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Launch of a Transformative Health Care Initiative: The National Biomarker Development Alliance (NBDA)

The launch of a new independent, non-profit organization, the National Biomarker Development Alliance (NBDA), broadly engaging leaders in industry, academia, patient groups and government from across the country, was recently announced at the National Press Club by the Research Collaboratory at Arizona State University (ASU). The mission of the NBDA is to address the complex and urgent challenge of creating the standards needed to support end-to-end evidence-based biomarker development in order to significantly advance precision (personalized) health care.

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

Amplion Research Launches Version 2.0 of BiomarkerBase™, the Database of Clinical Biomarkers, Significantly Expanding Its Ability to Inform Investments in Molecular Biomarkers and Personalized Medicine

BiomarkerBase™ 2.0 now includes every validated biomarker in clinical use, along with a significantly improved user interface and expanded functionality. The team at Amplion Research, publishers of BiomarkerBase™, manually reviewed every IVD test cleared or approved by the FDA since 2000, adding to the extensive set of test, drug, and clinical trial data already included in the database.

“Being aware of all existing clinical applications for molecular biomarkers is an important part of the groundwork for biomarker development projects,” said Adam Carroll, Ph.D., Science Director at Amplion Research. “Our primary goal has always been to give our clients confidence that they have in front of them the complete set of validated clinical biomarkers. To achieve that goal, there is no substitute for manual curation of the data,” said Carroll. “Additionally, all of the linkages between biomarkers and the specific tests, drugs, and trials that define them were each individually reviewed, making BiomarkerBase™ a very robust reference tool.”

Data Enhancements

Along with every validated clinical biomarker, the database also includes every emerging clinical biomarker disclosed in a phase 3 or 4 clinical trial, and will soon include all phase 1 and 2 trials as well. BiomarkerBase™ also now includes publications in its dataset for the first time, and most biomarkers in the database include the total number of published clinical studies for each biomarker, with full publication details for the 10 most recent. Additional enhancements to published clinical data and data from other sources are already in progress.

Interface Enhancements

Biomarkers can now be browsed by target, disease, drug, company, or therapeutic area, and every IVD test, drug label, and clinical trial that includes the biomarker is listed, with direct links to the primary records at FDA and NIH. BiomarkerBase™ has a clean and intuitive interface that makes browsing biomarkers and their related information fast. The database is, at the same time, very well connected, both internally and externally, making it easy to follow the key links between different information types.

Stakeholders in biomarker projects at drug companies, diagnostics companies, contract research organizations, technology transfer offices, and investment firms are all using BiomarkerBase™ to stay on top of every clinical application for a molecular biomarker; every drug label that includes a biomarker; and every clinical trial that includes a disclosed biomarker.

Source: Business Wire

Deadly Effects of Certain Kinds of Household Air Pollution Lead to Call for Biomarker Studies

Almost four million people die each year from household air pollution (HAP) caused by exposure to the combustion of biomass fuels (wood, charcoal, crop residues, and dung), kerosene, or coal. These individuals are among the tens of millions who rely on such products to cook their meals, heat their rooms, and light their homes. Those in lower and middle income countries are among the hardest hit by the effects of HAP exposure, which also causes childhood respiratory infection, chronic lung disease, and cardiovascular disease. Exposure to biomass fuel is associated with low birth weight, asthma, and tuberculosis.

Given these effects, the large populations at risk, and a growing global interest in lower-cost energy sources, researchers from three continents have published a comprehensive overview of the current approaches to HAP assessments, the aims of biomarker development, and the state of development of tests which have the potential for rapid transition from the lab bench to field use. Their findings are addressed in the article, “Household air pollution: a call for studies into biomarkers of exposure and predictors of respiratory disease,” which is published online by the American Journal of Physiology-Lung Cellular and Molecular Physiology.

The effort is being led by William J. Martin II, MD, Associate Director for Disease Prevention and Health Promotion, Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health (NIH). The team is also comprised of Jamie Rylance, BM BS BMedSci MRCPTM&H, and Stephen Gordon, MA MD FRCP DTM&H, Professor and Chair in Respiratory Medicine, both from the Liverpool School of Tropical Medicine, Liverpool, United Kingdom; Luke P. Naeher, PhD and Olorunfemi Adetona, PhD, both from the University of Georgia, College of Public Health, Department of Environmental Health Sciences, Athens, Ga.; Archana Patel, IMD, DNB, MSCEs, Professor and Head of the Department of Pediatrics, Indira Gandhi Government Medical College, Nagpur, India; John R. Balmes, MD, Professor of Medicine, Division of Occupational and Environmental Medicine, University of California, San Francisco School of Medicine, San Francisco, Ca.; and Derek K. Rogalsky, Georgetown University School of Medicine, Washington, D.C.

