DiaSys signs cooperation agreement with Tosoh Bioscience

DiaSys Diagnostic Systems GmbH has established a future-oriented cooperation with Tosoh Bioscience. The aim of this cooperation is to consolidate clinical chemistry (DiaSys BioMajesty® JCA-BM6010/C), immunoassays (Tosoh AIA-CL® 1200), hematology and coagulation analysis either simply with a middleware (EVOLINE® Manager; TOSOH) or fully automated with a track system. The conveyor system (EVOLINE®; Tosoh) offers the option to combine the DiaSys clinical chemistry analyser BioMajesty® JCA-BM6010/C with a wide range of analysers from different vendors. This partnership addresses the common trend of consolidation which aims to provide tailor-made solutions for individual customer needs.   www.diasys-diagnostics.com

Thermo Fisher Scientific offers preview of the world’s first fully integrated LC-MS/MS Clinical Analyser

Following the presentation to the European market at EuroMedLab in Athens and to the US market at AACC 2017 of the Thermo Scientific Cascadion SM Clinical Analyser bringing together the ease of use of clinical analysers with the selectivity and sensitivity of liquid chromatography-tandem mass spectrometry (LC-MS/MS), the company will now seek CE marking  followed by FDA approval.
“This is a marvelous development, and it is really quite outstanding. It will fulfill the needs of many laboratories,” said Professor Brian Keevil, consultant clinical scientist and head of the Clinical Biochemistry Department, University Hospital of South Manchester NHS Foundation Trust, UK, after viewing a demonstration during EuroMedLab 2017.
The Cascadion system was designed and built using Thermo Fisher products and technologies combined with its industry-leading expertise in mass spectrometry.  Featuring turnkey operation, the Cascadion analyser is designed to be used by laboratory staff with no specialized training.
James Nichols, PhD, medical director, Chemistry and Point of Care Testing, Vanderbilt University Medical Center, added, “For much of what we do in terms of chromatography and mass spectrometry, we need very highly skilled and experienced medical technologists. The Cascadion analyser is relatively maintenance-free and because it includes specially designed reagent kits, there is not a lot of interaction required with the technology.”
After previewing the Cascadion analyser, Michael Vogeser, senior physician and professor of laboratory medicine, University Hospital of Munich, stated “About 70% of all physician’s decisions are based on laboratory tests so the impact on laboratory testing is huge and this completely new technological approach is of enormous value to mankind.” www.thermofisher.com/Cascadion

DIAsource ImmunoAssays acquires Viro-Immun Diagnostics

DIAsource ImmunoAssays® SA, the Belgian-based company specializing in development, sales and distribution of clinical diagnostics products, acquired the full assets of Viro-Immun Diagnostics GmbH, the German company specialized for 30 years in the development and manufacture of laboratory diagnostics for medical diagnosis of infectious (viral, bacterial, parasitic and candidiasis) and autoimmune diseases.
This transaction allows DIAsource to strengthen and extend its established portfolio of proven best-in-class endocrinology and Vitamin D products with a wide panel of high quality ELISA (Borrelia, Chlamydia, Mycoplasma, Influenza, Candida, …) and Immunofluorescence assays (IFA), known as the gold standard for diagnosing autoimmune disorders. www.diasource-diagnostics.com

HORIBA Medical and Siemens Healthineers enter into agreement to expand laboratory hematology offerings

HORIBA Medical and Siemens Healthineers have entered into a long-term agreement. The companies will collaborate in bringing new and innovative hematology solutions to the market globally. With HORIBA Medical as the original equipment manufacturer to complement the Siemens Healthineers portfolio, the companies will provide customers with expanded options to fulfill their hematology and multidisciplinary solution needs.

“With our commercial strength and global installed base of customers combined with HORIBA Medical’s innovative technologies, the relationship will expand the hematology solutions available to laboratories for diagnostics testing worldwide,” said Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers.

