Researchers receive Patent for Humanity award

November 16, 2016

Malaria has killed more people than any disease caused by a single organism, including small pox and the plague. Symptoms include high fever, copious sweating, nausea and vomiting, and shaking chills. While the industrialized world has been essentially malaria-free for more than half a century, the mosquito-borne malady continues to harm health and jeopardize lives in nearly one hundred largely tropical and subtropical nations worldwide. One of the biggest barriers to eradication has been the absence of a quick, inexpensive, and accurate test.

Now, thanks to a team of Case Western Reserve University researchers, developing nations will soon be in a better position to finally conquer malaria. The secret: a portable, battery-operated device that uses magnets and lasers to quickly and inexpensively detect the presence of the disease in the bloodstream.

The invention - the Magneto-Optical Detector (MOD) - earned a Patent for Humanity award last month from the U. S. Commerce Department's United States Patent and Trademark Office and will be recognized in a formal ceremony in Washington DC this month.

"With MOD, we wanted to close a big gap in identifying people with malaria," said Brian Grimberg, PhD, assistant professor of international health at the CWRU School of Medicine and co-leader of the development team. "It is hard to diagnose malaria accurately using current technology. The standard microscope test can generate up to 36 percent false positives and 18 percent false negatives. This means that many infected people are untreated and can die. Many others who don't have the disease get anti-malarial drugs unnecessarily, which wastes tight resources and contributes to drug resistance."

MOD is significantly more accurate than current point-of-care tests and can diagnose all forms of malaria at even very low concentrations. The cost is about $1 per test and results are reported in around a minute. (The current rapid malaria test takes 20 minutes. Microscopic tests take about an hour when conducted by a trained laboratory technician or pathologist.)

Malaria: An Ongoing International Plague

Although preventable and treatable, malaria is now actively transmitted within 97 countries, according to the World Health Organization. Half of the world's population, an estimated 3.4 billion people, is at risk. Of these, 1.2 billion are at high risk.

According to the latest WHO estimates, there were 214 million reported cases worldwide in 2015 and 438,000 reported deaths. Pregnant women are at special risk and fetal development may be compromised. About one in four child survivors of a severe brain-based form of malaria suffers long-term cognitive impairment.

The CWRU MOD team is led by Dr. Grimberg and Robert Brown, PhD, distinguished university professor in physics, with key research and development by senior research scientist Robert Deissler, PhD, mechanical designer/machinist Richard Bihary, visiting scientist William Condit, and undergraduate/technician Jason Jones, a CWRU alumnus. Except for Dr. Grimberg, all are members of the CWRU Department of Physics.

When malaria parasites consume red blood cells, they release iron-containing crystals called hemozoin - which possess magnetic properties - into the bloodstream. Magnets in MOD are placed near the blood sample, causing the randomly oriented crystals to align, reducing the amount of laser light that can slide through. The resulting laser change allows MOD to determine if someone is infected as well as establish the level of infection. And it only needs a single drop of blood.

"The Department of Physics at CWRU regularly conducts advanced research in fields ranging from dark matter to MRI," said Dr. Brown. "My colleagues on the malaria team and I work extensively in magnetic field research and fluid dynamics of magnetic and partially magnetic particles, making it a natural fit to become involved with this project. It is truly rewarding to be addressing fundamental physics problems and developing applications for improved human health."

Dr. Grimberg estimates that MOD can save anti-malaria organizations $1.2 billion annually on direct diagnostic savings, increased workforce productivity, and more efficient allocation of prevention and treatment resources. Also, MOD testing is easily administered outside of laboratory facilities, including in community and remote settings. As a result, care workers can bring accurate testing and diagnosis to towns and villages, instead of requiring patients to travel as many as 30 hours each way to a health clinic.

Currently a MOD prototype is in use in rural locations in Peru and Kenya, with scaled-up screenings starting in January in Kenya.

Collaboration with CWRU's Office of Research and Technology Management and Hemex Health

Dr. Grimberg and his colleagues are collaborating with Portland, Oregon-based Hemex Health, which provided funding and licensed MOD for commercialization and wider use. Next steps include shrinking the current shoe-box sized device further and equipping it to operate on solar power.

Some of Dr. Grimberg's earliest funding came from the school's Clinical and Translational Science Collaborative, which contributed almost $50,000 to his efforts.

Most recently, the Case Western Reserve University Office of Research and Technology Management helped in securing patent protection and connected the MOD team with Hemex Health, which plans to have the final version in trials in 2017 and released with regulatory approvals in late 2018. "This has been a true collaboration," said Dr. Grimberg. "That includes developing MOD with the Physics Department team, enlisting the invaluable support of the CWRU Office of Research and Technology Management, and taking advantage of the roll-out expertise of Hemex Health." The result is an interlocked team poised to dramatically alter how malaria is detected, paving the way for ultimate worldwide eradication.
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