Governor Deval Patrick and the Massachusetts Life Sciences Center (MLSC) today announced a $1 million challenge grant to support a partnership of life sciences companies, NGO’s and academic institutions, led by Diagnostics For All, that is working to develop an improved, fast and accurate diagnostic test for Ebola.
Participating organizations in the partnership include Diagnostics For All (DFA), Harvard University, the Broad Institute, UMass Medical School, GE Healthcare, Cambridge Consultants, Eiken, BBI Solutions, IMPACT Consultants and WellBody Alliance in Sierra Leone.
The goal of the partnership is to speed the launch of an improved Ebola diagnostic tool to within months versus years. The test, incorporating isothermal nucleic acid amplification on a paper substrate, is simple to administer and is the first of its kind to offer disposable molecular diagnostics (MDx) capabilities without requiring analysis in a laboratory or additional instruments, as needed for current MDx tests. The reduced cost and ease of use is expected to facilitate earlier diagnosis of Ebola and in many more settings than is currently possible.
“As the world’s leader in life sciences, Massachusetts has a unique global platform for bringing innovations from the drawing board to the patient, from inspiration to commercialization, and from ideas to cures,” said Governor Patrick. “Through this investment and the work of the partnership, Massachusetts will play a central role in developing technologies that can control the spread of Ebola and save many lives as a result, in Africa and here in the United States.”
A press briefing was held today in Nurses Hall at the Massachusetts State House to announce the grant and partnership. Speakers included Governor Patrick, MLSC President & CEO Susan Windham-Bannister, Diagnostics for All President & CEO Marcus Lovell Smith, Dr. Richard Sacra, a faculty member at the University of Massachusetts Medical School who was cured of Ebola in the United States after working in Liberia, and Professor George Whitesides who is the Woodford L. and Ann A. Flowers Professor at Harvard University and the Founder of Diagnostics For All.
“The life sciences sectors are so important to our state’s economy, but more importantly, they enable Massachusetts to make major contributions to the quality of life for people all around the world,” said Susan Windham-Bannister, Ph.D., President & CEO of the Massachusetts Life Sciences Center. “The Life Sciences Center is proud of the partnership that is stepping forward to take a leadership role in the fight against Ebola, and we are pleased to support their important work with our challenge grant.” As of December 2014, there have been nearly 18,000 confirmed or suspected cases of Ebola during the current outbreak, with approximately 6,400 deaths in West Africa.
Ten individuals have been treated for Ebola infection in the United States, including amongst doctors who traveled to West Africa to help combat the outbreak. Finding a quick, accurate and early diagnosis of Ebola is critical to containing and effectively treating the disease. At this time, the only tests available are generally time- and labor-intensive, and not necessarily sensitive enough to detect the disease at the earliest onset of symptoms. Also, there is currently no available tool for this early molecular diagnosis and no way to distinguish the cause of fever in villages, out on the streets, and in remote areas, contributing to the extreme difficulty in identifying individuals ill with Ebola. Laboratories are overwhelmed and many of those that die from Ebola do so without ever being tested.
Mr. Lovell Smith stated, “The core vision of the Ebola diagnostic program is to create the world’s first molecular assay in a disposable low-cost format that entirely eliminates the need for instrumentation. We believe this can have a deep impact on the Ebola crisis, as well as in other areas of infectious disease that are threatening and will threaten populations worldwide.”
The MLSC will provide the partnership with a $1 million challenge grant with the goal of delivering a field-robust product for test use in six months. The grant establishes a target for the partnership to raise an additional $4.5 million, and Diagnostics For All is in detailed discussions with several parties for this amount. Mr. Lovell Smith further noted that he is seeking additional funding in order to take the device through to final manufacturing and clinical trials.
Most molecular diagnostic technology requires instrumentation and laboratory procedures, whereas Diagnostics for All’s device will incorporate the biological, mechanical and electronic aspects of a molecular diagnostic into a single disposable device. The device will accept a single finger-stick of blood and provide a clear “yes/no” response in 45 minutes.
The partnership effectively accelerates the program. By teaming with some of the best companies and institutions in the world, in their respective fields, Diagnostics For All expects to be able to bring this device to the field within a six-month period.
“Rapid testing at the point of care will make a HUGE difference for the triage process in West Africa, and may well save hundreds of lives in the first month it is available!” said Dr. Sacra. “In many facilities, where lab testing for Ebola is not available, it requires burdensome specimen transport and diagnostic results are often delayed, sometimes over 24 hours, which this rapid diagnostic technology would avoid.”