The Problem:  In 2020, 1.8 million new cases of cancer were diagnosed in the US, and over 600,000 people died from cancer. Many existing diagnostic methods are expensive and focus on late-stage disease, and current screening methods lack the diagnostic sensitivity detect early-stage disease. There is an unmet need for a clinically validated screening technology that can rapidly and reliably identify cancers at the earliest stage with high sensitivity and specificity at the point of care (PoC).
 

The Solution:  OraLiva Inc. and partners have developed a platform to digitize biology using sensors that learn. This award-winning programmable platform has been adapted for oncology screening applications for use at the PoC and allows clinicians to see early signs of cancer using 'cyto-signatures’. OraLiva Inc’s proprietary "C-AIIDE" (Cytology Artificial Intelligence IDEntification) technology allows for multiparameter single-cell measurements to be completed in near real-time, using several cross-indication biomarkers to develop new variables in assessing various states of dysplasia, the precursor to malignant tumor / lesion / polyp development. The “lab in a kit” and algorithm are designed to augment current diagnostic capabilities, including flow cytometry, tissue biopsy/histology and lab-based manual cytology tests, which are less accurate and more costly to run per test.  Please see our technology explainer video HERE.

​

First Indication for Use: OraLiva Inc’s initial application targets oral cancer which has one of the worst outcomes and highest expense of all cancers. The challenge is in the detection of oral dysplasia; there are 15x more oral dysplasia than oral cancer. C-AIIDE will be the only product on the market that has the capability to assess 5 diagnostic categories to include 3 dysplastic categories. C-AIIDE will also provide assessments in under 30 minutes at a fraction of the cost of other omics technologies (e.g., liquid biopsy) at the PoC. This approach has been validated by a 999 patient prospectively recruited, clinical study, the largest potentially malignant oral lesions ever completed. 
 

The Future:  OraLiva Inc. plans to disrupt the diagnosis and management of several types of cancer with our platform for cancer cytopathology.