SBIR grant support is being sought by 20/20 GeneSystems, Inc. (20/20), a small biotech company, to help us advance what we believe will become the first blood test to be routinely employed to aid in the early detection of head and neck cancer. Despite recent advances in both diagnostic and therapeutic modalities, long-term prognosis for patients affected by advanced stage head and neck squamous cell carcinoma (HNSCC) remains dismal with 5-year survival less than 40%. This grim prognosis is in distinct contrast to the more than 80% chance of cure for those patients who present with early stage cancer. Unfortunately, more than two-third of patients with HNSCC are diagnosed only after the disease is advanced. Failure to diagnose this cancer early is mainly attributed to the unavailability of a screening test for high risk patients as well as frequent misdiagnosis of early stage cancer by primary physicians. An autoantibody immunoassay for head and neck squamous cell carcinoma (HNSCC) is expected to become a novel non-invasive tool for early diagnosis. Our long term strategy, which would become the subject of a Phase II SBIR grant application should Phase I work be successful, is to develop a "tobacco user's chip" to screen for both HNSCC and lung cancer in one blood sample, because current and former smokers are at high risk for both diseases. The serological test should have a significant impact on the quality of medical care for persons at risk, particularly for over 20% of the US population who are users of tobacco and/or alcohol products.
Public Health Relevance: A blood test for early detection of head and neck cancer could provide a cost-effective screening approach when applied to presently known high risk groups, who are: users of tobacco and/or alcohol, the immune-compromised, and those with premalignant lesions. It would enable a viable strategy for reducing the severe mortality rate of this disease.
Public Health Relevance: Project Narrative A blood test for early detection of head and neck cancer could provide a cost-effective screening approach when applied to presently known high risk groups, who are: users of tobacco and/or alcohol, the immune-compromised, and those with premalignant lesions. It would enable a viable strategy for reducing the severe mortality rate of this disease.
Project Terms: Advanced Development; Affect; Agreement; Alcohols; Applications Grants; Arm; Assay; Autoantibodies; Bacteriophages; Binding; Binding (Molecular Function); Bio-Informatics; Bioassay; Bioinformatics; Biologic Assays; Biological Assay; Blinded; Blood; Blood Plasma; Blood Sample; Blood Serum; Blood Tests; Blood specimen; CAT Scan, X-Ray; CAT scan; CT X Ray; CT scan; Cancer Staging; Cancer of Lung; Carcinoma, Non-Small-Cell Lung; Caring; Chemical Class, Alcohol; Classification; Clinical; Collaborations; Computed Tomography; Computerized Axial Tomography (Computerized Tomography); Computerized Tomography, X-Ray; Consult; Curative Surgery; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Disease; Disorder; Doctor of Philosophy; EMI scan; Early Diagnosis; FLR; Failure (biologic function); Feasibility Studies; Flooding; Floods; Forecast of outcome; Funding; Grant; Grant Proposals; Grants, Applications; HNSCC; Head; Head and Neck Cancer; Head and Neck Carcinoma; Head and Neck Squamous Cell Carcinoma; Hematologic Tests; Hematological Tests; Hematology Testing; Immune; Immunoassay; Kentucky; Legal patent; Lesion; Licensing; Lung Neoplasms; Malignant Head and Neck Neoplasm; Malignant Tumor of the Head and Neck; Malignant Tumor of the Lung; Malignant neoplasm of lung; Mediation; Medical; Methods and Techniques; Methods, Other; Modality; Molecular Interaction; Mortality; Mortality Vital Statistics; NSCLC; NSCLC - Non-Small Cell Lung Cancer; Negotiating; Negotiation; Neoplasm Staging; Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma; Patents; Patients; Peptides; Persons; Ph.D.; PhD; Phage Display; Phages; Phase; Physicians; Plasma; Population; Pre-Malignant; Premalignant; Process; Prognosis; Protein Biochips; Protein Chips; Protein Microarray; Protein Microchips; Proteomics; Publications; Publishing; Pulmonary Cancer; Pulmonary Neoplasms; Pulmonary malignant Neoplasm; Reticuloendothelial System, Blood; Reticuloendothelial System, Serum, Plasma; Rights; Risk; SBIR; SBIRS (R43/44); SCCHN; Sampling; Scientific Publication; Screening procedure; Serologic; Serologic tests; Serological; Serological Tests; Serum; Serum, Plasma; Small Business Innovation Research; Small Business Innovation Research Grant; Smoker; Specificity; Staging; Symptoms; Systematics; Techniques; Technology; Testing; Therapeutic; Tobacco; Tomodensitometry; Tomography, Xray Computed; Training; Translations; Tumor Staging; Tumor of the Lung; Universities; Upper arm; Validation; Work; X-Ray Computed Tomography; autoimmune antibody; bacterial virus; base; biomarker; cancer diagnosis; catscan; computed axial tomography; computerized axial tomography; computerized tomography; cost; disease/disorder; early detection; failure; head & neck cancer; head & neck tumor; high risk; innovative technologies; interest; lung cancer; nonsmall cell lung cancer; novel; outcome forecast; patient population; precancerous; public health relevance; screening; screenings; self reactive antibody; serology; tool; tumor; validation studies
