Molecular diagnostics firm Quanterix is collaborating with the Forsyth Institute and Beth Israel Deaconess Medical Center to apply its single molecule array (SiMoA™) platform toward the development of a diagnostic for active tuberculosis (TB). The partners will work together to validate low abundance protein biomarkers of active disease, and develop a simple, fast test suitable for use in countries with high TB burden.
The Forsyth Institute has identified a panel of M. tuberculosis markers in the urine of human patients with active TB. However, Quanterix claims, current protein detection platforms aren’t sensitive enough to detect the proteins in urine or blood. “Using SiMoA, we are routinely able to improve the sensitivity of existing immunoassays by more than 1,000-fold, enabling accurate measurement of analytes that have previously been considered undetectable,” states David Duffy, Ph.D., vp for research.
Quanterix is focused on developing ultra-sensitive detection systems for use in research and in vitro diagnostics. Its SiMoA technology is based upon the isolation of individual immunocomplexes on beads using standard ELISA reagents. The process involves loading beads with or without labeled immunocomplexes into arrays containing femtoliter-sized wells. The arrays are then sealed in the presence of the enzyme substrate and fluorescently imaged. Because fluorescent products of the enzyme-substrate reaction are confined in a 50 femtoliter volume, a high concentration of product is essentially generated within just seconds, which can easily be detected.
The firm claims that by utilizing high-density arrays containing 50,000–500,000 wells, hundreds to thousands of individual immunocomplexes can be detected simultaneously, and isolating single immunocomplexes gives rise to a substantial increase in sensitivity compared with bulk, ensemble detection methods employed in traditional immunoassay technology.
Quanterix is exploiting its technology for a range of clinical and research applications. Its AccuPSA™ test is being developed as an ultra-sensitive assay for monitoring prostate-specific antigen levels for identifying prostate cancer patients at risk of disease recurrence. The firm is in addition developing a diagnostic biomarker panel for Alzheimer disease and potentially for other neurological disorders including Parkinson disease, bipolar disorder, stroke, and traumatic brain injury.
A collaboration between Quanterix and Sony DADC is in addition developing consumables based on an optical disc format, which will enable the fluidic sealing and isolation of single molecules in arrays, as the basis of an automated platform.