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NIH Consortium Takes Aim at Vascular Disease-linked Cognitive Impairment and Dementia

To better predict, study, and diagnose small vessel disease in the brain and its role in vascular contributions to cognitive impairment and dementia (VCID), the National Institutes of Health has launched MarkVCID, a consortium designed to accelerate the development of new and existing biomarkers for small vessel VCID.

The five-year program, developed by the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), in collaboration with the National Institute on Aging (NIA), consists of seven research groups across the United States working together via a coordinating center based at Massachusetts General Hospital, Boston. A kick-off meeting for the consortium was held immediately prior to the International Stroke Conference 2017 in Houston, Feb. 20-21.

International Team Launches Community Competition to Understand Tumor Origins and Evolution

An international consortium of groups from Canada, the United States and the United Kingdom have come together to create an innovative, cloud-based, public challenge running on the Google Cloud Platform to optimize the discovery of genetically distinct groups of cells within cancers that could respond differently to treatment and have different risk of spreading. The ICGC-TCGA DREAM Somatic Mutation Calling Heterogeneity (SMC-Het) Challenge is the first project in the world to marry crowd-sourced benchmarking and cloud-based execution of DNA sequencing analysis pipelines to improve our understanding of tumour DNA. The Challenge launched on November 16, 2015 and will run until May 2016. Sign up to participate at: https://www.synapse.org/SMCHet.

COPD Biomarker Qualification Consortium Making Strides with Plasma Fibrinogen as New Biomarker

The COPD Biomarkers Qualification Consortium (CBQC) recently announced at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.

Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline, notes, “To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S. This is a major milestone for the CBQC, and it highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines for patients who need them.”

To support the submission, the CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.

A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an outcome for clinical trials. Fibrinogen, a protein that can be measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients (a COPD subtype).

Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, adds, “COPD is extremely heterogeneous. This complicates development of new treatments, as individual COPD patients may respond differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem. Specifically, fibrinogen measurement can help identify COPD patients at risk for death or hospitalization, which can allow individuals to participate in studies of novel treatments designed to improve those outcomes.”

The CBQC, organized under the auspices of the COPD Foundation, is a public-private partnership among academic researchers, pharmaceutical companies and government parties and agencies.

John W. Walsh, president and co-founder, COPD Foundation, states, “The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”

The CBQC Fibrinogen Working Group is composed of the following members:

  • Bruce Miller, industry co-chair, GlaxoSmithKline
  • Ruth Tal-Singer, GlaxoSmithKline
  • Mike Lowings, GlaxoSmithKline
  • Ubaldo Martin, AstraZeneca
  • Jeff Snyder, Boehringer-Ingelheim
  • Kay Tetzlaff, Boehringer-Ingelheim
  • Armin Furtwaengler, Boehringer-Ingelheim
  • Nicholas Locantore, GlaxoSmithKline
  • Nancy Leidy, Evidera
  • Amber Martin, Evidera
  • Jason Simeone, Evidera
  • David Mannino, academic co-chair, University of Kentucky
  • Stephen Rennard, University of Nebraska
  • David Lomas, University College London, U.K.
  • Jorgen Vestbo, University of Southern Denmark, University Hospital Manchester, U.K.
  • Graham Barr, Columbia University
  • Debora Merrill, COPD Foundation

Source: COPD Foundation

VolitionRx-led Consortium Awarded €780 000 ($1M approx.) Eurostars Grant

VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, is lead partner of a consortium in a project valued at €779,493 (approx. US$1M) under the EUREKA Eurostars scheme. The project aims to develop new applications of the Nucleosomics biomarker technology in inflammatory disease. The research will build on VolitionRx’s ongoing cancer diagnostic research program.

VolitionRx’s contribution to the project is to develop novel NuQ® biomarkers for immune response. VolitionRx will use its proprietary Nucleosomics® platform for biomarker development exploiting UK-based Alcyomics’ proprietary ex-vivo SkimmuneTM model.

The Eurostars Programme is a European innovation program managed by EUREKA. It is the first program dedicated to supporting research-based small- and medium-sized companies (SMEs) from across Europe. To be eligible for the grant, companies must form a consortium of at least two companies from different European countries, with the aim of developing a civilian-purposed new product, process or service.

“The Eurostars scheme is a prestigious European program designed to support SMEs like VolitionRx, and to encourage cross-border research and development collaboration,” says Mark Eccleston, VolitionRx’s External Collaborations Manager. “We are looking forward to working with our partners to develop novel applications for our Nucleosomics technology, while complementing our ongoing research in cancer diagnostics.”

Under the grant, VolitionRx will be reimbursed with 80% of the costs associated with its share of the joint project – €420,000 ($0.56M approx.) over two years.

Source: VolitionRx Limited

Syapse Joins Free the Data! Initiative and Provides Software to Power Participant-centric Hereditary Gene Mutation Database

Syapse, the leader in software for bringing omics into routine medical use, announced that it has joined the Free the Data! initiative. This consortium of policy makers, advocacy organizations, individuals, academic centers, and industry aims to fill the public information gap caused by the lack of available genetic information for the BRCA1 and BRCA2 genes, and plans to expand to provide other types of genetic information in an open, searchable database.

Syapse will provide the software infrastructure for the Free the Data! initiative, enabling powerful data mining, visualization, and reporting. Participants will be able to visualize their own variations and clinical data in comparison to those already in the database, while clinicians will be able to utilize variant interpretation in medical interactions. Researchers, industry, and others can utilize Syapse data mining tools to interrogate the variants, interpretation, and evidence, along with clinical data submitted by participants. Participants will have full control over data sharing and privacy preferences of the data they contribute. The campaign shares all variants with ClinVar, the National Institutes of Health public database, unless the participant dictates otherwise.

“Despite national attention on the patentability of human genes, a ruling against gene patentability doesn’t immediately provide broad access to BRCA1 and BRCA2 variants or place them in a public database that will allow for better diagnosis and care,” said Sharon F. Terry, M.A., president and CEO of Genetic Alliance. “Syapse provides the best platform for integrating complex genomics and clinical data from disparate sources, and reporting it in a dynamic and relevant interface to participants and clinicians. We are excited to be using Syapse software to enable all individuals to access genetic mutations and their clinical interpretations in order to improve care.”

“Syapse is pleased to join Genetic Alliance, University of California San Francisco (UCSF), InVitae Corporation, and advocates in the Free the Data! initiative to crowdsource the interpretation of BRCA1 and BRCA2 variants,” said Jonathan Hirsch, Founder & President of Syapse. “Syapse is committed to the free and open interpretation of the genome, but interpreting the genome requires a larger evidence base than any one entity can develop. Pooling genetic and clinical data will rapidly advance medical knowledge of clinically relevant genetic mutations, leading to more effective diagnosis, treatment, and cures.”

Individuals who have received genetic testing and who are interested in participating are invited to go to the Free The Data! project web site at www.free-the-data.org, and follow the instructions to upload test results, set privacy and sharing settings, and answer a brief questionnaire.

Individuals may also send a scan or PDF of the test report form with the personal identifying information blocked to Genetic Alliance by email at freethedata@geneticalliance.org or by facsimile at 202.966.8553.

We encourage individuals, advocacy groups, research organizations, physicians, policy groups, professional societies and industry to join the cause. For more information, please visit free-the-data.org or contact: 202.966.5557 x201.

Source: Synapse