ELITechGroup Biomedical Systems is celebrating its 50th anniversary this year. CLI caught up with Bryce McEuen (Managing Director and Business Unit Manager, Biomedical Systems) to discover more about the company’s story over the last 50 years.

Congratulations on the 50th anniversary of ELITechGroup Biomedical Systems. What happened in 1970 to bring the business into existence?

The founder, Wayne Barlow, of Wescor, Inc. at the time was working for a number of universities in Utah, USA, and he and a number of his colleagues were bidding on government contract work to highly complex problems in the aerospace and agricultural industries. They were solution providers with a really strong engineering and R&D capability and various opportunities came along for them to innovate and develop products that offered really excellent solutions. So they were primarily doing individual jobs that were unique and complicated and they were very successful but they didn’t have a re-occurring kind of business model. However, one of the products that they had developed, actually an agricultural product (the HR-33T and the C-52 sample chamber), was being used by a researcher in a hospital in a medical application and he provided feedback about how the company could refine its design to include some additional functions and features that made it very suitable for diagnosing various ailments from liquid samples. That was about 1972, and enabled a significant strategic shift in focus and launched the company into one that designed and manufactured diagnostic products for continuous supply into the in vitro diagnostics (IVD) market segment and we’ve been in that market segment ever since.

What does the company specialize in now?

We focus on providing products that offer solutions in the marketplace, whether that’s a new diagnostic methodology, developing a lower cost solution or whether that’s a workflow solution, that enables the technicians in a laboratory to perform their work more easily and to provide a result.

What have been the cornerstones of the group’s success?

At the very beginning, the aim of the founder was to develop solutions in the form of products – software and hardware – that offered unique solutions to very complicated problems. From the beginning the company developed a culture of solving problems with products of really excellent quality and that’s been a hallmark of the company ever since – we develop and offer to our customers around the world high-quality products.
One of the second hallmarks of our business is that we really pride ourselves on excellent customer support. We really want to ensure that our customers are happy with the products they receive, that the products meet their needs and they know that we are always here to support them with any questions they have. This support is given in a number of ways.
First, we really strive to provide outstanding applications support where we provide direct training, as well as support over the phone and via email, to users who have our and use our products, and are really trying to understand how they can apply the product in their workflow to improve their work.
Second, we provide outstanding service support, if there is an occasion where an instrument does require service or maintenance.
Third, we provide outstanding supply chain support, our lead-time performance and delivery performance to our users is world class.

Bryce, when did you arrive in the company, what was your pathway to becoming the current managing director of the Biomedical Systems Unit, and what does your previous experience mean you can bring to the business?

My background is in mechanical engineering. I started with the company as an engineer, and worked to help the company during the early days to identify ways to streamline product design, to improve the design for manufacturability, to improve all manufacturing processes. We really worked to strengthen our quality management systems, all things to improve the quality of the products and the services that we delivered. During the course of time, the original company was acquired by the ELITechGroup, we became integrated within the ELITechGroup there were opportunities to participate in a number of due-diligence activities and, when we acquired a few other companies, I had the opportunity to work on operational integration activities. Then I began to work more directly with selling teams to identify ways to improve sales outcomes. As the company has evolved and changed, and individuals have retired, I found myself in a unique position, where I understood well all facets of the business: from engineering to operations, manufacturing, to quality, regulatory affairs, marketing and sales, and really I’m well equipped today to speak with and meet all of those functions within the business unit to achieve future successes and to drive the growth of the business unit within the ELITechGroup.

What are some of the current challenges that the business is facing and what do you envisage for its future?

That’s a great question. We’ve deployed a pretty rigorous strategic planning process that we use to constantly evaluate the entire business, and as part of that we do an in-depth environmental scan to better understand those external factors that impact our business, and I’ll highlight just a few.
First, the technological changes that are taking place today especially in diagnostics are huge, with the integration of electronic medical records, and this extends all the way into the lab with full traceability. We are moving away from manual, time-consuming, tedious diagnostic processes to workflows that are highly automated and efficient and effective. So on a technological front we see huge advancements that are taking place across the industry that are evolving at a pretty rapid pace.
Second, the demographics and needs of the patient population and the workforce are changing. The older generations were not accustomed to dealing with digital workflows and the younger generation has grown up with mobile phones, for example, in their hands and are accustomed to state-of-the-art technologies and this again is driving the move towards digital, highly automated workflows in labs.
Third, is to identify where we can differentiate our company, our products and our services in a highly complex market; continue to maintain and comply with a rapidly changing regulatory environment and to deliver products at an affordable price that enable healthcare providers to provide reliable diagnosis and corresponding treatment to their patients who are ill.
For the future, we continue to see a number of things changing rapidly, and our ability to respond to those changes and to continue to innovate and provide labs with superior products and solutions that comply and deliver excellent results remains one of the biggest goals. In the diagnostics industry today, there is tremendous opportunity to continue to innovate and look for ways to make life in the lab easier, while still providing reliable diagnostic outcomes.

