by Dr Andrew Lane The emergence of SARS-CoV-2 and its global proliferation has spurred unprecedented efforts by academia and the in vitro diagnostics industry to develop rapid tests that can be used for point-of-care (POC) testing. At the time of writing, over 200 rapid test kits are under development or have already been commercialized for use. Yet, owing to relaxation of regulatory standards and the unprecedented pace at which tests have been developed, many have not been adequately assessed. In this article, Dr Andy Lane explains the role of POC diagnostics for COVID-19 and the improvements needed for their widespread use, including the importance of high-quality reagents.
by Dr Jacqueline Gosink The autoimmunogenic myositides (idiopathic inflammatory myopathies, IIM) constitute a group of systemic autoimmune rheumatic diseases that are characterized by chronic inflammation of muscles. Unfortunately, the general misdiagnosis rate is high resulting in a delay to diagnosis of several years. Moreover, a significant proportion of patients with IIM suffer from a generalized feeling of severe illness due to the damage caused by both the disease and its treatment. Autoantibodies are useful biomarkers to differentiate clinically indistinguishable subforms of IIM. Despite the low prevalences and isolated occurrence of many autoantibodies in IIM, they constitute the basis for serological diagnostics. The diagnostic information is maximized by employing comprehensive multiparametric assays covering both myositis-specific and myositis-associated autoantibodies.
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by Pauline Griffeuille and Dr Sylvain Dulaurent Mass spectrometry (MS) can be combined with a number of chromatographic separation and ionization methods, which results in powerful technologies for both qualitative and quantitative molecular analysis. CLI caught up with Dr Bhattacharyya (Thermo Fisher’s Senior Manager for Clinical Research and Toxicology) to find out more about the past, present and potential future uses of MS in clinical science and diagnostics.
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Expert opinions from Dr Ewan Chirnside The diagnosis and treatment of urinary tract infections (UTIs) is currently a balance between starting empirical treatment immediately or waiting a minimum of 48|hours to begin treatment based on the results of pathogen identification and antibiotic susceptibility testing, which provides better antibiotic stewardship but prolongs patient suffering. As part of this issue’s focus on Urine Analysis, Dr Ewan Chirnside (Director of Research Collaborations and co-founder of ODx Innovations, Inverness, UK) shares his knowledge of UTI diagnostics.
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by Dr Samar Soliman and Prof. Chandra Mohan Lupus nephritis is diagnosed with a renal biopsy. Unfortunately, a biopsy is invasive and cannot be serially repeated. Researchers are finding that proteins in the urine may have the potential to predict the ongoing pathology within the kidneys. Studies show that such urine biomarkers may have the potential to predict current and future disease outcome in this disease. Given that there may be many hundreds to thousands of proteins in the urine, how does one identify the most predictive of these candidates? Here we discuss three very different technologies that have contributed to this effort over the past year.
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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.
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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.
https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-12-23 00:05:002021-01-18 14:47:44Monocyte distribution width: new biomarker for sepsis diagnosis
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
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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.”
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