Unmet Need / Invention Novelty: Early cancer detection leads to increased survival rates in patients. However, current biomarker assays to detect circulating tumor DNA and proteins lack the sensitivity needed to detect the earliest stages of cancer development.
Technical Details: Johns Hopkins researchers have developed a novel assay to detect circulating cancer proteins in the femtomolar range (fM, 10-15 M), a sensitivity that can detect the earliest stages of cancer development. The assay, Single-Molecule Analysis by Shape (SMASH), utilizes microfluidic chip technology to non-invasively detect mutant proteins specific to cancer cells in fluid samples with greater specificity and sensitivity than current methods. Precise detection of cancer proteins at fM concentrations occurs after fluid samples are applied to the microfluidic chip capture surface, bound by customizable capture antibodies, and spatially resolved using time-stream total internal reflection (TIRF) microscopy. SMASH has been validated using peripheral blood samples from cancer patients and healthy donors to detect mutant p53 or its autoantibodies in close to 90% of ovarian cancer patients but not in any healthy subjects. SMASH can be customized to detect individual proteins or multiplexed in order to detect combinations of cancer protein biomarkers in patient fluid samples.
- Value Proposition: Broad analysis of single-molecule imaging to characterize disease-associated proteins in the blood
- High sensitivity allows use to detect, diagnose, and/or study disease at the earliest stages
- Significantly increases both sensitivity and specificity of existing biomarker detection assays
- Versatile applications include multiplex and high-throughput formats for large-scale disease analyses
Looking for Partners to: Develop & commercialize the technology as a highly sensitive and specific early disease detection method.
Stage of Development: Pre-clinical
Data Availability: Prototype tested on ex vivo clinical samples
Inventors: Chien-Fu Hung, Chin-Ping Mao, Jie Xiao, Shih-Chin Wang, T.C. Wu
Publications: Sci Adv. 2021 Aug 11;7(33):eabg6522
