In a pandemic, time is of the essence. A new diagnostic cuts 25% off testing times.
Serosep, a leading manufacturer of laboratory diagnostic products, has developed a new weapon to help in the global fight against Covid-19.
The Limerick, Ireland headquartered company is set to launch a molecular diagnostic testing product which reduces the time it currently takes to identify the presence of the virus from four hours to less than 3 hours.
The product, RespiBio, detects Covid-19 from nasopharyngeal and throat swabs. Aimed at medium to high-throughput clinical laboratories, it uses novel, efficient, molecular diagnostics techniques.
What makes RespiBio unique is that, unlike competitor products, it does away with the need for traditional RNA (ribonucleic acid) extraction practices.
“Many competitor products require RNA extraction prior to testing. This step alone can add one and a half to two hours to many of the current test systems on the market,” says Serosep founder and chief executive Dermot Scanlon.
Currently it takes several hours to process a molecular based test, with the RNA extraction step alone adding anything from 1.5 to 2 hours.
“The benefit of our test product is that we do not have an RNA extraction step. Our method of RNA extraction is already built into the RespiBio test”, he explains.
The new diagnostic is based on the success of an existing diagnostic created by Serosep, called EntericBio.
“We launched our new innovative molecular diagnostic test, EntericBio, in the end of 2012,” he explains. “This test detects multi pathogenic bacteria, viruses and parasites from patients suffering gastroenteritis. It also detects gastrointestinal multidrug-resistant bacteria.”
EntericBio was the first commercial product in the world to detect faecal pathogens within three hours and quickly became a market leader in a number of countries.
“Currently in eight out of every 10 samples tested for gastroenteritis in Ireland, Northern Ireland and Wales, EntericBio is the test method of choice used by laboratories,” he says.
In the UK four out of every 10 samples use EntericBio. The product is used in Belgium, Scandinavia, Israel, Kuwait, New Zealand and South Africa. In June 2019 EntericBio received US FDA (Food and Drugs Administration) approval for sale there.
Its success is attributable to the fact that the test is “designed by microbiologists, for microbiologists,” he says. “Our target market consists of high throughput laboratories which want to get results within a few hours.”
The success of EntericBio led to an expansion if Serosep’s workforce, which currently consists of 70 people in Limerick and a further 10 in the UK. The company, which was established in 1997, invests heavily in in-house research, development and innovation.
“We are somewhat unique in that we research and develop, design, manufacture and market our own products, and we partner with other companies for hardware and software solutions,” he explains.
The strength of its in-house capabilities enabled it to adapt the technology behind EntericBio to develop RespiBio, which now has the capacity to be a major weapon in the global arsenal against the spread of Covid-19.
“Already thousands of tests of our flagship product EntericBio take place daily, with several million conducted around the world to date. RespiBio is based on the same platform technology and offers the exact same uniqueness as EntericBio in relation to RNA extraction – that is, it does away with the traditionally cumbersome first step. In a pandemic situation, what we need is to speed up tests,” he says.
The innovation is not to be confused with the vaunted “rapid testing kits” we hear so much about in the media.
Rather, “RespiBio is a gold standard test that adheres to very stringent guidelines. It has been developed to provide really high sensitivity testing for use in hospital laboratories and big screening laboratories,” he explains.
As well as being highly effective, RespiBio is easy to use. “We already have this technology out in the field, thanks to EntericBio, so clinical laboratories and hospitals already have the equipment and are already trained how to use it. Using it for RespiBio is as simple as flicking on a switch.”
The team at Serosep is currently working around the clock to play its part in the fight against Covid-19. RespiBio is set to undergo clinical trials and, he predicts, will be available from mid-April 2020.
“We have always said we would never let our customers down,” says Scanlon. “The company’s policy of building significant stock of it’s flagship product EntericBio has always been expensive to do but it is paying off now because we are in a position to switch production to RespiBio with no affect in supply to our existing users”