I became CEO of EKF Diagnostics in 2009. At that time the business was known as IBL plc. Before taking on the role at EKF, I was CEO of British Biocell International (BBI), based in Cardiff in South Wales.
Outside of work rugby has always been my passion, first as a player and now as a spectator. It’s especially enjoyable these days, as Wales is a strong international team. I keep myself fit by circuit training and walking our dog in the countryside near where we live.
EKF Diagnostics is a global IVD business. Although we’re a relatively small business in this industry, EKF is hard to pigeonhole as it has so many different aspects. Three years ago EKF was a specialist manufacturer of a small range of blood analyzers with niches in diabetes, sports medicine, and blood banking. Today, however, EKF has a product portfolio that includes a growing range of diagnostic devices, clinical chemistry assays, rapid tests, kidney biomarkers, and enzyme production, and most recently, we’ve branched into molecular diagnostics.
Continual growth and expansion provide new services for customers. We are a cross-over IVD business. By that I mean that we have interests in several IVD sectors including point-of-care, central laboratory and, through the establishment of our molecular diagnostic division, companion diagnostics.
Products offered by EKF and benefits they provide. I’d like to think we’re unique in many ways, not the least being the diversity of our portfolio, but I’d like to focus on three products that we’ve launched in the last 12 months. First, there is Quo-Lab, which is a portable HbA1c analyzer. Quo-Lab is one of the smallest, most affordable HbA1c analyzers on the market. This means that getting lab-quality results is now achievable in developing countries around the world–although we’ve had plenty of interest from elsewhere too. It has a unique sampling technique that reduces the need for operator training, which means that users can be introduced to the device and operate it in a matter of hours.
Second, β-Hydroxybutyrate Liquid reagent, or BHB. We’ve been manufacturing and selling BHB for a decade as a test for measuring the buildup of ketones in blood. Last year we saw an explosion in demand, partly due to our educational program on the merits of using BHB as an early warning test for ketoacidosis. Due to the success of the liquid reagent, we’ve just introduced a handheld analyzer that uses low-cost test strips and serum or plasma–the STAT-Site M BHB. This product takes BHB testing one step closer to becoming a true POC parameter.
Finally, our molecular diagnostics division is based on a unique technology called PointMan™. PointMan is highly sensitive and selective, with the ability to enrich and detect rare mutations from a small amount of sample material. PointMan will be a useful tool for companion diagnostics, particularly oncology where the availability of the tumour biopsy is limited. We are currently investigating the capability of PointMan kits to enrich mutant DNA from a blood-based sample without the need for further biopsy. This could have the capability to change the way we screen for cancer.
Features that differentiate EKF’s HbA1c, hemoglobin, and glucose analyzers. All our analyzers are based on one guiding principle: ease of use. Any nurse, GP, or laboratorian can learn the basics in a matter of minutes. We believe that this, together with affordable pricing, is democratizing IVD by giving patients and practitioners access to lab-quality data for basic healthcare tests.
Impact of the 2011 Stanbio acquisition on EKF customers. Acquiring Stanbio was a logical step for EKF as it was already one of our largest distributors of Hemo Control, our hemoglobin analyzer (sold as HemoPoint H2 in North America). We needed a U.S. base to service an OEM contract with Alere for HemoPoint, and acquiring Stanbio means that EKF can provide Alere with the local backup it needs.
Stanbio also provided us with access to Central and South American markets where EKF, as a European business, had sometimes struggled. The first evidence of the success of this strategy came at the end of 2011 when Stanbio tendered for and won contracts with the Mexican Institute of Social Security (IMSS).
Our distribution network has also benefitted in a number of ways. EKF distributors now have access to Stanbio’s unique product portfolio, including clinical chemistry, pregnancy, and infectious disease rapid tests, as well as complementary POC analyzers, such as the STAT-Site M Hemoglobin and BHB analyzers. Also, we gained a channel through which we can accelerate the launch of EKF products into the U.S. and Latin American markets. We’re currently going through the regulatory process for Quo-Test and Quo-Lab, our HbA1c devices.
Exciting projects are in development. We’re currently involved in a number of clinical trials looking into the use of lactate in obstetrics using our Lactate Scout+ device. Lactate Scout+ was developed for sports performance management, but recent innovations in hospitals in Europe have identified uses for lactate in determining stress in unborn children during delivery and also postnatal depression.
The work we’re doing at EKF Molecular Diagnostics is something I’m really excited about. The PointMan products currently comprise three kits for enriching mutations in BRAF, KRAS, and EGFR T790M genes associated with melanoma and colorectal and lung cancers. We’ve had a great response so far and we’re working on additional kits for release later in the autumn.
I’ve never hidden the fact that the EKF business model has always been “buy and build.” We’ve acquired a number of businesses in less than three years, and we are always on the lookout for other IVD companies that can drive our business into new areas. We’re open to any ideas that can take us forward as a business and build the EKF Diagnostics brand.