To overcome the disparity between the relative high effective cure rates in early intervention and high mortality rates associated with most diagnosis of oral cancer at a later stage (e.g. Stage III or Stage IV), there exists a need to screen and identify more at-risk patients that are currently going undetected in pre-cancerous stage or in the early stages of cancer progression (e.g. Stage I or Stage II). Addressing this need provides the opportunity to reverse or change adverse lifestyles to minimize risk of eventually developing oral cancer. In situations where cancer has already started, an early screening and intervention could maximize the effectiveness of the treatment.

 VigilantBIO’s oral cancer screening product answers this market need by providing an easy-to-use, low-cost and objective adjunctive screening kit specific for oral cancer. Saliva is a very desirable biofluid for disease diagnostics since it harbors a wide spectrum of analytes and is readily accessible without venopuncture. Via either a central lab (ELISA) model or a point-of-care (lateral flow chemical test strip) product offering, the VigilantBIO oral cancer screening products offer the following benefits:

  • Early detection specific for head and neck squamous cell carcinoma prior to observation of visual symptoms
  • Existing reimbursement codes available but also adaptable to credit-card nature of dental offices
  • Easy-to-use with minimal disruption for dental office business practice and model.


When commercializing screening and diagnostic technologies, two key biostatistic metrics are used to determine efficacy: sensitivity and specificity.

Sensitivity measures the probability of patients with disease that test positive. A highly sensitive test with a negative result is good at ruling out the disease.

Specificity measures the patients without disease who test negative. A highly specific test with a positive result is good at ruling in the disease.

Based on its two currently enrolling clinical trials, the University of Miami has been able to produce the following sensitivity and specificity percentages to-date for those salivary oral cancer biomarkers that are exclusively licensed to VigilantBIO.


Sensitivity Specificity
80% - 85% 88% - 100%a

a.  Franzmann EJ, Reategui EP, Carraway KL, Hamilton KL, Weed DT, Goodwin WJ. Salivary soluble CD44: a potential molecular marker for head and neck cancer. Cancer Epidemiol Biomarkers Prev 2005;14: 735-9.


To appreciate the significance of this data, please note the following comparison metrics to the pap smear, the “gold standard” for human papillomavirus (“HPV”) screening for squamous cell cervical cancer (or pre-cancer).


University of Miami Data
(for Oral Cancer)
Pap Smear
(HPV)
Conventional
Cytology*/**
Monolayer Liquid
Based Cytology*/**
Sensitivity 80%- 85% 72% 61%-66%
Specificity 88% - 100% 94% 82%-91%


* Coste J, Cochand-Priollet B, de Cremoux P, et al. (2003). "Cross sectional study of conventional cervical smear, monolayer cytology, and human papillomavirus DNA testing for cervical cancer screening". BMJ 326 (7392): 733.
** Kulasingam SL, Hughes JP, Kiviat NB, et al. (2002). "Evaluation of human papillomavirus testing in primary screening for cervical abnormalities: comparison of sensitivity, specificity, and frequency of referral". JAMA 288 (14): 1749–57.