Mr. Yossi Pollak, CEO of SightDx said, "We are very excited about the partnership with USAMRD-K. This award recognizes SightDx's success in bringing a high-throughput computer vision malaria diagnostic technology to the market and sets us on a path to launch a point of care version of the platform in remote locations and austere environments. USAMRD-K in Kisumu, Kenya serves as an ideal partner, given their extensive background in malaria clinical research and expertise in malaria diagnostics."
SightDx currently markets the Parasight device, a high-throughput malaria detection platform that uses computer vision technology to analyze blood samples for malaria parasites. The state-of-the-art digital cytometry technology combines cutting-edge computer vision algorithms, custom optics, and proprietary disposable cartridges, which allows for analyzing blood samples in a rapid, reliable and a completely automated fashion. The platform has shown ~98% sensitivity and ~98% specificity in clinical trials performed in Africa and India. The device is currently marketed throughout Europe, Africa and India with over 60 units having been placed in pathology laboratories and hospitals.
SightDx aims to develop and test a portable version of the malaria diagnostic technology which will also perform complete blood count, providing additional diagnostic information critical to health care providers operating in remote locations. In contrast to the current device that can hold 30 tests and features automated loading and scanning, the next generation device will scan a single cartridge of five tests and have significantly smaller dimensions, making it appropriate for smaller clinics in rural areas.
The project will be conducted in collaboration with Dr. John Waitumbi, senior scientist and chief of the Basic Science Laboratory at USAMRD-K, which is part of the Walter Reed Army Institute of Research (WRAIR). The USAMRD-K mission includes conducting regulated clinical trials for vaccines, drugs and diagnostic platforms for diseases of Africa and the world. In addition, USAMRD-K conducts surveillance, training, research and response activities related to emerging infectious disease threats as well being a partner in executing the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the President's Malaria Initiative (PMI).
"Malaria microscopy and rapid diagnostic tests (RDTs) have been the mainstay of malaria diagnosis for centuries and decades, respectively. If proven successful, the instrument from SightDx will help detect and quantify malaria parasites. It will also provide the patient's blood count (anemic status), an important parameter in the management of patients diagnosed with malaria," said Waitumbi. "This collaboration recognizes the expertise and capability of USAMRD-K to evaluate the performance of potential diagnostic devices for diseases that are endemic to Kenya and the region."
In 2015, there were 214 million new cases of malaria worldwide resulting in 438,000 malaria deaths. The WHO estimates that nearly 500 million malaria tests are performed annually to combat the disease. While microscopy and RDTs are the main diagnostic approaches, there is recognition of the need to take improved diagnostics to the "point of need." Such devices need to be inexpensive, quick, consistent and highly accurate. The development and launch of the point-of-care device for malaria diagnosis, featuring complete blood count, will allow for wider use of the platform to enable better patient management.