Infectious diseases require fast action if patients are to be treated effectively, contagion contained and lives saved, but current test methods for a number of diseases are slow and insensitive. CEO of HiberGene Diagnostics Brendan Farrell explains how a new range of molecular diagnostic tests using loop-mediated isothermal amplification technology can provide clinicians with highly accurate results within an hour.
How does HiberGene address the unmet clinical needs in human infectious diseases?
Brendan Farrell: There is an unmet need for rapid and accurate tests for certain infectious diseases, such as meningitis. HiberGene’s molecular infectious-disease products do just this, providing highly accurate results within 60 minutes.
With bacterial meningitis, for example, clinicians are currently being asked to make an early diagnosis without having laboratory information available to them. The quickest turnaround in which effective information can be available to a clinician is currently two and a half to three hours. So, at the moment, testing methods are too slow or results are insensitive.
HiberGene is able to solve this by offering a highly accurate test that is also rapid, giving a result less than one hour from the time of taking the sample to returning the results to the clinician.
Why are rapid tests so important, and what difference can HiberGene’s products make?
With certain infectious diseases, it is vital to quickly understand the exact causative agent to ensure appropriate therapy is administered to the patient. HiberGene’s products provide clinicians with the information needed to treat a patient effectively.
Consider our second product – a test for Group B Streptococcus (GBS) – versus current testing methods. When a pregnant woman becomes infected with Group B Streptococcus (GBS) in the birth canal, the infant may pass through the infected canal during birth and become infected, with very serious consequences. Current testing methods include testing the woman at 35-37 weeks of pregnancy, but this is too early: what you really need to know is the status of the woman relative to GBS when she is actually going into labour.
Our second product enables this. Owing to the rapid turnaround of our test results, you can wait until a woman actually goes into labour, take a swab sample and get the results back in about 40 minutes, and if she tests positive, she can be put straight on to IV antibiotics.
What is HiberGene’s vision and mission?
HiberGene strives to become a significant player in the global diagnostics market, through the development, manufacture and marketing of a broad range of high-quality, accurate and rapid tests for infectious diseases. Through the expertise and dedication of its employees, HiberGene will be a provider of quality diagnostic tests to detect serious infectious diseases, leading to timely and appropriate therapeutic intervention for the benefit of patients and healthcare providers alike.
You launched your first product shipment in December 2015. What pipeline is HiberGene looking to develop over the next few years?
Our 2016 launch programme includes tests for GBS, clostridium difficile and norovirus. The programme beyond 2016 will depend on feedback from the market. In Singapore, where we recently attended MEDLAB Asia-Pacific, we’re getting a lot of enquiries about a rapid tuberculosis test – something we’ve had some enquiries about previously, but not to this extent. We are also currently looking at influenza A and B, respiratory syncytial virus and helicobacter pylori as the next products to be launched.
How does the company’s history enable you to support these product launches?
You could describe us as a spin-off from the Royal Victoria Hospital (RVH) in Belfast. RVH had developed a prototype meningitis test and GBS test using loop-mediated isothermal amplification (LAMP) technology. My business partner Peter Kidney and I contacted them, and we felt that the prototypes they had created were very good. We decided to form a business that develops and markets a range of infectious-disease tests using LAMP; we licensed the LAMP technology from Eiken Chemical in Japan, and the meningitis and GBS test prototypes from the Belfast Trust, which oversees RVH.
We also raised funds, mostly from private investment, in order to accelerate product development, and we have licensed the enabling LAMP technology – allowing us to launch four products a year. This effectively short-circuits the development process, meaning the money can be spent on making sure we get those products out and ensuring that our distributors are well trained and motivated.
Globally, where are you present today?
We market and sell our products through independent distributors worldwide, on an exclusive per-territory basis. We currently have distributors in over 20 countries worldwide, to expand to 40 countries by the end of the second quarter. These will be supported by our in-house marketing and sales teams.
