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Clinical Laboratory int.

Archive for category: E-News

E-News

Pilot study of five-hour molecular test accurately distinguishes malignant and benign breast tumours

, 26 August 2020/in E-News /by 3wmedia

A team led by Johns Hopkins Kimmel Cancer Center investigators reports that a new laboratory test they developed to identify chemical changes to a group of cancer-related genes can accurately detect which breast tumours are cancerous or benign, and do it in far less time than gold-standard tests on biopsied breast tissue.
Although the findings are preliminary and need further validation in larger groups of people, the investigators say the test has the potential to dramatically reduce the time (minimum by one month, maximum by 15 months) generally needed to make a definitive breast cancer diagnosis in poorer countries.  A quick diagnosis has already been definitively proven to boost survival for all cancers by reducing wait times to surgical and other treatments. A report on the test, which exploits the tendency of some cancer-related genes to undergo the attachment of a chemical group, by a process known as methylation, has been published.
“Diagnosis is a huge bottleneck to starting treatment, especially in developing countries that have a small number of pathologists available to review breast cancer biopsies who serve a huge population,” says study leader Saraswati Sukumar, Ph.D., professor of oncology and pathology at the Johns Hopkins Kimmel Cancer Center.  “That means a test like ours could be especially useful in places with fewer resources and where mortality rates from breast cancer are much higher compared to the developed world.”
Breast cancer cases are rising around the world, Sukumar notes. Globally, breast cancer incidence is steadily increasing. In 1980, GLOBOCAN reported 641,000 new cases of breast cancer worldwide. In 2018, the estimated incidence of breast cancer worldwide rose to 2.1 million cases (a 3.2% annual rate of increase) with 626,000 deaths due to this cancer.
The reasons for higher death rates in the developing world include social stigmas that prevents many women from seeking timely treatment and a lack of healthcare resources. However, a major factor is time between biopsies and delivery of a diagnosis, which can be as long as 15 months in places with fewer resources compared to a few days or weeks in the United States.  
Seeking to shrink the time from biopsy to diagnosis, Sukumar and her colleagues in the Johns Hopkins Kimmel Cancer Center, Johns Hopkins University School of Medicine’s departments of pathology, surgery, and radiology, and the Johns Hopkins Bloomberg School of Public Health and collaborators from Cepheid developed a novel technology platform.  Here, a patient’s biopsy sample is loaded into cartridges and inserted in a machine that tests levels of gene methylation—a chemical addition to genes that results in changes in gene activity. This platform returns methylation marker results within five hours.
These results suggest that the test holds promise as a “first pass” to distinguish between malignant and benign breast tumours, Sukumar says. With the 5-hour-long return on results, low skill required to run the test, and relatively low expense, it could offer hope of speeding diagnosis for thousands of women worldwide.
Sukumar cautions that the team’s molecular test cannot replace expert analysis by a pathologist, whose skill will be necessary to review core biopsies of the breast lesion for a definitive diagnosis and optimal therapy recommendations.
John Hopkins University https://tinyurl.com/yxkg5sjy

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Introducing new tests to a laboratory’s repertoire

