Beckman Coulter Diagnostics is embarking on an innovation collaboration with Johns Hopkins Medicine to explore co-innovation initiatives with the goal of developing and commercializing novel solutions that address challenges in healthcare.
For over a century, Johns Hopkins has enhanced research outcomes and advanced scholarship through the rigorous application of innovative methodologies and research approaches. For Beckman Coulter Diagnostics, this is an opportunity to learn from some of the best clinical minds in real-time and in a real-world setting.
Through this collaboration, Beckman Coulter will benefit from observing Johns Hopkins’ researchers and clinicians as they work to develop new technologies and concepts, which represent medical breakthroughs that can potentially help patients. Moreover, they will be able to test solutions on-site with experts who are working toward better patient care. Eventually, these solutions may be brought to market and could contribute to elevating healthcare.
“This collaboration allows us to define and solve problems with experts across clinical fields and situations, and allows us to work alongside top-notch researchers to develop smart solutions,” said John Blackwood, senior vice president and general manager of products and services, Beckman Coulter Diagnostics. “It is critical to explore and test new and innovative solutions with clinicians working in actual clinical settings to determine real-world quality and effectiveness. This will help us to address clinical challenges in a rapidly changing environment and foster our efforts to move healthcare forward for every person.”
www.beckman.comwww.jhu.edu               

• Siemens Healthineers and Primary Health Care team up to revolutionize healthcare outcomes in pathology.
• The innovative Atellica® portfolio was integral in Primary’s decision to convert its laboratory instruments.

Integrated healthcare provider Primary Health Care has joined forces with Siemens Healthineers to deploy more than 70 Atellica® Solution1 immunoassay and clinical chemistry analyzers. This marks Siemens Healthineers largest contract for in vitro diagnostics testing in Australia, and one of its most robust sales of the Atellica Solution. The analyzers are integrated with Atellica Diagnostics IT solutions and will connect to the company’s strategic partner Inpeco’s FlexLab track for total lab automation to deliver a high throughput multidisciplinary solution with capabilities that are transforming the clinical laboratory landscape across the country.

The strategic engagement couples Primary’s expansive network of more than 2,300 national pathology collection sites with workflow improvement and expanded clinical capabilities from Siemens Healthineers to establish a new level of automated diagnostic delivery. Through deep analytics, and intelligent data and process management, Atellica Diagnostics IT software will provide Primary with improved visibility, flexibility and control over its entire operation.   

“This new collaboration will allow us to take Primary’s operational efficiencies to new heights,” said Wes Lawrence, Chief Executive of Pathology at Primary Health Care. “Thanks to this next-generation technology, we’re able to increase productivity, and focus more on value-adding lab activities and less on sample and instrument handling. In doing so, processes will be reduced and testing quality will be advanced, ultimately helping us increase cost savings and focus on the human impact of our work.”

Siemens Healthineers and Inpeco SA will deliver this fully automated multidisciplinary solution that will vastly simplify clinical and operational workflows and help Primary achieve better outcomes at much lower costs.

“Healthcare systems are constantly under pressure to drive efficiency, and to improve both clinical and business outcomes, said Deepak Nath, Ph.D., President, Laboratory Diagnostics Siemens Healthineers. “At Siemens Healthineers we’ve designed and built innovations that enable our customers to optimize processes and add value for laboratory staff and their healthcare facilities.”

Sebastian D’Angelo, General Manager, Laboratory Diagnostics, Australia, Siemens Healthineers added, “With the introduction of the Atellica Solution and the complementary, innovative offering of Atellica Diagnostics IT, we’ll turn what has been more than a decade of collaboration with Primary Health Care into an entirely new frontier for the Australian pathology industry.”

Primary Health Care has a large presence in all mainland states. One in every three pathology samples taken in Australia is tested in a Primary laboratory. The Siemens Healthineers technology will be rolled out in New South Wales, Queensland, Victoria and Western Australia. The scale of deployment through this opportunity will cement Siemens Healthineers as a market leader within the Australian pathology industry.

For more information about the Atellica Solution, visit https://www.healthcare.siemens.com/integrated-chemistry/systems/atellica-solution-analyzers

The largest study of its kind, led by international researchers including scientists at RCSI (Royal College of Surgeons in Ireland), has discovered 11 new genes associated with epilepsy.
The research is published in today’s issue of Nature Communications (DOI: 10.1038/s41467-018-07524-z). It greatly advances knowledge of the underlying biological causes of epilepsy and may inform the development of new treatments for the condition.
Researchers compared the DNA of more than 15,000 people with epilepsy to the DNA of 30,000 people without epilepsy. This has created a better understanding of genetic factors that contribute to the most common forms of this condition, and the results tripled the number of known genetic associations for epilepsy and implicated 11 new genes.
The researchers found that the majority of current anti-epileptic drugs directly target one or more of the associated genes and identified an additional 166 drugs that do the same. These drugs are promising new candidates for epilepsy therapy as they directly target the genetic basis of the disease.
“This work illustrates the power of scientists collaborating across countries and continents. Discovering these new genes for epilepsy provides important information towards novel treatments for the condition. This is another important step on the road towards curing the epilepsies,” said Gianpiero Cavalleri, Associate Professor at the RCSI Department of Molecular and Cellular Therapeutics and Deputy Director of the FutureNeuro SFI Research Centre.
"In addition to the biological insights provided by the findings, this study will encourage researchers to develop personalised and precision therapies for patients with difficult and complex epilepsy. This will provide better seizure control and will enable improved quality of life for patients and families," said consultant neurologist Norman Delanty, Associate Professor at RCSI, FutureNeuro and Beaumont Hospital.
“We have appreciated for some time that genetics plays an important role in epilepsy, however, until now, relatively little was known about the specific genes responsible for the most common forms of the disorder.  Identifying the genes that cause epilepsy is particularly important when we consider that a third of the 65 million patients worldwide will not become seizure free using current treatment options,” said Dr Colin Doherty, National Clinical Lead for Epilepsy and a Principal Investigator at the FutureNeuro Centre.
Over 150 researchers, based across Europe, Australia, Asia, South America and North America, carried out the research.  They worked together as part of the International League Against Epilepsy (ILAE) Consortium on Complex Epilepsies. The ILAE Consortium was formed by researchers in 2010, recognising that the complexity of genetic and environmental factors underlying epilepsy would require research across massive datasets, and therefore unprecedented collaboration on an international scale. Science Foundation Ireland (SFI) part-funded the study.
“Conducting a study of this size and scope is an incredible accomplishment that RCSI and FutureNeuro were delighted to help lead.  We look forward to building on the results of this study and strengthening international collaborations,” said Professor Cavalleri.
“The next steps would be expanding these results in an even larger sample, which is underway, and then drilling down on specific groups of patients and the genes that influence their type of epilepsy to trial new therapies,” Professor Sam Berkovic, University of Melbourne.

