by Pauline Griffeuille and Dr Sylvain Dulaurent
People driving under the influence of drugs do not only risk their own health but also endanger other road users. The results of the roadside tests performed by the police have to be double-checked in a laboratory, which is currently time consuming and costly. Here, a new testing method is described which provides results in a time- and cost-saving way using oral fluid samples.

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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.”

A Jackson Laboratory research team led by Professor and Howard Hughes Medical Investigator Susan Ackerman, Ph.D., has discovered a defect in the RNA splicing process in neurons that may contribute to neurological disease.
The researchers found that a mutation in just one of the many copies of a gene known as U2 snRNAs, which is involved in the intricate processing of protein-encoding RNAs, causes neurodegeneration.
Many so-called non-coding RNAs—those that don’t directly encode proteins—are found in multiple copies in the genome, Ackerman says. ‘These copies are identical, or nearly identical, so conventional wisdom suggested they were redundant. For the first time, we show that a mutation in one copy can lead to disease.’
The results suggest that disease-causing mutations may exist among other repetitive genes. ‘This opens up a whole new way of studying these RNAs,’ Ackerman notes, ‘including the types of disruptions in RNA processing that can lead to degeneration.’
Neurons, like most other cells, build the workhorse proteins that carry out vital functions from the genetic ‘blueprint’ encoded in DNA. In broad strokes, DNA gets copied by pre-messenger RNA (pre-mRNA), then pre-mRNA undergoes a splicing process before transporting the genetic code to the ribosome, where proteins are manufactured. But there’s much more to it than that.
Specialized RNAs called U-snRNAs are essential to the splicing process. U-snRNAs are highly conserved, meaning that they are found all along the evolutionary pathway from simple organisms to humans. Ackerman showed that mutations in one form of snRNA, known as U2, lead to movement problems and early neuron death in mice.
U2 is a repetitive gene, meaning there are many copies of the same sequence. A mutation in just one copy led to the observed disorders by disrupting alternative splicing events, part of the splicing process that normally allows the creation of two or more protein forms from the same stretch of pre-mRNA.
The error leads to production of mRNAs containing regions known as introns that should have been removed. These abnormal mRNAs cause cell death, either through active toxicity or the production of dysfunctional proteins. Moreover, the researchers noted that the severity of the splicing abnormalities and cell death depend on the ‘dosage’ level of the mutant gene.
Also, Ackerman and her lab noted that the highest levels of the mutant U2 were found in the cerebellum of the brain, indicating that the expression of mammalian U2s, previously thought to be universal, may be different among various cell types. The Jackson Laboratory

Sickle cell disease is a group of inherited blood disorders caused by genetic mutations in the beta-globin gene, resulting in abnormal haemoglobin. Red blood cells become hard, sticky and sickle-shaped, with reduced ability to carry oxygen. Symptoms of sickle cell disease include swelling of the hands and feet, pain due to clogging of blood vessels, anaemia and stroke. The disease can be cured with stem cell or bone marrow transplants, but there is a high risk that recipients of transplants will reject the donated marrow or cells, which can result in serious side effects and even death.
Researchers at the Salk Institute for Biological Studies in the US have now developed a way to use patients’ own cells to potentially cure sickle cell disease and many other disorders caused by mutations affecting haemoglobin. To do that, they used a two-step approach. First, they took adult skin cells from a patient with a beta-globin mutation that causes sickle cell disease. They used six genes to coax these cells to revert to iPSCs, which could then be developed into blood cells. The genes were introduced into the cells using a technique that avoids the use of viruses and insertion of transgenes into the cells’ genome. Their next step was to repair the beta-globin gene mutation in the stem cells. To swap the defective gene with a normal copy in the iPSCs, the investigators used a modified adenovirus that, unlike viruses used in other methods, does not replicate itself in the body and does not alter the host cells’ DNA. The viral genes were deleted and replaced with a DNA sequence that contained a normal beta-globin gene. The modified virus then delivered the new genetic material inside the iPSCs, where the DNA region containing the broken gene was replaced with the sequence containing the normal gene. By replacing a relatively large region of DNA, the technique allows many gene mutations to be repaired at once.