Massing diagnostic efforts in Massachusetts

Diagnostics For All issues challenge grant for multi-institution Ebola partnership

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BOSTON—In the past decade, Massachusetts has grown to become a hub for life sciences, with dozens of academic and industry organizations calling the state home. And now, several of those firms are banding together in pursuit of a potential Ebola diagnostic.
The partnership will consist of Diagnostics For All, which will lead the undertaking, as well as 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 produce a field-robust product for test use in six months, based off of technology that Diagnostics For All has already been developing. Diagnostics For All’s test incorporates isothermal nucleic acid amplification on a paper substrate and will combine the biological, mechanical and electronic aspects of a molecular diagnostic into a single disposable device that will require a single finger-stick of blood and then provide a “yes/no” response in 45 minutes.
“The center is a funding agency; we’re charged with implementing the state’s 10-year, $1-billion life-sciences initiative, and this grant was made through the funding available through that initiative,” says Angus McQuilken, vice president for Marketing and Communications at the Massachusetts Life Sciences Center (MLSC). “That initiative was approved by our legislation and signed into law in June 2008, so we’re six years into it. We’re awarding funding on a regular basis to support projects like this, along with early-stage companies, work-force development efforts, capital projects … this is part of more than $545 million in investment that the center has made thus far to accelerate growth in our life-sciences sectors in Massachusetts, but also to catalyze innovation.”
Under this initiative, the MLSC will provide a $1-million challenge grant for the partnership, with a target for the partnership to raise an additional $4.5 million. Diagnostics For All is in talks with a number of parties to raise that amount, and Marcus Lovell Smith, president and CEO of Diagnostics For All, has said he is also seeking additional funding to support taking the device through to final manufacturing and clinical trials.
The company’s technology consists of patterning “channels and assay zones of water-repellant materials into a piece of paper roughly the size of a postage stamp. Biological and chemical assay reagents are then deposited in the wells. When blood, urine, saliva, sweat or other biological samples are applied to the device, the paper wicks the sample through the channels to the assay zones, without external pumps or power. Upon contact, the assay zone quickly changes color and results are then easily read by comparing the color change with a reference scale printed on the device. After use, the device can be easily disposed of by burning,” the company website notes.
“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. Richard Sacra, a faculty member at the University of Massachusetts Medical School, in a news release about the effort. “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.”
McQuilken tells DDNews that the partnership approached the MLSC about six months ago with regard to initiating this project. Given that “An important part of the center’s mission is to catalyze innovation that will improve global health,” he says, “this project was a great opportunity to accomplish that goal.”
“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,” according to Dr. Susan Windham-Bannister, president and CEO of the MLSC. “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.”
The U.S. Centers for Disease Control and Prevention (CDC) reports that as of Jan.y 23, there are 21,797 cases of Ebola in Guinea, Liberia and Sierra Leone, with 13,602 laboratory-confirmed cases and 8,675 deaths. The CDC adds that “cases in Liberia are currently doubling every 15 to 20 days, and those in Sierra Leone and Guinea are doubling every 30 to 40 days,” supporting the need for diagnostic tools to properly detect and contain Ebola infections.

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