by Dr Jia-he Bai, Prof. Yong-peng Yu and Dr Ya-li Zheng
The diagnosis of early-stage Parkinson’s disease (PD) is still a worldwide clinical problem: it is necessary to identify a biomarker to aid the diagnosis of early-stage PD. This article discusses the current worldwide research progress of kynurenine and PD, in order to provide new directions and ideas for clinical and scientific research.
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.
by Dr Elena Sukhacheva
Early diagnosis and fast treatment of sepsis is crucial for obtaining the best outcome possible for the patient. However, diagnosis is not easy clinically and the complexity of the condition means that there is not an obvious individual biomarker for it. However, research in recent years has shown that monocyte distribution width is an easily measured parameter that is able to discriminate sepsis from non-sepsis, particularly when combined with the patient’s white blood count.
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.
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.
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.
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.
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.
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.
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.
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
Thermo Fisher Scientific has established new collaborations of the Thermo Fisher Precision Medicine Science Center (PMSC) with AstraZeneca and the University of Nebraska Medical Center as part of its ongoing development of innovative solutions for unmet needs in clinical biomarker discovery. The new alliances strengthen the PMSC’s mission of creating standardized workflows with pharma and academic partners to streamline the transition from biomarker research to clinical implementation, creating new opportunities for precision medicine.
Ongoing and planned studies with both AstraZeneca and the University of Nebraska Medical Center will utilize standardized plasma protein profiling workflows, including Thermo Fisher’s newly developed ultra-high throughput plasma protein profiling (uHTPPP) workflow, for biomarker discovery, for a range of conditions. The standardized workflows consist of automated sample preparation for untargeted and targeted methods in combination with the Thermo Scientific Orbitrap Exploris 480 and Thermo Scientific Orbitrap Exploris 240 mass spectrometers.
“Precision medicine is becoming a greater area of interest across a range of different diseases and has, therefore, faced challenges effectively scaling to meet clinical needs,” said Emily Chen, senior director, PMSC. “The goal of the Precision Medicine Science Center is to construct end-to-end workflow solutions that generate impactful data from discovery studies with large human cohorts and to harness the power of molecular profiling to improve the outcomes of patient care. Our ongoing work with AstraZeneca and the University of Nebraska Medical Center are paramount to realizing the potential of these technologies.”
Ventzi Hristova, senior scientist, dynamic omics, antibody discovery and protein engineering, R&D at AstraZeneca, said: “Powered by technological innovation, omics is proving to be one of the richest sources of data in all of science. Clinical proteomics is an emerging field aimed at improving patient care through the development of sensitive, high-throughput methods for in-depth proteomic characterization of clinical samples. This collaboration aims to evaluate and establish a model for clinical proteomics, using advanced sample processing and downstream analytical applications, that has the potential to help us identify new drug targets and biomarkers.”
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.”
‘The overactive bladder syndrome has become an accepted way to simplify a complex array of symptoms and leads people to believe that an overactive bladder is an independent disease in itself. However, the truth is not as simple as this, as there are usually several factors at work explaining the symptoms. This is also one of the reasons why so called overactive bladder medications often do not bring the hoped result,’ says Kari Tikkinen, MD, PhD, from the HUCS Department of Urology.
The article on overactive bladder syndrome, which was co-written by Tikkinen, who currently holds a senior researcher post at the McMaster University in Canada, and Anssi Auvinen, Professor of Epidemiology from the University of Tampere, was recently published. For the article, the researchers systematically reviewed the studies on overactive bladder and the channels through which these studies have been funded.
The authors argue that the symptoms of an ‘overactive bladder’ ought to be studied individually and not as an ambiguous constellation of symptoms. This way the underlying causes of the symptoms can be better understood and more effective treatments can be developed.
The expression ‘overactive bladder’ was coined at an industry-sponsored symposium held in 1997. The following year, the FDA approved the first drug for the treatment of ‘symptoms of overactive bladder’, after which the pharmaceutical industry launched high-profile, worldwide promotional campaigns for drugs aimed at treatment of the syndrome.
According to the current definition, overactive bladder (OAB) syndrome is defined as the presence of urinary urgency with or without urgency incontinence, usually with increased daytime frequency and nocturia in the absence of infection or other obvious pathology.
‘The definition is vague and ambiguous because it includes unspecific terms, such as ‘usually’ and ‘with or without’, and the unclear expression ‘other obvious pathology’,’ Tikkinen says and continues, ‘For the pharmaceutical industry this definition is probably quite useful, as it is partly the reason why one medicine can be prescribed to a large number of patients.’
Research into overactive bladder has increased significantly over the past ten years and the pharmaceutical industry has invested heavily in it. ‘It has previously been shown that research funded by commercial actors often ends up unpublished if the results don’t serve the interests of the company,’ Tikkinen points out.
Tikkinen and Auvinen also bring to the fore that in many studies on prevalence of overactive bladder, very mild symptoms have been classified as abnormal.
‘More independent, non-commercially funded research on the subject is needed. There are, in the end, a huge number of people who suffer from urinary urgency and increased urinary frequency, and current treatments are not bringing sufficient relief,’ Tikkinen says.
EurekAlert
A new study from researchers at Queen Mary, University of London shows how a particular virus tricks the immune system into triggering inflammation and nerve cell damage in the brain, which is known to cause MS.
Previous research has suggested a link between the Epstein-Barr virus (EBV) and multiple sclerosis but the research has remained controversial since scientists have so far failed to substantiate the link.
The new study proves the virus is involved in a manner more sophisticated and subtle than previously imagined, and may offer new ways to treat or prevent the disease.
