OraLiva Inc's Target Clients
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Pathologists
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Dental Providers (Periodontists, Oral Maxillofacial Surgeons, GP Dentists, Hygienists)
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Medical Providers (ENT, Otorhinolaryngologist)
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Patients (Indirectly Through Above Providers)
PATHOLOGISTS
Omics Meets Cytopathology at the Point of Care for the First Time
For the initial product in the oral lesion diagnostic, Oraliva Inc’s C-AIDE-OC provides noninvasive, painless, reliable, clinically validated AI linked diagnostics for the detection of oral cancer and oral dysplasia. This SMART DIAGNOSTIC approach starting with oral cancer will be extended to multiple other essential cancers. The smart DX sensor suite includes a refined interface that is intended to increase the workflow efficiency of practicing pathologists while at the same time reducing the subjectivity of diagnosis of suspicious lesions including mild dysplasia. These diagnostic tools are backed by NIH sponsored multisite international clinical studies (See Scientific Progress) that have yielded highly accurate diagnostic models that encompass common benign lesion conditions, oral epithelial dysplasia and oral squamous cell carcinoma. These cloud-connected cytopathology tools leverage multiple data streams, powerful illness and wellness disease fingerprints and intuitive reports suitable for both expert and nonexperts. Please see our technology explainer video HERE.
DENTAL PROVIDERS
General Dental Providers Do Not Currently Have the Capabilities to Appropriately Manage Potentially Premalignant Oral Cavity Lesions
Most General Dentists lack the training and tools to comprehensively evaluate potentially premalignant oral cavity lesions. Dentists must rely on the patient history and visual inspection of the lesions to determine which patients to refer for invasive biopsy. Periodontists and Oral Surgeons face a similar dilemma when evaluating these lesions and are often forced to perform painful, invasive incisional biopsies on patients who are ultimately found to not have precancerous or cancerous changes in their lesion. The lack of a highly accurate, noninvasive tool for evaluating these lesion results in unnecessary referrals to specialists and unnecessary invasive biopsies. To help manage this diagnostic and risk assessment challenge, OraLiva 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 and allows dental providers to visualize early signs of cancer using 'cyto-signatures’ (See Scientific Progress). OraLiva’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 (pre-cancer). 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.
MEDICAL PROVIDERS
Primary Care Providers Do Not Currently Have the Capabilities to Appropriatley Manage Potentially Premalignant Oral Cavity Lesions, and Otolargologists (ENTs) are Forced to Biopsy Many Benign Lesions Since There is No Highly Accurate Noninvasive Technology for Evaluating These Lesions
Like dental providers, most primary care medical providers lack the training and diagnostic tools to provide a comprehensive work up of clinically evident suspicious oral lesions.
OraLiva’s C-AIIDE technology is a clinically useful technology that seamlessly fits into the diagnostic algorithm for potentially premalignant oral cavity lesions. It will allow clinicians to rapidly assess specific lesions for premalignancy or malignancy with a high degree of sensitivity and specificity, at the point of care. These capabilities will provide the following benefits to various stakeholders:
Reduce Patient Morbidity: Prevent unnecessary scalpel biopsies and/or referrals from dentists to specialists. The OraLiva C-AIDE technology will save patients time, money, and unnecessary discomfort as most oral mucosal lesions are benign without the presence of dysplasia. Importantly, the high level of diagnostic accuracy (See Scientific Progress) afforded by the OraLiva testing capabilities will result in the reduction of the problems inherent with over and under treatment of patients due to false positive and false negative results and provide results that are as accurate as histopathologic evaluation of an incisional biopsy.
Mitigate Patient Anxiety: Assessments conducted at the point of care will also save patients the anxiety that comes with waiting to see a specialist for further evaluation and the additional 3-7 days of waiting for scalpel biopsy results, all while being worried that they may have an early oral cancer. OraLiva’s potential to deliver test results in near real time at the point of care will help minimize anxiety about a potential diagnosis and will allow clinicians to better counsel patients about the next management steps of their lesion.
Increased Sampling Efficiency of Large Lesions and Multifocal Disease: Oral Surgeons, Periodontists, and Otolaryngologists routinely treat patients that present with multiple lesions or lone lesions that are very large in size, occasionally covering most of the oral cavity. These complex lesions present a significant challenge for the provider. The provider must decide how many punch or scalpel biopsies should be performed to avoid missing a region of dysplasia or early cancer while also attempting to define the priority locations for these biopsies. Likewise, there is an immediate conflict between the morbidity caused in the biopsies vs. the potential to miss a location of dysplasia, carcinoma in situ, or frank cancer. The noninvasive sampling procedure afforded by OraLiva C-AIDE allows for the sampling of larger areas and/or the completion of multiple mapping brush biopsies so that the entire lesion can be assessed.
PATIENTS
OraLiva’s C-AIDE Technology Allows for Oral Lesion Testing to be Completed More Efficiently and with Less Pain Than Conventional Tissue Biopsy Procedures.
Front line dental providers are very interested in having access to diagnostic tests that provide clinically actionable information to better inform management decisions, with an emphasis on tools that can help evaluate benign oral lesions and potential oral cancers. In the US alone, there are about 5.4M persons (2.5% of the general population) that have a benign oral lesion. Many of the lesions have chronic inflammation and are >50X more common than oral cancer and often persists for many years. These lesions have a small, but significant potential to transform into an oral cavity cancer. To help address this essential gap, OraLiva and partners have developed unique diagnostic capabilities for these oral lesions. The ability to provide highly accurate risk stratification of oral cavity lesions will give both expert and nonexpert providers the confident to manage more patients without a referral to a specialist which will reduce healthcare costs while improving the quality of care.