INDUSTRY NEWS
Corgenix and Fio Combine Rapid Ebola Test with Automated Analysis and Data Capture to Improve Frontline Care and Case Tracking
Corgenix Medical Corporation and Fio Corporation are working together to integrate two technological advances to help end the Ebola outbreak in West Africa: a rapid test, backed by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation, that can detect the virus in minutes; and a mobile device, which is being adapted with further funding from the Gates Foundation, to analyze and upload results directly to a central data system.
Fio is adapting its Deki™ Reader to work with the Corgenix ReEBOVTM Antigen Rapid Test for the Ebola virus, which recently received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and was listed as eligible for procurement by the World Health Organization (WHO). Combining these technologies will give suspected Ebola patients in the most remote, resource-poor settings access to automated test results. Results will then immediately be transmitted to Fio’s data system, Fionet™, capturing vital information that is currently missed or delayed.
“This collaboration makes testing more accessible to those at risk and data more readily available to those managing the outbreak, a combination that the Gates Foundation identified and mobilized,” said Dr. Michael M. Greenberg, chairman and CEO of Fio. “The resulting technology will expand the capability to fight Ebola now and strengthen national health systems beyond the current crisis.”
Corgenix researchers on the ground in Sierra Leone have already started using smartphones to transmit images of rapid Ebola test results to the Fionet data system. Together with Fio’s tools for case and contact mapping, this capability offers governments and other organizations responding to the outbreak a way to track the disease in real time.
“We’re taking the fight against Ebola to another level with Fio’s data collection and management, which is critical to the success of rapid testing,” said Douglass Simpson, Corgenix president and CEO. “This marks a tremendous advancement in Ebola testing, and it lays the groundwork for a strong and productive partnership between our two companies on future projects.”
The instant traceability of infected or potentially infected individuals— knowing test results, locations, and movement over time and across borders—is essential to containing the spread of the Ebola virus and other highly contagious diseases.
Both companies will continue to work together to integrate the two technologies for decentralized Ebola virus testing throughout West Africa. Beyond the current crisis, this will serve health systems more broadly to better manage future outbreaks, as well as other infectious diseases in the region, such as Lassa virus.
Fio’s Deki Reader, which is already CE-marked for use with rapid tests that detect malaria and dengue fever, is also being adapted for use with the Corgenix ReLASV® Antigen Rapid Test for the Lassa virus. Fio received a Gates Foundation grant in December 2014 to adapt its Deki Reader to analyze rapid Ebola tests and transmit results to Fionet to be
integrated with case and contact management tools. A few weeks later, Corgenix received two grants, one from the Gates Foundation and one from the Paul G. Allen Family Foundation, to advance the company’s development of an Ebola rapid test kit.
Both the ReLASV® Antigen Rapid Test and the ReEBOVTM Antigen Rapid Test have not been cleared for routine diagnostic use by the U.S. Food and Drug Administration.
The ReLASV® Antigen Rapid Test is CE-marked for diagnostic use in EU and other countries that recognize the CE mark.
The ReEBOVTM Antigen Rapid Test is not CE-marked and may only be used as a diagnostic device under the conditions of the Emergency Use Authorization issued by the U.S. Food and Drug Administration.
University of Rochester Medical Center Joins the National Institute for Pharmaceutical Technology and Education (NIPTE)
The National Institute for Pharmaceutical Technology and Education, Inc. (NIPTE) is pleased to announce that the University of Rochester Medical Center (URMC) has become its 14th member institution. Its admission has been unanimously approved by the Board of Directors followed the unanimous vote by the Faculty Committee.
URMC brings on board its vast experience and significant capabilities in the clinical trials supply chain management and monitoring through its Clinical Materials Services Unit (CMSU). It provides a full array of investigational drug/device services for many large, multi-center, multi-year clinical trials being conducted by the URMC, external academic medical centers, pharmaceutical, biotech, and contract research organizations. It currently acts as the "central pharmacy" for the National Institutes of Health’s NeuroNEXT network and is actively involved in drug development research through its NIH-funded Clinical and Translational Science Institute (CTSI) and Center for Human Experimental Therapeutics (CHET). Professor Karl Kieburtz, MD, MPH, a prominent clinical neurologist and URMC senior administrator who leads CTSI, will serve on the NIPTE Board of Directors.
NIPTE is a non-profit research organization headquartered in Minneapolis, MN, whose membership includes 14 top US universities in pharmaceutical science and engineering. Current members are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland - Baltimore, University of Michigan, University of Minnesota, University of Rochester, and the University of Wisconsin.
Zarxio Approval allows Biosimilar Competition to Begin
The US Food and Drug Administration has approved the first drug in the US that was developed through the recently established biosimilar regulatory pathway, clearing the way for competition in that arena to commence, according to Fitch Ratings.
Pharmaceutical Outsourcing | 68 | March/April 2015
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