Biosensia screening test set to speed up diagnosis of head trauma

A new screening test from the Irish biotech start-up Biosensia could play a significant role in the speedy diagnosis of head trauma.

Proteomics is the study of the structures and functions of proteins, and it’s currently a very hot topic in the world of molecular biology. In a nutshell, it helps scientists understand the functions of cellular systems in human disease. Researchers at Biosensia are currently using proteomics to look at how body proteins change due to an illness or to a major event such as a traumatic brain injury (TBI).

Human cells respond to change by regulating protein activity, and researchers around the world are trying to isolate the protein signatures for different conditions. Biosensia’s focus is on the signature for neurodegenerative disorders, including TBIs, and it is combining this knowledge with its proprietary diagnostics technology to test for the presence and severity of such an injury.

Biosensia’s point-of-care diagnostic platform is called RapiPlex and is due to come on the market in about 24 months’ time. What makes it different from anything else available at the moment is how fast it delivers results and the fact that it can “multiplex”, or test for multiple diseases/problems, from a single sample.

"Our system is a fluorescent immunoassay-based optical detection platform capable of providing up to 24 results from a single biological sample in between five and 20 minutes," says chief operating officer NiamhO'Luanaigh, a biochemist by training who had a 10-year career in diagnostic testing in the UK and the US before joining Biosensia in 2011. O'Luanaigh's experience includes environmental testing for bio-warfare detection.

Biosensia's origins go back to 2008, when it was founded by Prof Gareth Redmond, now head of chemistry at University College Dublin, and Prof Gabriel Crean, now chief executive officer at Luxembourg Institute of Science and Technology. The company is based at the innovation hub NovaUCD.

Initially, the platform development was outsourced to the US, but in 2011 a decision was made to bring it back in-house. O’Luanaigh was hired to help make this happen and the platform is now in the final stages of development.

Funding to date has amounted to about €10 million and has come from a number of venture capital sources, including Atlantic Bridge, Seroba Lifesciences, Street Capital and Act Venture Capital, as well as private investors who have backed the company since its formation. Biosensia also received funding under the EU's Horizon 2020 programme, which supported its work on a project relating to TB. The company expects to be revenue-earning by 2018.

“The multiplexing and high-sensitivity capabilities of our system are right on trend with recent developments in clinical proteomic diagnostics, and within the last six months we have signed two development agreements with external partners that will start generating revenues and help grow the business significantly over the next 18-24 months,” says O’Luanaigh. “We intend to follow a co-development licensing strategy to minimise the time, costs and risk associated with bringing our product to market, and are actively pursuing industry collaborations.

“Discussions are ongoing in areas including sepsis and infectious disease panels, and we very much see our two recent contracts as external validation by market leaders of the capabilities of our platform. Needless to say, we are pretty pleased with that. For these particular contracts, we have developed products for TB triage and for the monitoring of systemic Lupus. Lupus never goes away, so it is important that practitioners are aware of the levels of active inflammation and respond with the appropriate treatment.”

Biosensia has some competition in the marketplace, although this is coming primarily from other start-ups, not from the bigger players. “There’s one large company in the space, but its system can only manage four results, compared with our 24,” O’Luanaigh says. “We’re more developed than anyone else, not least because we can multitest using neat samples. There is no need for the sample to go to a lab first. In addition, we’ve put a huge amount of time into the development of the unit, which is low-cost, doesn’t need much space, is easy to use, and doesn’t have loads of wires trailing out the back. In reality, we are probably of most interest to any of the bigger companies as a potential acquisition.”

The RapiPlex diagnostic unit is controlled by a touchscreen with icons rather than text, as most people are familiar with graphics from their mobile phones and graphics also cross language barriers. The unit can be plugged into the mains, powered by rechargeable batteries or wifi, and eventually it will have GSM connectivity. Biosensia has invested heavily in the protection of its IP across all areas of its technology, from the unit’s disposable cartridges to the fluorescent platform. The integration of the individual elements is also protected.

“RapiPlex can be used in a range of settings, from acute care in hospitals to GPs’ surgeries to mobile or field clinics in developing countries,” O’Luanaigh says. “It can also be used by suitably trained lay people for the management of long-term health conditions. However, one of the biggest potential markets for the unit is in-vitro diagnostics for human health, while we also have plans to roll out the system for veterinary, food safety – for example, testing for residues in milk – and environmental testing.”