A portable diagnostic device designed by researchers at Cornell Engineering and Weill Cornell Medicine has been deployed in clinical trials in Uganda to identify cases of Kaposi’s sarcoma, a common but difficult to detect cancer that often signals the presence of a HIV infection.
Now, thanks to a $4 million grant from the National Cancer Institute Center for Global Health, the rollout is expanding to 11 sites across sub-Saharan Africa, including Kenya, Tanzania, Rwanda, Botswana and Malawi – where a shortage of diagnostic tests and pathology experts has resulted in long waits and sometimes erroneous results.
The diagnosis, deployed in Africa since 2017, is proving to be very precise.
By generating results within an hour at the point of care, the portable system, KS-COMPLETE, accelerates the speed of accurate diagnosis, and eventually treatment, for patients.
“We are looking to deploy technology that can change the paradigm for how Kaposi’s sarcoma is diagnosed in sub-Saharan Africa,” said project leader David Erickson, professor of mechanical engineering at Sibley College at Cornell Engineering, who developed technology with Dr. Ethel Cesarman, professor of pathology and laboratory medicine at Weill Cornell Medicine.
“We can hopefully reduce the time to results by sending the diagnosis back to where the patient is, without having to send it to an outside expert,” Erickson said. “If we are able to do this, we hope that the faster return of a result will allow the patient to access care more quickly and improve clinical results.”
Kaposi’s sarcoma (KS) is a cancer of the cells that line the blood or lymph vessels, and it usually appears as lesions on the skin, inside the mouth, in the lymph nodes, or in the lungs or digestive tract. One of the most common and deadliest cancers in sub-Saharan Africa, KS is often caused by immune suppression of HIV.
While pathological diagnosis is essential for the diagnosis of KS, unfortunately KS is most common in a part of the world where there is a critical shortage of pathologists and widely varying standards. The molecular approach provided by our new technologies should meet the need for an accurate and rapid diagnosis of KS.”
Dr. Ethel Cesarman, Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine
The KS-COMPLETE platform will consist of two components: SLICER and TINY.
The SLICER system automatically processes a biopsy sample into “micro-nuclei” which can be entered into the pint-sized TINY – short for Tiny Isothermal Nucleic acid quantification sYstem. TINY diagnostics then identifies the presence of Kaposi’s sarcoma-associated herpes virus by isolating and amplifying its DNA through a process called loop-mediated isothermal amplification.
In clinical tests based on 506 biopsies taken from patients at three HIV clinics in Uganda, TINY achieved 97% sensitivity, 92% specificity and 96% accuracy, according to an upcoming study by the team at project, which includes researchers from the University of California. , San Francisco, and the Kampala Institute of Infectious Diseases in Uganda.
In addition to expanding the deployment of KS-COMPLETE, the five-year grant – awarded June 1 – will focus on refining the SLICER system.
“The really difficult part is the upstream sample processing,” Erickson said. “Once that biopsy is out of a person, how do you crush all of that and put it in a state where it can be okay to go in the TINY? That turns out to be a really tough problem. A COVID test, for example , is just a small swab sticking out of your nose and a few cells.Here we have a large piece of skin that we need to treat quickly and efficiently.
Researchers hope that the KS-COMPLETE platform could eventually be used to diagnose other skin diseases beyond Kaposi’s sarcoma, as well as provide large-scale screening, in areas such as wastewater treatment. , for the coronavirus.