In terms of IVD, what are the products that you feel have particular impact?

There are a number of products within our product portfolio that I absolutely love, some due to their straight simplicity and others due to their overall outstanding impact on the market. This is really one of the things that motivates me as an individual and I would say drives the work that I do. I’ll illustrate two.
The first product is one that really has a meaningful impact. We manufacture a number of devices that are used to diagnose cystic fibrosis (CF), primarily in infants. CF is a genetic disease, there is no known cure, and the mean life of a patient with CF is approximately 40 years. It is a horrible condition that requires constant care and treatment and is really difficult to manage. We have nearly 40 years of experience in the field of CF diagnostics and the products that are provided by the ELITechGroup today really enable doctors to accurately diagnose CF and then provide care and treatment. Without care and treatment the mean expected life of a patient with CF might be 8–10 years and I’ve met with clinicians and physicians around the world who are using our products and they see a very meaningful impact on the lives of people who are being diagnosed with this terrible disease, allowing them to obtain appropriate treatment and have an extended and improved quality of life. It is really important for me, because we’re providing something that works really well and that can help people.
One of the other products that we manufacture, the Aerospray® product portfolio, are again fairly simple but definitely core products. This family of instruments stain a variety of different sample types on microscope slides. Sample types include blood smears, fine needle aspirates, swabs, buccal smears, urines, etc, for extremely detailed diagnostic work. A sample is taken from the patient and stained and the product portfolio is used in all the core segments of the IVD space – hematology, microbiology, infectious disease, cytology – and allows the identification of cancers, bacterial infections, different infectious diseases and all kinds of cellular abnormalities, which helps to determine the best treatment for the patient.
Those products are workhorse products. They work really well, they process millions of samples per year and are widely used around the world today. For me, I would say the Aerospray® portfolio and the CF sweat testing systems portfolio carry a special place, because of their use and the impact they have on treating patients.

Congratulations again and thank you for your time

Thank you. It has been wonderful to work with the ELITechGroup over the years. We really pride ourselves on creating excellent products that really provide meaningful diagnostic outcomes for our customers and we look to provide the very best support possible in all of the settings. These are the things that drives us today.
The interviewee
Bryce McEuen, BSc Mech Eng, MBA
Managing Director and Business Unit Manager, Biomedical Systems
ELITechGroup, Logan UT, USA

For more information about ELITechGroup visit www.elitechgroup.com

Roche has acquired Enterprise Therapeutics novel TMEM16A potentiator portfolio, which will be developed by Genentech, a member of the Roche Group. The portfolio includes ETD002 which recently entered Phase 1 trials.
Enterprise’s shareholders received an upfront payment of £75 million and are eligible to receive additional contingent payments, to be made based on the achievement of certain predetermined milestones.
The TMEM16A portfolio is focused toward treating all people with cystic fibrosis, with potential to benefit people with other severe respiratory diseases characterised by excessive mucus congestion.
Dr John Ford, CEO, Enterprise Therapeutics, said: “Roche and Genentech have a proven track record of bringing new medicines to people with respiratory diseases, and have recognised the opportunity that our TMEM16A potentiator portfolio presents. I am very proud of the team at Enterprise for identifying and developing this innovative approach to treat patients, with ETD002 the first of our compounds to reach clinical stage. TMEM16A potentiation has the potential to significantly increase the quality of life for people living with cystic fibrosis, for many of whom existing therapies are not effective.”
Dr James Sabry, MD, PhD, Global Head of Pharma Partnering, Roche, commented: “We are excited to add Enterprise’s TMEM16A potentiator program to our existing respiratory portfolio. We have deep capabilities in this area and look forward to a robust program focused on helping cystic fibrosis patients and patients suffering from other muco-obstructive disorders as quickly as possible.”