MS is a neurological condition that affects around 100,000 people in the UK. It can cause vision problems, difficulties with walking and fatigue, and tends to strike mainly young and middle-aged women.
Its causes are not completely understood but both genes and environment are known to play a role.
Some previous research has suggested that EBV triggers MS but subsequent studies have failed to find the connection.
The new research looked at post mortem brains of MS patients, examining areas where neurological damage had recently occurred.
Dr Ute-Christiane Meier from Barts and the London Medical School, part of Queen Mary, led the research. She explained: ‘EBV is quite a clever virus; when it’s not growing and spreading it can hide away in our immune cells.
‘In this study we used a different technique which allowed us to detect the virus in the brains of some people affected by MS, even when it was hiding away in the cells.’
Dr Meier and her team of collaborators found that, although the virus was not actively spreading, it was releasing a chemical message into areas of the brain nearby. This chemical message – made up of small RNA molecules – was activating the body’s immune system, causing inflammation. This damages nerve cells in the brain and causes MS symptoms.
Dr Meier continued: ‘We have to be careful and have to study more MS brains but this is potentially very exciting research. Now we understand how EBV gets smuggled into the brain by cells of the immune system and that it is found at the crime scene, right where the attack on our nervous system occurs. Now we know this, we may have a number of new ways of treating or even preventing the disease.’
One possibility is the widely-used cancer treatment Rituximab; a drug which is known to kill the cells of the immune system in which the virus hides. It is now being trialed as a treatment for MS.
Another possible approach, using anti-viral treatment, will be tested in clinical trials currently in preparation by Professor Gavin Giovannoni and colleagues, also at Queen Mary.
‘If we can pinpoint EBV as a trigger, it’s possible that we could alter the course of MS or potentially even prevent the condition by treating the virus,’ Dr Meier added.
‘MS so often strikes young women and its unpredictable nature makes it an incredibly difficult disease to live with. We desperately need better ways to tackle the condition.’
Interestingly, the research also hinted that infection with EBV and its action on the immune system could also be playing a role in other brain diseases such as cancer and stroke.
Queen Mary, University of London
New research from Queen Mary, University of London has uncovered a gene which plays a key role in the development of oesophageal cancer (cancer of the gullet).
The researchers studied families who suffer a rare inherited condition making them highly susceptible to the disease and found that a fault in a single gene was responsible. Initial studies suggest that the gene could play a role in the more common, non-inherited form of the disease, revealing a new target for treating this aggressive type of cancer.
Oesophageal cancer affects more than 8,000 people each year in the UK and rates are rising. It is more common in the UK than anywhere else in Europe.
Survival rates are poor compared to other types of cancer with only eight per cent of people alive five years after diagnosis. Scientists know little about how oesophageal cancer develops and very few drugs for targeting the disease are currently available.
The new study was led by Professor David Kelsell from Barts and the London Medical School, Queen Mary, University of London with collaborators from the University of Dundee and the University of Liverpool.
The research concentrated on three families with a hereditary condition called tylosis with oesophageal cancer. This condition affects the skin and mouth and sufferers have a 95 per cent chance of developing oesophageal cancer by the age of 65.
The research revealed that all three families carried a faulty version of a gene called RHBDF2.
Experiments showed that this gene plays an important role in how cells that line the oesophagus, and cells in the skin, respond to injury. When the gene is functioning normally it ensures that cells grow and divide in a controlled fashion to help heal a wound.
However, in tylosis patients’ cells, and in cells from oesophageal cancers, the gene malfunctions. This allows cells to divide and grow uncontrollably, causing cancer.
Professor Kelsell explains: ‘In studying this relatively rare condition, we have made an important discovery about a cancer that is all too common. Finding a genetic cause for this aggressive cancer, and understanding what that gene is doing, is an enormous step forward.
‘By analysing the complex biology which causes a particular type of cancer we begin to understand which treatments might be effective and also which treatments are unlikely to help.’
Queen Mary University of London
The Center for Human Genetics and Laboratory Medicine Dr. Klein and Dr. Rost, and IMGM Laboratories, both located in Martinsried Germany, reported using the Roche GS Junior Benchtop System to sequence clinically relevant exons and identify genomic variations in solid tumors treated with an antibody-based medicine. This sequencing approach, easily expanded to complete coding regions, has great potential for personalized medicine, where individual treatment success is largely dependent on the mutation status of tumor genes. The high-quality long reads produced by the GS Junior System enable accurate and comprehensive analysis of the full range of genetic variations.
Personalized tumor treatments, such as monoclonal antibodies (mAb) that specifically target tumor-inducing proteins, require a precise and comprehensive assessment of an individual’s genetic profile for the targeted genes. Current therapies target only a limited region of the relevant tumor genes, whereas the next-generation GS Junior Sequencing System enables cost effective and comprehensive profiling of all the relevant genes. In contrast, conventional capillary sequencing techniques often lack the sensitivity and cost effectiveness to detect tumor mutations occurring at less than 20% frequency.
“The future of personalized tumor treatment lies in this sequencing approach,” said Dr. Hanns-Georg Klein, MD, CEO of both IMGM and the Center for Human Genetics. “Through our research, we’ve found that it’s critical to ensure a comprehensive analysis of a tumor variant population, including known and novel mutations.”
These findings underscore the utility of Roche’s GS Junior System for investigating complex tumor samples. The long, accurate sequencing reads are ideal for identifying multiple tumor mutations that can include structural variations and rare somatic mutations.
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March 2026
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