, 26 August 2020/in Corona News, E-News /by 3wmedia

Expert opinions from Dr Heidi Mendoza
There are many assessments to make when adding a new test to a lab’s collection. Dr Heidi Mendoza, acting consultant clinical biochemist at Raigmore Hospital, Inverness, UK, shares her experiences and observations of doing exactly that in both ordinary circumstances and during a pandemic, as well as having to contend with the geographic challenges imposed by the nature of life in the Scottish Highlands.
Can you provide a little background about yourself and where you work, please?
I am a clinical biochemist based in Raigmore Hospital, which is a small hospital in the Scottish Highlands. In my current role I provide clinical advice and interpretation for biochemistry tests for general practitioner (GP) practices and three hospitals across the Highlands. Working in the Highlands is incredibly rewarding, but also very challenging! It can take between 2 and 6|hours to travel between hospitals and our patients may have to travel by plane or boat to be seen, with journey times of +12|hours depending on where they live. It really puts the laboratories under pressure to get it right for the patient. Repeat testing isn’t as simple or straightforward as it would be in a city and we have to have excellent systems in place for reporting critical results and getting patients into hospital or transferring them between hospitals. Getting the right test, in the right place, with the right turnaround time is really important for our patients and for our clinicians.
What are the usual circumstances in which you would think about bringing a new test into the lab’s repertoire?
Any new test is a cost pressure on our National Health Service (NHS) and can only be brought in when it demonstrates clear benefits for patients. We have brought in two new tests in the last 12|months that are good examples of the different ways we can bring in new tests to our laboratory.
The first test is the NT-proB-type natriuretic peptide (NTproBNP) test. NTproBNP is used to investigate patients with suspected heart failure and the results can be used to determine whether a patient needs an echocardiogram (ECHO) or not. If they do need an ECHO the NTproBNP result can be used to split patients into those who need urgent ECHO (2|weeks) or routine ECHO (6|weeks). In theory this is a perfect test to implement as it will benefit patients and is cost-effective with respect to the more expensive ECHO investigation. However, NTproBNP has been implemented in other hospitals without reducing ECHO waiting times or the number of ECHOs performed! To ensure that this didn’t happen in our service, I spent 6|months before implementation of the test liaising with cardiologists and GP representatives from across the Highland region. We changed the ECHO referral pathway to include NTproBNP and created useful guidance for GPs on when to, and importantly when not to, request NTproBNP. We implemented the test just under 1|year ago and have seen a positive effect on ECHO referrals. We will still have to attend a 1|year post-implementation review with the Hospital Board to present our audit data and show that investment in the service by introducing a new test has benefited patients and other areas of the service.
Procalcitonin is the second example. Procalcitonin is a test that can be used in the investigation of sepsis and guide the use of antibiotics. Procalcitonin was not a test available in our hospital before the COVID-19 pandemic. Procalcitonin is not increased in the majority of adult patients with COVID-19; however, an elevated procalcitonin may suggest superimposed bacterial infection and be used to guide treatment of these patients and improve patient outcomes. Early in the COVID-19 pandemic we were approached by our Intensive Care Unit (ITU) and Microbiology consultants who requested that procalcitonin be available for our COVID-19 patients in ITU to guide their antibiotic treatment. We implemented procalcitonin in less than 4|weeks with help from our instrument manufacturer, external quality assessment providers and other Scottish hospitals who provided anonymized patient serum with known values so that we could verify our assay as quickly as possible. We are now in the process of putting together a business case and following the evidence base which will determine whether we continue to offer the procalcitonin test.
How would you usually go about adopting a new test?
As highlighted in the two examples above, we must agree a clinical need for a test and then liaise with the users of the service to find out how the test should be implemented into the patient-care pathway. Once we have worked out the clinical utility of the test, then we can carry out the laboratory verification of the test and the laboratory workflow. Verification is very straightforward. For example, the between-batch and within-batch precision, accuracy, linearity on dilution, interferences and sample stability for a test need to be evaluated. The implementation of the test then must be followed by an audit which shows that the test is being used as intended and giving the benefits predicted. If not, the test may need to be withdrawn. The hardest part of the entire process is agreeing how a test is going to be used and fitting it in to the patient-care pathway.
In the situation of the COVID-19 pandemic, we have a new disease, caused by a new virus, and new tests that have been created very quickly. How do you start to use a new test in these circumstances – are there any differences in procedure?
There is no difference in the steps that need to be performed we just need to be able to do everything in a much shorter time frame. That is actually much easier than it sounds. In the NHS, the laboratories from different parts of the country are great about helping other laboratories. We regularly share protocols, data and learning. If a new test is released we’ll contact another laboratory and they’ll share their local experience and any problems they have had with the test.
For procalcitonin implementation I contacted the laboratory in Dundee, UK, and they helped us out by lending us kits and reagents, sending us anonymized patient serum with known procalcitonin values, and sharing their data and verification protocols. This allowed us to complete verification incredibly quickly. We will still have to gather the data and evaluate whether the test is providing the benefit that we predicted when we established the clinical need.
What are the challenges regarding validation, reference levels, results interpretation and reporting?
Verifying tests is straightforward as we are always evaluating tests in clinical laboratories so are very experienced. Results interpretation can be quite difficult. If we need clinicians to change patient management based on a result then we have to provide them with very clear local guidance on what we want them to do with a result. This might be different from the action they would take in another hospital with different patient pathways, different pressures on patient turnaround times, and different diagnostic facilities. This is where good working relationships with users of the service are key to test implementation. If you just implement a new test without working out where it fits in the patient pathway, it doesn’t matter how great the test is, as it is unlikely to be used well and may not improve patient care.
What do you have to think about in terms of logistics?
Many laboratories are understaffed due to a combination of unfilled vacancies and staff on long-term absence. The additional work involved in verifying and implementing a new test does put pressure on staff. However, NHS laboratory staff are highly trained and dedicated. When the staff know how a test is going to be used and the benefit to the local community, they support the implementation and the extra work involved.
Biocontainment and staff safety have been important considerations during the COVID-19 pandemic. We had to adhere to government guidance in the transport, analysis and disposal of samples from patients with suspected COVID-19. This changed laboratory workflows and slowed us down, creating longer turnaround times.
Logistics are a serious consideration for us owing to our geography. Reagent shortages or delays in deliveries have a big impact on small laboratories as they can’t store much surplus reagent stocks because of expiry dates. Unexpected overuse or underuse of a new test can be quite challenging and leave the laboratory short of tests or with expired, wasted kits. There are also several times during the year when the roads are impassable between our central and rural laboratories. We have been down to single numbers of tests remaining several times over the last few years or had failed delivery from manufacturers in winter. There was also a shortage of procalcitonin reagent as there was such a surge in the use of the test during the COVID-19 pandemic. Again, working closely with users of our laboratory services has enabled us to rationalize the use of the test until the global shortage of reagent ended. On a number of occasions we have also shared reagents with other Scottish laboratories to ensure that none of the laboratories were left without reagents.
What has been learnt from the current coronavirus situation about diagnostic testing during a pandemic that would help to improve the process in future?
The coronavirus pandemic has shown how robust the infrastructure of the NHS is in Scotland and how adaptable laboratories can be when required. The laboratories really pulled together and worked towards a common goal delivering testing to COVID patients and non-COVID patients during a crisis. The two things that made this possible were: (1) Having a very clear goal – delivery of a service with new testing during a pandemic; and (2) Finances changes which needed to be made to deliver the service got rapid financial approval. How do we take these lessons learned and apply it to the routine delivery of laboratory services? Finance will always be a limiting factor – as it should be! Healthcare is expensive and it is up to us as healthcare professionals to deliver a cost-effective and affordable service. In contrast, having a clear goal, is definitely something that we could do better in the future. In the case of the pandemic, laboratories found different solutions based on local geography, resources and incidence of COVID. The changes made by laboratories in the remote Highlands and Islands were similar, but different than those made by laboratories in major cities. The staff that delivered the service found the best solutions to the goals set by the government – that is the real lesson we need to take away. We need to give very clear goals to services and let local expertise and knowledge drive the changes to solve the problem.
The expert
Heidi Mendoza BSc MSc PhD RCPath
Blood Sciences Department, Raigmore Hospital, Inverness IV2 3UJ, UK
E-mail: heidi.mendoza@nhs.net