“Our long-term vision and continuous investments coupled with our outstanding employees have resulted in innovative hematology technology solutions. I am extremely pleased that this long-term vision has resulted in an alliance with Siemens Healthineers” said Mr. Atsushi Horiba, Chairman, President & CEO of HORIBA, Ltd.

www.horiba.com/medicalwww.siemens.com/healthineers

Link between bacterial imbalances and breast cancer

In a newly published study, Cleveland Clinic researchers have uncovered differences in the bacterial composition of breast tissue of healthy women vs. women with breast cancer. The research team has discovered for the first time that healthy breast tissue contains more of the bacterial species Methylobacterium, a finding which could offer a new perspective in the battle against breast cancer.
Bacteria that live in the body, known as the microbiome, influence many diseases.
Most research has been done on the “gut” microbiome, or bacteria in the digestive tract. Researchers have long suspected that a “microbiome” exists within breast tissue and plays a role in breast cancer but it has not yet been characterized. The research team has taken the first step toward understanding the composition of the bacteria in breast cancer by uncovering distinct microbial differences in healthy and cancerous breast tissue.
“To my knowledge, this is the first study to examine both breast tissue and distant sites of the body for bacterial differences in breast cancer,” said co-senior author Charis Eng, M.D., Ph.D., chair of Cleveland Clinic’s Genomic Medicine Institute and director of the Center for Personalized Genetic Healthcare. “Our hope is to find a biomarker that would help us diagnose breast cancer quickly and easily.  In our wildest dreams, we hope we can use microbiomics right before breast cancer forms and then prevent cancer with probiotics or antibiotics.”
The study examined the tissues of 78 patients who underwent mastectomy for invasive carcinoma or elective cosmetic breast surgery. In addition, they examined oral rinse and urine to determine the bacterial composition of these distant sites in the body.
In addition to the Methylobacterium finding, the team discovered that cancer patients’ urine samples had increased levels of gram-positive bacteria, including Staphylococcus and Actinomyces. Further studies are needed to determine the role these organisms may play in breast cancer.
Co-senior author Stephen Grobymer, M.D., said, “If we can target specific pro-cancer bacteria, we may be able to make the environment less hospitable to cancer and enhance existing treatments. Larger studies are needed but this work is a solid first step in better understanding the significant role of bacterial imbalances in breast cancer.” Dr. Grobmyer is section head of Surgical Oncology and director of Breast Services at Cleveland Clinic.

Cleveland Clinic
newsroom.clevelandclinic.org/2017/10/05/cleveland-clinic-researchers-find-link-between-bacterial-imbalances-and-breast-cancer/

Preeclampsia triggered by an overdose of gene activity

Preeclampsia is the most dangerous form of hypertension during a pregnancy and can be fatal for both mother and child. Though it is known to originate in the placenta, the root causes remain largely a mystery. An international research team led by the Max Delbrück Center for Molecular Medicine (MDC) has recently published new findings which reveal that preeclampsia is not in fact a single disease caused solely by genetic factors. Their tests on placenta samples have shown that epigenetically regulated genes play an important role. The Berlin research team also developed an in vitro model of the disorder which demonstrates the dysregulation of an important transcription factor.
The research team compared placental tissue samples and the genetic makeup of patients with preeclampsia with those of healthy women. The entirety of their genetic material was analysed for genes that are differentially expressed in the preeclamptic versus healthy placentas and checked for disrupted genomic imprinting, which refers to certain genes that are “switched off” on either the paternal or maternal chromosome. This led them to identify the so-called DLX5 gene as a significant transcription factor involved in regulating the activity of other genes in preeclampsia. This gene is usually turned off – or epigenetically “imprinted” – on the paternal chromosome, controlling the proper dosage of gene expression. Due to loss of the regulation by imprinting, DLX5 was strongly upregulated in ca. 70 percent of the samples studied from preeclampsia patients, meaning the gene was switched on in these cases. This study is the first to demonstrate that a change in epigenetic gene regulation by imprinting can contribute to preeclampsia. The scientists also found three separate types of preeclampsia, supporting the view that preeclampsia is a complex disease.

