ZIKA - WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain-Barré syndrome
An Emergency Community was convened under the International Health Regulations to determine and advise on the severity of the Zika virus health threat. Eighteen experts and advisers agreed that the causal relations between the Zika infection during pregnancy and microcephaly is strongly suspected, though not yet scientifically proven. Consideration and discussion regarding the spread patterns and geographic distribution of the mosquito species were reviewed. It was noted that the lack of vaccines and rapid and reliable diagnostic tests, in addition to the absence of population immunity were cited as cause for concern. "After a review of the evidence, the Committee advised that the recent cluster of microcephaly cases and other neurological disorders reported in Brazil, following a similar cluster in French Polynesia in 2014, constitutes an “extraordinary event” and a public health threat to other parts of the world."
Related Article: Sperm banks draft Zika virus policy
Related Map: CDC Areas with Zika Map
Related Article: Zika virus pregnancy case confirmed in Spain - first in Europe
Abbott to Acquire Alere, a Maker of Medical Diagnostics Tests - The New York Times
In a $5.8 billion exchange, Abbott will be acquiring Alere, a Massachusettes based company that produces point-of-care medical tests. Alere was founded in 2001 and delivered more than 1.4 billion tests last year alone, resulting in annual sales of $2.5 billion. Their tests include HIV, tuberculosis, malaria, dengue, flu and strep. As only 10% of Abbott’s tests include point-of-care, the current merger will expand their reach in this market. However, Alere's net debt of $2.6 billion will be assumed or refinanced by Abbott. This deal is highly strategic and timely, considering the spread of deadly viruses such as Zika that are spreading across the globe and putting the spotlight on diagnostic test makers and vaccine developers.
Press Release: Abbott to Acquire Alere, Becoming Leader in Point of Care Testing and Significantly Advancing Global Diagnostics Presence
Related Article: Abbott Labs to buy diagnostics company Alere for $5.8 billion
Federal regulators say a Theranos lab has serious problems
Theranos has received a letter from federal regulators citing that the company’s California laboratory has serious deficiencies which place patients in immediate jeopardy (5 violations valued at $10,000 per day the infractions occur past deadline). The majority of Theranos testing (90%) goes to the Arizona lab which was not a part of the audit. The company only received inspector approved certification to test blood in California under specific conditions. A response by Theranos within 10 days is required unless they are willing to accept paying large fines or closure. The brief descriptions of the violations included:
- Analytic systems
- Laboratories performing high complexity testing; laboratory director
- Laboratories performing high complexity testing; technical supervisor
- Laboratories performing high complexity testing; testing personnel
This means that the lab had problems relating to its blood analyzers and the way it studies blood cells. Also, it states that the laboratory was mismanaged from the Director level down to the bench staff. Theranos has taken some action already to replace specific employees.
Related Article: Here’s what Theranos customers need to know
New handheld, pen-sized microscope could ID cancer cells in doctor’s offices and operating rooms | UW Today
Finding the balance between removing malignant tumour cells and maintaining as much healthy tissue as possible, is a difficult art form. The University of Washington, Memorial Sloan Kettering Cancer Center, Stanford University and the Barrow Neurological Institute have collaboratively developed a miniature microscope that could allow surgeons to “see” at a cellular level while conducting an operation. Ultimately, this microscope is redefining the accuracy of the tissue removal process for the betterment of patient related outcomes. The results of this have been published in the journal Biomedical Optics Express. The handheld microscope is approximately the size of a pen, which is much smaller than current devices on the market. It utilizes technologies in a novel way to deliver high-quality images at faster speeds than existing devices. Researchers expect to begin testing it as a cancer-screening tool in clinical settings next year.
Schizophrenia’s strongest known genetic risk deconstructed
Quote: “This study marks a crucial turning point in the fight against mental illness… Thanks to this genetic breakthrough, we can finally see the potential for clinical tests, early detection, new treatments and even prevention.” states Bruce Cuthbert, acting director of the National Institute of Mental Health.
Schizophrenia is one of the most common serious mental health conditions in the world. The cause of this disorder has been evasive due to scientist’s inability to replicate it in living cells or animals. For the first time, researchers have identified the specific gene variant which over activates the synaptic pruning process and increases the likelihood of developing schizophrenia. Using genetic analysis of almost 100,000 DNA samples from 30 countries, postpartum brain samples from almost 700 patients, and animal models, it was identified that the complement component 4 (C4) with higher expression also had higher amounts of pruning. In the brain, “C4 binds to neurons at the points where they connect with other neurons, and signals that these connections, or synapses, should also be engulfed by immune cells,” as discussed by Clare Wilson. Schizophrenics tended to have fewer connections between neurons providing further evidence of C4’s innate connection.
Published Article: Schizophrenia risk from complex variation of complement component 4
Related Article: Rethinking schizophrenia: Taming demons without drugs
Subscribe to sequencing technology study supports use of sequencing in clinical cytogenetics, pathogenic CNV detection
Published in Genetics in Medicine, researchers from BGI-Shenzhen, The Chinese University of Hong Kong, Nanjing Medical University, and other colleagues, concluded that low-coverage whole-genome sequencing may be a feasible alternative to chromosomal microarray analyses when searching for clinically relevant copy number variations. Using low-pass genome sequencing on samples from hundreds of prenatal and postnatal samples referred for chromosomal analyses, producing informative profiles for more than 96 percent of the samples. The team's search led to 119 chromosomal abnormalities, along with 103 copy number gains or losses. The diagnostic yield differed depending on the source of the samples, peaking at more than 53 percent in the 198 miscarried fetuses considered and dropping to as low as 14.7 percent across the stillborn samples. Based on these and other findings, the study's authors contended that the work "highlights the potential for using [next-generation sequencing] to facilitate genetic diagnoses in the prenatal and postnatal samples that have not been detected by conventional karyotyping and/or [chromosomal microarray] analysis."
Good Start Genetics’ Cost Effectiveness Study Demonstrates Clinical Outcomes and Healthcare Cost Advantages
The Good Start Genetics company announced their publication in Molecular Genetics & Genomic Medicine suggesting that carrier screening utilizing the company’s next-generation sequencing (NGS) leads to better health outcomes in addition to being a cost-effective screening strategy. It was found that decreases in lifetime treatment costs using the NGS could be as high as 66 percent when compared to no screening, and 12 percent when compared to traditional genotyping-based carrier screens. Also described is a robust and comprehensive decision tree model of 1 million couples representative of the United States population. Data from published literature, population surveys, and expert opinion were used to capture and reflect a complex network of medical decisions and outcomes related to carrier screening and reproductive health. The model took into account direct medical costs such as screening, diagnosis and treatment costs associated with three broad health outcomes.
British researchers get green light to genetically modify human embryos
The Human Fertilisation and Embryology Authority (HFEA) in Britain has approved a license application to perform genome editing on human embryos. The application was made by Kathy Niakan, a stem cell scientist at the Francis Crick Institute in London. Over a 14 day study period, embryos donated by couples with a surplus after IVF treatment, will be examined during the fertilized egg’s development - from a single cell to about 250 cells (no implantation into women). The basic research will use a genome editing procedure called Crispr-Cas9 to switch on and off genes. The collected information may help scientists understand why some women lose their babies before term and provide better clinical treatments for infertility, using conventional medical methods. This work comes only months after Chinese researchers became the only team in the world to announce they had altered the DNA of human embryos.
Related Article: UK scientists seek permission to genetically modify human embryos
Related Article: Scientists genetically modify human embryos in controversial world first
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