HiberGene Diagnostics COVID-19 test launch Medtech Ireland in the news

HiberGene Diagnostics secures CE mark for Covid test

June 18 2020 No Comments

Rapid test a potential game-changer in the fight against the virus

HiberGene Diagnostics chief executive Seamus Gorman has been “bowled over” by the international response to the company’s achievement in attaining European CE mark certification for its new rapid Covid-19 test, he says.

The innovative new test delivers positive results in just 30 minutes, offering a significantly faster option than the majority of currently available alternatives.

CE marking indicates that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area. It is required for products manufactured anywhere in the world that are then marketed in the EU.

HiberGene secured the CE mark for its rapid molecular Covid-19 test following a clinical evaluation study at Dublin’s Mater Private Hospital.

HiberGene already has a strong track record in molecular diagnostics for infectious diseases. Its portable instrument, the HG Swift, can now test for 13 infections including respiratory diseases such as Flu, RSV, and Mycoplasma pneumoniae.

The simplicity of the HG SWIFT instrument allows it to provide hospitals and other clinical settings with a ‘near-patient’ testing solution that could be undertaken at the time of consultation for some diseases, although the primary market remains for laboratory users.

Because results are available almost immediately, without tests being sent off-site to a lab, it allows clinicians to make timely and informed decisions about patient care. With Covid-19, speedy detection is vital in slowing the virus’ spread.

HiberGene Diagnostics’ new test, which is available for sale in Ireland and internationally, uses the company’s proprietary molecular reagent format to accurately detect the virus in nose and throat swabs.

The HG Swift machine can test up to four samples concurrently, with the new Covid-19 assay utilizing an easy to use freeze-dried reagent format.

Positive results are returned within 30 minutes, while negative results are returned within 60 minutes.

Using a low-complexity sample preparation protocol, the test has excellent performance for samples with high to moderate viral loads. When coupled with a nucleic acid extraction method, the system provides sensitivity equivalent to that of the current PCR (Polymerase Chain Reaction) systems for samples from individuals at all stages of Covid-19 infection.

The company is set to undertake further studies and collaborations to evaluate potential additional uses of the test, such as compatibility with new specimen types and patient cohorts.

Clinical evaluations are scheduled at IRCCS Ospedale Policlinico San Martino in Genoa, Italy; Queens University Belfast, Northern Ireland, and at laboratories in China, with HiberGene’s Chinese distribution partner Medcaptain Medical Technologies. The clinical evaluations will evaluate potential additional uses of the test, such as compatibility with new specimen types and patient cohorts,

The development of the new rapid testing solution was backed by a grant of €930,000 from Horizon 2020, the EU’s program for research and innovation.

To date, existing molecular detection methods for Covid-19 typically require sample extraction and batch testing, with samples prepared – and tests run – in bulk, which by its nature reduces turnaround time, explains Seamus Gorman.

In a pandemic situation speed of detection is vital. At the early and highly infectious stage, being able to show positives within 30 minutes is “a game-changer” for the company, he says.

It’s the latest in a series of innovations at HiberGene, which was set up in 2009 and devotes one-third of its full staff complement to research and development. It is this fact which assisted its speedy response to the outbreak of Covid-19. “As a company, we are very flexible and nimble, which enabled us to switch focus to something like this as the need arose,” he says.

It is this innovation and agility, coupled with the EU Horizon 2020 support, which has enabled it to compete in a sector in which its main rivals are major multinational corporations with “much bigger budgets”, he points out.

The company is now set to ramp up rates of production for the new test from 6,000 units per week currently to 45,000 per week by year’s end.  “Our target market is small and medium-sized hospitals globally who don’t typically run PCR as standard and who are looking for an alternative,” explains Gorman.

“Because our machine is small, and can run off a battery as well as mains supply, it is an offering that can allow molecular testing in even underdeveloped and disadvantaged areas,” he points out.

Once risk management of potential Covid-19 samples is in place, training on the HiberGene system takes just “a couple of hours and requires basic pipette skills,” says Gorman.

Interest in the new test is particularly strong from Eastern Europe and Africa, regions in which it already has strong distribution partners.

As well as testing for respiratory diseases, HiberGene is also well established in the EU, Middle East, and Asia as a provider of test solutions for sexually transmitted infections and women’s health.  It is now starting to export to the Americas.

For Gorman, the fact that HiberGene’s new CE marked test looks set to become an invaluable tool with which to turn the tide against Covid-19 is a matter of pride. “We feel privileged to be part of the solution,” he says.

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