Max Delbrück Center for Molecular Medicine
insights.mdc-berlin.de/en/2017/10/preeclampsia-triggered-overdose-gene-activity/
 

Genetic drivers of most common form of Lymphoma identified

Lymphoma is the most common blood cancer, but the diagnosis belies a wildly diverse and little understood genetic foundation for the disease that hampers successful treatment.
An international research effort led by Duke Cancer Institute scientists has been working to better understand the genetic underpinnings of the most prevalent form of this cancer — diffuse large B cell lymphoma – and how those genes might play a role in patients’ responses to therapies.
The researchers analysed tumour samples from 1,001 patients who had been diagnosed with diffuse large B cell lymphoma over the past decade. These patients had been treated at 12 institutions around the world.
Using whole exome sequencing, the researchers pinpointed 150 genetic drivers of the disease, many newly identified. The team then tested to see if there were any correlations between the genes and how well patients had responded to standard therapies. The team applied a genome editing technique known as CRISPR to knock out each of the 20,000 genes in lymphoma cells to identify those that are critical for lymphoma cells to grow. By assessing the genetic, CRISPR and clinical results, the researchers found several critical genetic links that could help guide treatments.
“This work provides a comprehensive road map in terms of research and clinical priorities,” said Sandeep Davé, MD, professor of medicine at Duke. “We have very good data now to pursue new and existing therapies that might target the genetic mutations we identified. Additionally, this data could also be used to develop genetic markers that steer patients to therapies that would be most effective.”

Duke Cancer Institute
www.dukecancerinstitute.org/news/researchers-identify-genetic-drivers-most-common-form-lymphoma

Candidate genetic factor for the effects of prenatal alcohol exposure has been found

Researchers at the University of Helsinki have found a genetic variation, which associates with the damage caused by maternal alcohol consumption. This genetic variation clarifies the role of genetic factors in the alcohol-induced developmental disorders and could be useful in future diagnostics.
The effects of prenatal alcohol exposure (PAE) on placental genes involved in growth and on the size of affected newborns were explored in the study performed at the University of Helsinki and Helsinki University Hospital in Finland. The researchers observed that alcohol alters epigenetic marks on the placenta and also the head size of newborn, depending on the genetic variation inherited from the parents.
Epigenetic marks are molecules, which bind to DNA sequence. They regulate the activity of genes and thus production of proteins in the cells.
The research material was 39 alcohol-exposed and 100 control placentas. They were collected from mothers who gave birth in the Helsinki University Hospital and had given approval for their participation in the study.
It is already known that in addition to neuronal disorders and birth defects, alcohol causes retarded growth. Therefore the researchers focused on two genes, insulin-like growth hormone 2 (IGF2) and H19, which locate near each other and regulate the growth of the placenta and embryo.
There is a common genetic variation in the Finnish population in the DNA region which regulates the function of these genes. The genetic variants that an individual inherits from the parents have been shown to associate with the amount of epigenetic marks on this region. This led the researchers to examine this intensively studied genomic region in a novel way.
– We divided all our samples in four groups according to the inherited genetic variations. We observed that there were different quantities of epigenetic marks in the groups of alcohol-exposed placentas compared with controls, explains Adjunct Professor Nina Kaminen-Ahola, the leader of the research team at the University of Helsinki.
– This finding led us to explore if there are changes in the gene expression and newborns’ birth measurements that would associate with the variation. We observed that expression of the negative growth controller H19 was significantly increased compared to expression of the growth supporter IGF2 in certain variant groups of the alcohol-exposed placentas.
The birth measurements were analysed by using new Finnish growth charts. Previous studies have shown that alcohol particularly affects the head growth and thus head circumference has been used as a mark of alcohol-induced damage. However, this study indicated that the head circumferences of alcohol-exposed newborns vary significantly depending on the genetic variations inherited from parents.
– We do not know yet if this variation is connected with alcohol-induced neuronal disorders. However, this could explain earlier study results concerning decreased correlation between HCs and brain size, as well as between HCs and cognitive skills among alcohol-exposed children. This suggests that alcohol causes damage in the brain in all genotypes, but this cannot be always seen in the head size, Kaminen-Ahola states.