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Cobra Biologics and the Karolinska Institutet collaborate to develop COVID-19 vaccine

, 26 August 2020/in Corona News, E-News /by 3wmedia

Cobra Biologics (Cobra), an international contract development and manufacturing organization (CDMO) for biologics and pharmaceuticals, and the Karolinska Institutet (KI), one of the world’s leading medical universities, announced 30 March they have been awarded €3 million emergency funding by Horizon 2020 for research and development, and phase I clinical trial testing of a DNA vaccine against COVID-19, as part of the OPENCORONA consortium to support global efforts tackling the pandemic. Partners in the consortium also include Karolinska University Hospital, Public Health Authority (FoHM), IGEA, Adlego AB and Giessen University.
The project is called OPENCORONA and the application, ‘Rapid therapy development through Open Coronavirus Vaccine Platform’, was one of the first two to be successfully selected by the European Commission, with 17 applications chosen out of 91, receiving €47.5 million in total. The aim of the project is to manufacture a DNA vaccine, which will be delivered to patient muscle to generate a viral antigen on which the immune system then reacts. The ‘open’ project will utilise Cobra’s 50L DNA suite in Sweden to produce the plasmid DNA. The plasmid production will support the vaccine development process in accordance with GMP and with a new kind of ‘open’-ness that will help to speed the fight against COVID-19 by making relevant data and research results available to the wider scientific community.
KI notes that “genetic analysis shows that the SARS-CoV-2 envelope and receptor binding domain only has a 75% homology with other human coronaviruses. Thus, existing immunotherapies and vaccine candidates against other coronaviruses, such as SARS, will not be useful against SARS-CoV-2. We will use the DNA vaccine platform as this is currently the most rapid and robust vaccine platform. We have generated several chimeric SARS-CoV-2 genes and will select for the most potent DNA vaccine/immunotherapy candidate delivered by in vivo electroporation that protects against SARS-CoV-2 infection and/or disease in animal models and take this to phase I clinical testing.”
To date, no approved human COVID-19 immunotherapy or vaccine exists, and in response to the outbreak, speed in therapy and vaccine R&D is critical. Harnessing each partner’s expertise and experience in reliable development manufacturing, the OPENCORONA consortium is using the DNA vaccine platform as it is currently one of the most rapid and robust vaccine platforms available. First trials in humans will begin in 2021, and will take place at the Karolinska University Hospital.
Commenting on the funding, Matti Sällberg, Head of Department of Laboratory Medicine, Karolinska Institutet, commented: “The need to find an effective vaccine is urgent and we are working as quickly as possible to find one. With this funding from the EU we will have secured a significant part of the financing going forward, which means that we can focus entirely on the research. It is a relief to know that we are now financed all the way to studies in humans.”

