Authors: Tim Cummins, CEO/co-founder, AltraTech and Brian O’Farrell PhD, CSO/co-founder, AltraTech ‘Necessity is the mother of invention,’ it is said. This is an apt phrase to describe the formation of AltraTech Ltd in 2013, which was the year of the horsemeat adulteration scandal. We had been mulling on biosensors, given our complementary backgrounds in semiconductors and genetics. Suddenly, here was a pressing market need, a problem to be solved. Food DNA-testing, to 0.1% detection limits, was on prime-time news. Large supermarket chains were suffering painful reputational damage and sales declines, as they scrambled to recall and quarantine burger batches, while waiting a week or longer for DNA test results. Consumer awareness of the need for more accurate and foolproof DNA testing (to 0.1% limits) rose significantly as a result of the horse-DNA incident, new regulations and other food fraud crises. Agriculture Minister Simon Coveney praised food suppliers who had begun a regular DNA-testing regime “above and beyond the legal requirements”. While a simplex horse-DNA test is interesting and useful, a simultaneous multiplex test of five or six food DNA markers emerged as a strong customer requirement from our prototype demonstrations and customer visits. So we have written a first product definition with eight sensor detectors, functionalised with beef, lamb, pork, poultry, horse and goat markers, as well as positive and negative control sensors. This addresses worldwide food sensibilities, food fraud and cultural and religious concerns such as Halal food authenticity. There are similar consumer pressures for correct labeling of genetically-modified (GM) foodstuffs, accurate labeling of fish species, detection of harmful algal blooms (which can lead to diarrhetic shellfish poisoning) and several interesting applications in the agriculture sector. These further emphasise the pressing need for a programmable, cost-effective and rapid DNA diagnostic technology platform. So for example, by functionalising five of the sensors with DNA markers 35S, NOS, FMV, BAR and CTP2:CTP4 EPSPS, the detector chip can identifythe  presence or absence of genetically-modified organisms (GMOs). BeadCAP will also work with viruses, basically anything with DNA or RNA content. BVD (bovine viral diarrhoea) virus in newborn calves is an area we will also trial. This will enable a farmer or vet to instantly cull a persistently infected (PI) calf and prevent infection spreading in the herd. Animal health overlaps directly with our overall agri-food business strategy. This programmable nature of the technology, using off-the-shelf standard library DNA probes, points to many other future market opportunities, including pathogen testing for food safety and bio-medical diagnostics. DEVELOPMENT OF ASSAY The assay is currently being developed in the laboratory with test tubes, magnetic beads, dual-specific primer reagents and a silicon chip ultra-sensitive capacitive detector. No expensive optical or PCR (polymerase chain reaction) equipment is needed and there is no DNA amplification. This is particularly important for any on-site DNA test kit. It reduces the risk of cross-contamination and simplifies quantification, due to much simpler chemistry. The detector uses standard digital CMOS semiconductor chips, which circumvents issues associated with gold or platinum chips such as manufacturing difficulties or lack of availability in production foundries. This is the Achilles heel of many other attempts at electrochemical detection of DNA over the years. Capacitance sensing with standard digital CMOS chips is much simpler, and more amenable to high accuracy and high volume/low cost production. The end user – anyone from big food processors and retail outlets to consumers or research and development laboratories – puts a meat-tissue sample (raw or cooked) in the first tube and follows assay steps. The assay takes approximately 30 minutes from blood or simple samples, and 40 to 60 minutes for more complex food-matrix samples. The kit is will run from a 12V outlet or a laptop USB, so results are immediately available on screen and uploaded to a central data base. Future smartphone and wireless versions are on the roadmap. Intellectual property is a hot topic in the diagnostics market. We address this in three ways:

• Patent-disclosures: we have filed three core patents on the BeadCAP technology. PCT searches indicate significant novelty;
• Off-patents: many of the key techniques we employ are now off patent, such as magnetic-beads for DNA target extraction, capacitive bio sensing;
•  Know-how/trade-secret: techniques such as choice of buffers and reagents may be unpatentable in their own right, but important in the overall assay. These we keep as proprietary trade secret.

With a business plan articulating an attractive market opportunity, a technology and products to address this and a strong IP base, we recently secured €900,000 seed-funding. This comprises a €650,000 investment by Kernel Capital, with the remaining funds provided by Enterprise Ireland and founders. With these funds, the kit will be further developed and tested over the next 12 months, in field-trials on customer sites. This is an interesting and exciting challenge, requiring innovation across multiple disciplines, getting engineers and scientists speaking the same language and assembling a start-up team of experienced innovators from diverse disciplines in life-sciences and semiconductors. FIELD TRIALS Some field trials have already begun and we are keen to liase with early-adopter partner customers. The objective being to perform a double-blind DNA food identification test on a customer premises, using just test tubes, pipettes, a heater block and our semiconductor capacitive detectors. We will then face a choice...should we commercialise the technology initially for retail outlets and end users as a hand-held microfluidic single-use disposable cartridge, or as a 96-well automated high throughput version for food-processors to use on-site? We will eventually do both, but will be heavily influenced by customer feedback and future A-round investors. These plans are ambitious, however this is a huge worldwide market opportunity. And the good news over the past few years is that scale-up funds now exist for small- and medium-sized enterprises (SMEs) to grow and build their companies – both here in Ireland with Government/National Pensions Reserve Fund and Enterprise-Ireland-led scale-up funds with international equity partners, and across Europe under the new Horizon 2020 and European Investment Bank/European Investment Fund schemes. There is a realisation that innovative SMEs are key to driving new technologies and opportunities. It has never been a better time for entrepreneurs with a vision, and we certainly want to give a shot at scaling up AltraTech and BeadCAP into a major European technology company, serving worldwide markets. For more info, see www.altratech.com. [caption id="attachment_16116" align="alignright" width="814"] Brian O'Farrell (left) and Tim Cummins[/caption] Tim Cummins is CEO and co-founder of AltraTech. He has 25 years’ experience in semiconductors and sensors in design, business development and senior management. Most recently, he was managing director of Silicon Laboratories Irl Ltd, following the acquisition of his start-up company ChipSensors. AltraTech is his third start-up company in the past decade. He is a senior member of the Institute of Electrical and Electronics Engineers (IEEE), has five IEEE publications and holds 17 US patents. Brian O’Farrell PhD is CSO and co-founder of AltraTech.He has 15 years’ experience in molecular biology and population genetics. His specialties range from evolutionary biology and rare DNA sample preparation to lab-on-chip development. He is proficient in structured query language and python scripting and he designed, built and commissioned a robotic automated DNA extraction pipeline and analysis system for food pathogen genotyping at the Environmental Research Institute in University College Cork. He has authored six publications on genetics and co-founded AltraTech in 2013.