University of Helsinki
www.helsinki.fi/en/news/a-candidate-genetic-factor-for-the-effects-of-prenatal-alcohol-exposure-has-been-found

Gene that influences nicotine dependence identified

A DNA variant—located in the DNMT3B gene and commonly found in people of European and African descent—increases the likelihood of developing nicotine dependence, smoking heavily, and developing lung cancer, according to a new study led by RTI International.
Nearly 1 billion people smoke and 6 million premature deaths occur worldwide each year from cigarette smoking, according to the World Health Organization. Smoking is the leading cause of preventable death and one person dies approximately every 6 seconds from smoking-related causes, according to the WHO.
The new study is the largest genome-wide association study of nicotine dependence. Researchers studied more than 38,600 former and current smokers from the United States, Iceland, Finland, and the Netherlands.
“This new finding widens the scope of how genetic factors are known to influence nicotine dependence,” said Dana Hancock, Ph.D., genetic epidemiologist at RTI and lead author of the study. “The variant that we identified is common, occurring in 44 percent of Europeans or European Americans and 77 percent of African Americans, and it exerts important effects on gene regulation in human brain, specifically in the cerebellum, which has long been overlooked in the study of addiction.”
The genetic variant was linked to an increased risk of nicotine dependence by testing nearly 18 million variants across the genome for association with nicotine dependence. The variant was also tested in independent studies and found to associate with heavier smoking and with increased risk of lung cancer. 

RTI International
www.rti.org/news/researchers-identify-gene-influences-nicotine-dependence
 

Collaboration between Ortho Clinical Diagnostics and EKF Diagnostics

Ortho Clinical Diagnostics (Ortho) and EKF Diagnostics (EKF) recently announced an agreement that allows Ortho customers to access EKF’s Stanbio Chemistry Beta-Hydroxybutyrate (BHB) LiquiColor® assay. This is an important marker used in conjunction with clinical findings and other lab tests for the diagnosis and management of ketoacidosis and its main causative factor, diabetic ketoacidosis (DKA). The high-quality, fully automated assay is now available for use on Ortho’s VITROS® 4600 Chemistry System and the VITROS® 5600 Integrated System.

Diabetic ketoacidosis is a serious complication that can lead to a disruption of chemical balance in the body, and can be fatal if left undiagnosed. EKF’s enzymatic Beta-Hydroxybutyrate (BHB) assay is used primarily for determining both the presence and degree of ketosis in suspected diabetic ketoacidosis cases. The BHB assay produces a quantitative value that is specific to the BHB ‘ketone body’. These qualities make the BHB assay the new clinical diagnostic standard of care for ketone testing.

“Ortho is committed to delivering a broad menu of assays to our customers in the clinical lab, whether through in-house development or collaborations like the one with EKF,” said Ortho’s chief Operating Officer Robert Yates.

Ortho and EKF are collaborating to provide the BHB assay as a validated MicroTip Partnership Assay (MPA) application in the U.S. and Canada. This MPA utilizes the User Defined Assay (UDA) feature, which provides the capability to program assay parameters as defined in the EKF Stanbio Assay Application Sheet. The Beta-Hydroxybutyrate LiquiColor® assay has been CLIA classified by the U.S. Food and Drug Administration (FDA) as a MODERATE complexity assay on the VITROS® 4600 Chemistry System and VITROS® 5600 Integrated System.

“Diabetic ketoacidosis is a serious condition, and our collaboration with Ortho Clinical Diagnostics will help to deliver the important BHB assay to their existing customers” said EKF’s Diagnostics Head of Sales, Gilbert Mejia.

EKF Diagnostics’ Stanbio Chemistry portfolio is a broad range of liquid-stable reagents, calibrators, standards and controls. LiquiColor® and Liqui-UV® reagents are designed for maximum stability, ease-of-use and are optimized for today’s chemistry analyzers. In addition to its BHB test for ketosis, EKF continues to build on its successful range of esoteric reagents.

 

www.orthoclinicaldiagnostics.comwww.ekfdiagnostics.com