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Horiba Yumizen hematology analysers minimize microscopy slide reviews

, 26 August 2020/in E-News /by 3wmedia

Horiba has recently announced the publication of scientific studies which demonstrate the excellent performance of its new HELO high throughput fully automated hematology platform on body fluid and pathological samples. Horiba’s Yumizen® H2500 and H1500 automated hematology analysers within the HELO platform deliver enhanced precision for complete blood counts and white blood cell (WBC) differential testing, with body fluid analysis included as standard. This improves diagnosis, minimizes unnecessary manual microscopy slide reviewing and enhances laboratory workflow, as highlighted by two recent scientific evaluation studies.
The first study was undertaken by Nantes University Hospital (CHU de Nantes) focusing on the need for automated analysis of biological fluids for robust and reliable results reporting. Hematological analysis of body fluids (BF) can provide clinicians with valuable diagnostic information as it can indicate a number of serious medical conditions. Manual microscopy has traditionally been used to determine total and differentiated WBC in BFs, however, results can be affected by inter-operator variability and take time to undertake. By using an automated method of analysis of WBC in a body fluid smear, this can improve turnaround times and accuracy.
To ensure the robustness and reliability of automated BF analysis in routine laboratory workflows, the evaluation study was undertaken on the performance of the automated body fluid analysis cycle on the Yumizen H2500. The study included 98 samples from cerebro-spinal, pleural, ascitic, pericardic and bronchoalveolar liquid (BAL) fluids which were used for comparative leukocyte and erythrocyte counts, as well as differential. This confirmed the good analytical performance of Yumizen analyser in comparison with conventional microscopic count, as well as a reference analyser.
The second study explored the flagging efficiency of the new analyser. Pathological samples, coming from patients with altered hematopoiesis, often trigger a WBC-Diff flag; this is due to poor cell separation and requires a manual slide review (MSR) by microscopy to confirm the WBC differential. Laboratory workload would be optimized if MSR could be reduced without compromising patient care. Therefore, the study undertaken by the Institut Bergonié Comprehensive Cancer Centre compared the flagging performance in the WBC differential of the Yumizen H1500/H2500 to a routine analyser. This included patients with pathology or treatment affecting hematopoiesis, such as those undergoing chemotherapy or with onco-hematologic disorders.
The study on 228 pathological samples (100 from patients on chemotherapy for solid tumours and 128 from patients with malignant blood disease) demonstrated an improvement in the WBC-diff analysis and reliability of the Yumizen H1500/2500 analyser compared to a routine analyser. It delivered better precision and specificity, due to improved cell separation, and a significant decrease (-21%) in unnecessary morphology reviewing by microscopy, thus saving significant time in the laboratory.
Commenting on the successful outcome of the studies, Mandy Campbell, Horiba Medical said, “These evaluation studies undertaken by recognized authorities in hematological analysis, demonstrate the excellent performance of our new Yumizen H1500/H2500 automated hematology analysers with both body fluid and pathological samples. Body fluid analysis is available as standard on these analysers which have been shown to enhance diagnoses and lower film review rates to improve laboratory workflow.” www.horiba.com/medical

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Avacta ships SARS-COV-2 Affimer reagents to Cytiva and Adeptrix for diagnostic test development

, 26 August 2020/in Corona News, E-News /by 3wmedia

Avacta Group plc, the developer of Affimer biotherapeutics and reagents, has started shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners.
The Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva based COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States.
The Affimer reagents have been manufactured by Avacta in the quantities required for test development and are being sent to Cytiva. The reagents are also being provided to Adeptrix with whom Avacta has announced that it will develop a COVID-19 laboratory test to run on hospital mass spectrometers using Adeptrix’s proprietary BAMS assay platform.
The Affimer reagents have been studied further by Avacta and this has shown that there are Affimer reagents that can work in pairs, both binding to the spike protein at the same time. This allows tests to be developed that detect both the intact virus particle and the detached spike proteins which become separated from the virus particle during the development of the COVID-19 disease, which may also be important in monitoring disease progression.
Cytiva and Avacta will now work to develop rapid test strips for the detached spike protein and for the intact virus particle. Adeptrix is working to develop a prototype BAMS test. Both of these tests will indicate whether a person has the infection at that moment.

