The National Institute of Biomedical Imaging and Bioengineering (NIBIB) www.nibib.nih.gov through researchers at Massachusetts General Hospital (MGH) www.massgeneral.org have developed a smartphone-based device that could reliably carry out molecular diagnoses in under an hour for about two dollars per patient.
It can take several days before a diagnosis is returned to the patient. In many cases, patients aren’t able to return for follow-up care either because they have to travel long distances to reach a clinic or can’t afford to take multiple days off of work.
This device could enable point-of-care cancer diagnostics in low to middle income or remote areas that often have high rates of mortality from cancer due to missed opportunities for treatment.
The new device called the “Digital Diffraction Diagnosis System” (D3) is made up of a smartphone and an imaging module consisting of a battery powered LED light and a lens. After a sample is collected, it is mixed with microbeads with specific antibodies attached.
The antibodies bind to molecules on the surface of the cancer cells and then the mixture is placed on a microscope slide and inserted into the imaging module so researchers can take pictures of the cell-bead mixture.
The researchers created an application for the smartphone to automatically upload the diffraction images to a secure cloud, and then transmitted to a server at MGH. The server than counts the total number of cells with beads attached as well as the total number of beads attached to a given cell. Based on the numbers, the sample is classified as high-risk, low-risk, or benign.
The researchers conducted a pilot study to determine if they could detect lymphoma cells in fine-needle aspirates of lymph nodes. In the eight person study, the device was able to accurately differentiate four patients with lymphoma diagnosis from four patients with benign lymph node enlargement. The findings were then confirmed by conventional pathology.