SensoDX NIDCR SBIR Fast Track Project advances to Phase II

InteliSpark client SensoDX II LLC  awarded the Phase II portion of a National Institute of Dental & Craniofacial Research Fast Track Small Business Innovation Research (SBIR) . The grant is for the SBIR project “Lab-on-a-Chip-Based System for Detection and Monitoring of Oral Cancer in Dental Settings.” SensoDX II focuses on creating state-of-the-art multi-parameter point-of-care diagnostic solutions that provide test information directly to patients and healthcare providers through intuitive mobile health interfaces.

Oral cavity and pharynx cancers are among the most serious cancers. There are about 400,000 incidents globally. In the U.S., the 5-year survival rate is about 64% among the lowest for all forms of cancer. When diagnosed during an early stage, the survival rate increases dramatically to 83%. However, oral cavity and pharynx cancers are among the most expensive cancers to treat due to the fact that most cases are advanced at the time of diagnoses.

Under the SBIR project, SensoDX fast Track application seeks to shift the current clinical practice paradigm for screening and diagnosis of potentially malignant oral lesions by moving away from the sole reliance on invasive scalpel biopsies followed by expensive and time consuming pathology exams to a new paradigm whereby noninvasive brush biopsies are combined with a state-of-the-art `cytology-on-a-chip' system for on the spot analysis of samples. This new technology will afford for the first-time single cell analysis of cytology specimens at the point-of-care. These powerful chip-based tools, along with new diagnostic models, have strong promise to improve the way screening and diagnosis of oral cancer is completed on a global basis.

The SensoDX OraTechTM sampling device and integrated OraTechTM cartridge together are projected to form the first effective adjunctive diagnostic aid capable of management of malignant and potentially malignant oral lesions on a rapid time frame with high sensitivity and high specificity. Diagnostic models based on biomarker data derived from these powerful chip-based tools, alongside lesion characteristics obtained from a customized mHealth App will allow for an elegant data fusion process to occur whereby lesion characteristics, risk factors and the numerous cytology factors yield the desperately needed clinical insights for patients suffering from oral cancer.

In second major phase, the consumables will be scaled, manufacturing processes will be developed and the instrumentation and cartridges will be validated using banked specimens.

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