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Siemens Healthineers awarded FDA approval for RAPIDPoint 500e Blood Gas Analyzer

, 26 August 2020/in Corona News, E-News /by 3wmedia

Siemens Healthineers’s latest critical care testing solution, the RAPIDPoint® 500e Blood Gas Analyzer, has received clearance from the U.S. FDA, and is now available in the U.S., Europe and countries requiring the CE mark. The analyser generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.
The RAPIDPoint 500e Blood Gas Analyzer is an essential instrument supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation. Arterial blood gas tests provide the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required.
“The RAPIDPoint 500e Blood Gas Analyzer has become a trusted instrument in Europe’s endeavour to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients,” said Christoph Pedain, Head of Point of Care Diagnostics, Siemens Healthineers.
“Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important.”
The analyser elevates confidence in patient results with Integri-sense Technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Additionally, the RAPIDPoint 500e Analyzer integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers convenient, remote management of operators and devices located across multiple sites.
Commenting on the device, Dr. Daniel Martin, Royal Free Hospital, London, said: “As an ICU physician, I know that the values I am handed during an emergency allow me to confidently make life-saving decisions. The RAPIDPoint system is easy to use and allows me to not worry about the machine and focus my attention on my patients.”

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Improved understanding of the pathology of dwarfism may lead to new treatment targets

, 26 August 2020/in E-News /by 3wmedia

Pseudoachondroplasia (PSACH) is a severe inherited dwarfing condition characterised by disproportionate short stature, joint laxity, pain, and early onset osteoarthritis. In PSACH, a genetic mutation leads to abnormal retention of cartilage oligomeric matrix protein (COMP) within the endoplasmic reticulum (ER) of cartilage-producing cells (chondrocytes), which interferes with function and cell viability. In a report, investigators describe how this protein accumulation results in “ER stress” and initiates a host of pathologic changes. These findings may open up new ways to treat PSACH and other ER-stress-related conditions.

“This is the first study linking ER stress to midline 1 protein (MID1), a microtubule stabilizer that increases mammalian target of rapamycin complex 1 (mTORC1) signalling in chondrocytes and other cell types. This finding has significant implications for cellular functions including autophagy, protein synthesis, and potentially cellular viability. These results identify new therapeutic targets for this pathologic process in a wide spectrum of ER-stress disorders such as type 2 diabetes, Alzheimer disease, and tuberculosis,” explained Karen L. Posey, PhD, Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.

PSACH symptoms generally are recognized beginning at two years of age. Patients with PSACH have normal intelligence and cranio-facial features. PSACH is caused by mutations in the gene encoding the cartilage oligomeric matrix protein (COMP). ER stress occurs when abnormal (unfolded or misfolded) COMP (MT-COMP) accumulates in the rough endoplasmic reticulum of chondrocytes. Rough ER, the portion of ER displaying ribosomes, is the network of membranous tubules within cells associated with protein and lipid synthesis and export.

In previous studies, Dr. Posey and her colleagues have investigated chondrocyte pathology in the growth plates of dwarf mice that express MT-COMP, in cultured rat chondrosarcoma (RCS) cells that express human MT-COMP, as well as in cultured cartilage nodules from PSACH patients. The mice replicate many of the clinical features and chondrocyte pathology reported in patients with PSACH.

In the current study, the researchers showed increased levels of MID1 protein in chondrocytes from the mutant dwarf mice as well as in cells from human PSACH patients. They also found that ER-stress-inducing drugs increased MID1 signalling, although oxidative stress did not.

The up-regulation of MID1 was associated with increased mTORC1 signalling in the growth plates of the dwarf mice. Rapamycin decreased intracellular retention of MT-COMP and decreased mTORC1 signaling. The mTOR pathway is activated during various cellular processes (eg, tumor formation and angiogenesis, insulin resistance, adipogenesis, and T-lymphocyte activation) and is dysregulated in diseases such as cancer and type 2 diabetes.

The results of this work show that MID1, mTORC1 signalling, the microtubule network, protein synthesis, inflammation, and autophagy form a complex multifaceted response to protein accumulation in the ER when clearance efforts fail and MID1 may act as a pro-survival factor.
EurekAlertwww.eurekalert.org/pub_releases/2018-12/e-iuo121018.php

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