Current approaches to HAP assessment, challenges

The researchers found that current HAP assessment tools include direct quantitative measurement of products of incomplete combustion, as well as qualitative methods (including use of questionnaires or the categorization of HAP exposure by type). However, direct exposure assessments via personal monitoring are problematic due to the size, portability and recording capacity of equipment, and acceptability to the user.

Despite the new devices currently being field tested and scaled up for commercial use to address these concerns, specific particulate measurement alone cannot differentiate between the multiple sources of pollution such as mixtures of HAP, tobacco smoke, and outdoor pollution. “The grand challenge to the research community is to produce simple and validated tests that better identify populations that are at risk from HAP, and individual responses to exposure reduction strategies,” according to Dr. Martin.

The researchers also found that current HAP exposure measurement methods are expensive, technically challenging, difficult to use with large population studies, and have substantial limitations, making an urgent case for the development of biomarkers of both exposure and health effects. These findings have led to their call for studies into biomarkers of exposure and predictors of respiratory disease.

Martin and his colleagues note that further development of biomarkers of susceptibility and effect could facilitate large scale studies examining the impact of HAP on health and disease in human populations. In the end, new biomarkers would: (a) improve epidemiological accuracy in association studies with health effect; (b) reduce the cost and complexity of monitoring intervention studies; (c) provide data for educating the public and policymakers about risk; and (d) inform clinicians and the public health community about human environmental exposures that are not well characterized.

Conclusion

China uses more coal than any other nation to meet the energy needs of its one billion citizens. In India, 55 percent of electrical power was generated by coal last year, and as austerity measures in Europe grow stronger, coal is becoming an attractive alternative to natural gas. But the more affordable option could also prove to be the more harmful, and potentially add to the illness and death tolls already linked to HAP exposure.

Martin and his colleagues have put together a comprehensive overview of the dangers posed by biomass fuels and the research gaps in assessing HAP threats. The article is a “must read” for anyone interested in public health.

 Study: Household air pollution: a call for studies into biomarkers of exposure and predictors of respiratory disease

Source: EurekAlert!

Miraculins to License Additional Preeclampsia Technology from Mount Sinai Hospital

Miraculins Inc. (TSX-V:MOM), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today its plans to add to its suite of maternal health biomarkers under license from Mount Sinai Hospital’s Samuel Lunenfeld Research Institute by signing a term sheet to license methods and reagents for detecting hydroxylated Hypoxia Inducible Factor 1 alpha (“HIF-1aOH”), a promising biomarker with potential in differentiating high and low risk pregnancies, including risk of preeclampsia. The technology is part of the pioneering research on preeclampsia and placental development being conducted by Dr. Isabella Caniggia, Senior Investigator at the Samuel Lunenfeld Research Institute, in collaboration with Dr. Martin Post, a Senior Scientist at The Hospital for Sick Children. Dr.Caniggia is also a member of Miraculins’ Scientific Advisory Board and is cross-appointed at the University of Toronto as a Professor in Obstetrics and Gynecology as well as Physiology.

In addition to its promise in maternal health and preeclampsia, HIF-1aOH also presents an opportunity as a cancer biomarker and of further note, the license will include unique monoclonal antibodies highly sensitive to HIF-1aOH and the exclusive rights to manufacture reagents that measure the biomarker using materials developed by Dr. Caniggia. Miraculins is currently advancing a development plan for a kit to detect and measure HIF-1aOHin bodily fluid, which if successful could lead to a near term commercial research use product and allow for more widespread research into the utility of this novel biomarker. The ultimate goal for the biomarker development program would be worldwide sales of the biomarker technology, either alone or in combination with other markers, in a diagnostic kit for the early detection of preeclampsia or as a pregnancy risk assessment tool.

“Since HIF-1a is central to proper placental development, early detection of abnormal HIF-1a regulatory mechanisms could one day provide tools to physicians and caregivers to differentiate high and low risk pregnancies. Although HIF-1a itself is a very promising biomarker, the hydroxylated form may prove to be important to diagnosing the severity of preeclampsia and to better manage this disease throughout pregnancy,” stated Dr. Isabella Caniggia, the discoverer of the markers that comprise Miraculins’ preeclampsia biomarker suite and inventor of the HIF-1aOH technology. “I am very eager to expand our continued work with the Miraculins team to achieve the goal of better outcomes for mothers and babies.”

“We are very pleased to expand our maternal health program and partnership with Dr. Caniggia and Mount Sinai Hospital’s Samuel Lunenfeld Research Institute,” stated Christopher J. Moreau, President and Chief Executive Officer of Miraculins Inc. “This program has been very successful to date, and recently produced a license agreement for the biomarker Endoglin with a major global diagnostic company. We look forward to continuing research into this promising biological pathway with the goal of developing additional preeclampsia diagnostic tools for this devastating disease of growing incidence worldwide.”

Source: Miraculins