the company’s portable diagnostic instrument, the HG Swift, which delivers confirmation of positive tests in 10 minutes.

The low-complexity approach allows it to keep costs for the tests down as well as delivering rapid results. If a patient is negative for the virus – ie they don’t have Covid-19 – the result will be available within an hour.

And, by not having to strip DNA from the samples in order to test, HiberGene avoids having to source specialised reagents for that process. Scarce supply of these reagents was a major cause of delays in testing in Ireland and elsewhere earlier in the pandemic, which has now killed 1,561 patients in Ireland. A further 24,251 have fallen ill with the virus.

Footprint

HiberGene says it will focus on markets in Europe, the Middle East and Asia where it already has a footprint, including in China where it has a local distribution partner, Medcaptain.

The company, which manufactures its own products, will initially produce 6,000 of the rapid Covid test kits a week.

"We will remain at our current scale [of manufacturing] until we see what the market warrants," said Seamus Gorman, who took over as chief executive of the business last month.

He said HiberGene had plans in place to step up manufacturing, as required, to 10,000, 22,000 or even 45,000 tests a week, although he admitted it would take until close to the end of the year to put the resources in place for that maximum production capacity.

The company is also examining the prospect of entering the competitive US market. The FDA has been granting emergency approvals for Covid tests and therapies as the country battles the pandemic, but it would require HiberGene to partner with a company that already has a physical presence in the US market.

HiberGene was initially approached by its Chinese partner about the possibility of developing a test when the virus first flared in Wuhan province. At the time, there seemed little prospect of it becoming a global pandemic.

“For a company that hasn’t a huge amount of cash, it’s not something you want to bank everything on without having some backing,” Mr Gorman said at the time. An EU decision to fund coronavirus research as the contagion spread was critical. HiberGene applied and secured €930,000 for its rapid test project. “Having the backing of the EU money is massive,” said Mr Gorman.

Game-changer

He admitted that success in developing the test was a game-changer for the company, which was in the process of closing a €3.4 million funding round at the same time.

“Investors were willing to back the project because they knew we were making inroads,” he said. “The Covid-19 pandemic is the greatest challenge to humanity in our lifetimes.”

The test developed by HiberGene works best for patients with moderate or high viral load – those who have been displaying symptoms for some days.

The company is working with partners in Queen's University Belfast, Genoa in Italy and China to examine its efficacy in other patient groups – particularly those who are not yet showing any symptoms associated with the virus.

This asymptomatic group is considered a significant issue for governments looking to reopen economies without risking a second or subsequent surge of infection.

HiberGene Diagnostics, which was founded in 2009, brought its first product – a test for meningitis – to market in 2015. It has since developed and sells 13 molecular tests to identify critical infectious diseases, sexually transmitted infections and hospital-acquired infections.