https://www.rcsi.com/dublin/https://www.ilae.org/

ISCT, the International Society for Cell and Gene Therapy, the global professional society of clinicians, researchers, regulatory specialists, technologists and industry partners in the cell and gene therapy sector, announced on November 20, 2018 the first publication of its new annual report detailing global cell and gene therapies (CGT) with market authorization.
The CGT market authorization report is intended to provide a centralized resource and increased clarity for all of those involved in the CGT industry. This involves the scientific community, healthcare stakeholders and patient associations. The report will be a regularly updated document that will be republished yearly, and accessible through the ISCT website.
The report has been designed to react to the increase in momentum around a widening number of CGT authorizations, as well as a parallel increase of unproven approaches where cells are delivered as treatments without rigorous scientific and regulatory assessment and authorization.
The report has been prepared by select members of the ISCT Presidential Task Force (PTF) on the Use of Unproven and/or Unethical Cell & Gene Therapies (UCGT) with lead authors Natividad Cuende (Executive Director, Andalusian Initiative for Advanced Therapies, Seville, Spain) and Laertis Ikonomou (Assistant Professor of Medicine, Boston University School of Medicine, Boston, MA). The ISCT Presidential Task Force was formed in 2014 to support ISCT’s ongoing commitment to address the rise of commercially available unproven or insufficiently proven CGT treatments. These approaches are targeted at hopeful individuals seeking cures or health improvement for a variety of conditions. The PTF-UCGT characterizes unproven cellular interventions and promotes safe and effective practices worldwide.
The reliable, up-to-date resource will help patients to make informed decisions before receiving a CGT treatment so that they can avoid being exposed to unproven and unlicensed cell interventions not approved by a regulatory or medicine agency.
The report also provides an annual breakdown of CGTs that have received, as well in some cases, have withdrawn, market approval. This includes analysis on types of product and therapy as well as disease targeted. 44 unique products were identified. 84% were cell and tissue therapies, and 55% were autologous. More than one third target oncological or hematologic conditions.
In the US, there are over 16 cell, tissue and gene products with marketing authorization, 14 in Korea, eight in Europe, four in India and Japan, two in Canada, and one each in China and Australia. This contrasts with Russia, Middle East, Africa, Central and South America, which have no CGT market authorizations or data available.
“The number of market approved cell and gene therapy treatments continues to grow, with a high number of other therapies seeking approval. It is critical for all those involved in the sector, and most importantly those patients that may benefit from newly approved treatments, to have an annually updated resource detailing all approved cell and gene therapies,” said Massimo Dominici, Chair of the ISCT Presidential Task Force on Unproven and Unethical Cell & Gene Therapies. “This resource will give patients visibility on what cell and gene therapies have gone through proper approval processes, and help them alongside physicians to make more informed decisions about their treatment.”
In tandem with the efforts of professional societies like ISCT, it is imperative that the regulatory environment and guidance keep pace with the rapid advancements in cell and gene therapy. As such, this report also supports ISCT the FDA’s continued publication of numerous draft CGT guidance documents in 2018.

www.celltherapysociety.orgwww.isct-unprovencellulartherapies.org

Data-driven food allergy diagnostics company, AllerGenis, LLC announced on January 16 that it has entered into a non-exclusive agreement with Luminex Corporation (NASDAQ: LMNX). According to the terms, AllerGenis will have the rights to develop, market and sell its novel precision food allergy diagnostic assay using Luminex’s xMAP® Technology.
The agreement supports the upcoming 2019 commercialization of AllerGenis’ food allergy diagnostic platform, which more than triples diagnostic precision compared to current food allergy tests. AllerGenis’ high-throughput, peptide-bead assay breaks down allergenic proteins into smaller components, called epitopes. It then measures the reactivity of a patient’s antibodies to each epitope to generate a detailed reactivity profile that can provide clinicians a comprehensive solution with accurate information to better assess and manage that patient’s food allergies.
“Adopting Luminex’s bead-based xMAP® technology dramatically increased the power and scope of our food allergy diagnostic,” said Jim Garner, CEO and board member of AllerGenis. “We have been able to scientifically demonstrate the ability to identify food allergies with much higher precision over currently available blood tests. We’re very excited to enter into this agreement with Luminex to bring this much-needed technology to the clinical setting as soon as possible.”
AllerGenis’ peanut allergy assay will be the first product to launch supported by this agreement in the fall of 2019. The company is also developing a pipeline of assays across a wide range of food allergens using its epitope-based technology, as well as novel biomarkers.

http://www.allergenis.com/