Using two cell surface markers found to be highly expressed in breast cancer lymph node metastases, researchers at Moffitt Cancer Center, working with colleagues at other institutions, have developed targeted, fluorescent molecular imaging probes that can non-invasively detect breast cancer lymph node metastases. The new procedure could spare breast cancer patients invasive and unreliable sentinel lymph node (SLN) biopsies and surgery-associated negative side effects.
‘The majority of breast cancer patients, up to 74 percent, who undergo SLN biopsy are found to be negative for axillary nodal, or ALN, metastases,’ said corresponding author David L. Morse, Ph.D., an associate member at Moffitt whose research areas include experimental therapeutics and diagnostic imaging. ‘Determining the presence or absence of ALN metastasis is critical to breast cancer staging and prognosis. Because of the unreliability of the SLN biopsy and its potential for adverse effects, a non-invasive, more accurate method to assess lymph node involvement is needed.’
The authors note that the postoperative complications to the SLN biopsy can include lymphedema, seroma formation, sensory nerve injury and limitations in patient range of motion. In addition, biopsies fail to identify disease in axillary lymph nodes in five to 10 percent of patients.
In developing targeted molecular probes to identify breast cancer in axillary lymph nodes, the research team from Moffitt, the University of Arizona and University of Florida used two surface cell markers – CAIX and CAXII. CAIX is a cell surface marker known to be ‘highly and broadly expressed in breast cancer lymph node metastases’ and absent in normal tissues.
CAIX and CAXII are both integral plasma membrane proteins with large extracellular components that are accessible for binding of targeted imaging probes, explained Morse. In addition, several studies have shown that CAIX expression is associated with negative prognosis and resistance to chemo and radiation therapy for breast cancer. CAXII is a protein expressed in over 75 percent of axillary lymph node metastases.
The researchers subsequently developed their targeting agents by using monoclonal antibodies specific for binding CAIX and CAXII, both of which are known to promote tumour growth.
According to the researchers, a number of non-invasive optical imaging procedures for SLN evaluation have been investigated, but the approaches have lacked the ability to target tumour metastasis biomarkers.
‘These methods provide only anatomic maps and do not detect tumour cells present in lymph nodes,’ explained Morse. ‘Using mouse models of breast cancer metastasis and a novel, monoclonal anti-body-based molecular imaging agents, we developed a targeted, non-invasive method to detect ALN metastasis using fluorescence imaging.’
In addition to the imaging study with mice, the researchers also reported that the combination of CAIX and CAXII covered 100 percent of patient-donated samples used in their tissue microarray (TMA) study. Moffitt Cancer Center

Scientists have successfully completed an initial trial of a new, potentially more reliable, technique for screening breast cancer using ultrasound. The team at the National Physical Laboratory (NPL), the UK’s National Measurement Institute, working with the University Hospitals Bristol NHS Foundation Trust, are now looking to develop the technique into a clinical device.
Annually, 46,000 women are diagnosed with breast cancer in the UK, using state-of-the-art breast screening methods, based on X-ray mammography. Only about 30% of suspicious lesions turn out to be malignant. Each lesion must be confirmed by invasive biopsies, estimated to cost the NHS £35 million per year. Ionising radiation also has the potential to cause cancer, which limits the use of X-rays to single screenings of at risk groups, such as women over 50 through the National Breast Screening Programme.
There is a compelling need to develop improved, ideally non-ionising, methods of detecting breast lesions and solid masses. Improved diagnosis would reduce unnecessary biopsies and consequent patient trauma from being wrongly diagnosed.
Ultrasound ticks many of the boxes: it is safe, low cost, and already extensively used in trusted applications such as foetal scanning. However the quality of the images is not yet good enough for reliable diagnoses.
Part of the problem lies with the current detectors used. Different biological tissues have different sound speeds, and this affects the time taken for sound waves to arrive at the detector. This can distort the arriving waves, in extreme cases causing them to cancel each other out. This results in imaging errors, such as suggesting abnormal inclusions where there may be none.
The new method works by detecting the intensity of ultrasonic waves. Intensity is converted to heat that is then sensed by a thin membrane of pyroelectric film, which generates a voltage output dependant on the temperature rise. Imaging detectors based on this new principle should be much less susceptible to the effects caused by the uneven sound speed in tissues.
This technique, when used in a Computed Tomography (CT) configuration, should produce more accurate images of tissue properties and so provide better identification of breast tissue abnormalities. The aim of tomography is to produce a cross-section map of the tissue, which describes how the acoustic properties vary across the tissue. Using this map, it is possible to identify abnormal inclusions.
An initial feasibility project has proved the concept by testing single detectors using purpose-built artefacts. These artefacts were designed to include well-defined structures, enabling the new imaging method to be compared with more conventional techniques. The results confirmed that the new detectors generated more reliable maps of the internal structure of the artefacts than existing techniques.
Having received positive results and proven the potential of the project, NPL is now seeking funding to develop the work further. They hope to produce a demonstrator using a full array of 20 sensors, which should allow more rapid scanning and move the idea towards a system which might eventually be used clinically. It is hoped that this will provide both a suitable resolution and fast enough scanning to become a viable replacement for current clinical scanners. Following successful completion of the demonstrator, NPL and partners will look to work with a manufacturer to commercialise the technology. EurekAlert