SBIR-STTR Award

This goal of this SBIR project is to develop a commercial grade Nanocytology system for FDA clinical trials and subsequent commercialization of a lung cancer risk stratification test to personalize lung cancer screening. Lung cancer is the leading cause of cancer deaths in the U.S. The reason for the lethality of lung cancer relates to its tendency to be diagnosed at a late stage, given that potentially curable stages of disease are often clinically silent. Existing approaches to screen lung cancer have been inadequate from either sensitivity or an efficacy/cost-effectiveness perspective. While low-dose CT (LDCT) has shown promise with its excellent sensitivity and specificity, limitation of LDCT is its unacceptably high false positive rate with most of the positive test results actually being false positives (due to the low prevalence rate) leading to overdiagnosis. Hence the two step approach wherein the first test (risk stratification) will be able to identify the patients with high risk followed by a more intrusive/expensive test such as LDCT (similar to Pap smear à colposcopy paradigm for cervical cancer) would be an ideal solution for lung cancer screening. NanoCytomics is developing a risk stratification test for lung cancer which would be low cost, highly sensitive, and minimally invasive and will be simple enough to be performed in a primary care office by means of a simple buccal swab of the cheek epithelium. In this direct to Phase II project, NanoCytomics will develop a self-contained high-throughput partial wave spectroscopic (HT-PWS) microscope that is compliant with all US and International standards of manufacturing as well as that is regulatory compliant will be developed. PWS microscopy (or simply, Nanocytology) developed at Northwestern University has extensively been shown to quantify the statistical properties of cellular nanoscale organization and identify early cancerous changes in buccal epithelial cells, which are associated with lung cancer. In the previous Phase I-type research, NanoCytomics had developed a bread board based high-throughput system prototype that is two orders of magnitude faster than the first generation PWS microscope as well as developed a robust standard operating procedure for buccal PWS that improved the acceptance rate of samples to ~ 100%. As a next step, NanoCytomics endeavors to develop a self-contained commercial grade HT-PWS system with an embedded PC module for multi-center FDA trials and subsequent commercialization. The Phase II project will also focus on clinical prediction rule development and a blinded validation study. Our vision is that PWS analysis of cells brushed from the buccal mucosa may become a risk stratification tool that can be performed by a primary care physician as part of an annual exam to identify the subset of patients who may benefit from further screening. If the buccal PWS test is positive, the patients will be offered more expensive/invasive tests such as Low dose CT.  

Public Health Relevance Statement:
Project Narrative Lung cancer is the leading cause of cancer deaths in the U.S. and the survival rate dramatically depends on the stage at which it is diagnosed. This SBIR direct to Phase II project will lead to the development of a low cost, minimally intrusive and accurate risk stratification test for lung cancer among current/past smokers to identify the subset of patients who needs low dose CT screening.

Project Terms:
abstracting; Age; American; Anxiety; Architecture; Area; base; Biophotonics; Blinded; Bread; Brush Cell; Cancer Etiology; Cancer Patient; cancer risk; Cancerous; carcinogenesis; Cells; Cessation of life; Cheek structure; Clinical; clinical application; Clinical Trials; Colon; Colposcopy; commercialization; cost; cost effectiveness; Data; Data Set; design; Development; Diagnosis; diagnostic accuracy; Diagnostic Neoplasm Staging; Diagnostic tests; Disease; Distant; Ensure; Epigenetic Process; Epithelial Cells; Epithelium; follow-up; Generations; Genetic; Goals; high risk; Histologic; Histology; improved; inclusion criteria; International; Investigation; Lead; Lesion; Low Prevalence; Low-Dose Spiral CT; Lung; Malignant neoplasm of cervix uteri; Malignant neoplasm of lung; Malignant Neoplasms; Measures; Microscope; Microscopy; minimally invasive; Molecular; mortality; Mucous Membrane; nanoscale; neoplastic; novel; Optics; Oral mucous membrane structure; Ovarian; Pancreas; Pap smear; patient subsets; Patients; Phase; Population; Positive Test Result; Predictive Value; Prevalence; Primary Care Physician; Primary Health Care; Procedures; product development; Property; prototype; Radiation; Receiver Operating Characteristics; Refractive Indices; Research; research and development; Research Design; Risk; Sampling; screening; Screening for Lung Cancer; Sensitivity and Specificity; Small Business Innovation Research Grant; Smoker; Smoking; Staging; Stratification; Subgroup; Survival Rate; Swab; Symptoms; System; Techniques; Technology; Testing; tool; Translating; Universities; Validation; validation studies; Variant; Vis

This goal of this SBIR project is to develop a commercial grade Nanocytology system for FDA clinical trials and subsequent commercialization of a lung cancer risk stratification test to personalize lung cancer screening. Lung cancer is the leading cause of cancer deaths in the U.S. The reason for the lethality of lung cancer relates to its tendency to be diagnosed at a late stage, given that potentially curable stages of disease are often clinically silent. Existing approaches to screen lung cancer have been inadequate from either sensitivity or an efficacy/cost-effectiveness perspective. While low-dose CT (LDCT) has shown promise with its excellent sensitivity and specificity, limitation of LDCT is its unacceptably high false positive rate with most of the positive test results actually being false positives (due to the low prevalence rate) leading to overdiagnosis. Hence the two step approach wherein the first test (risk stratification) will be able to identify the patients with high risk followed by a more intrusive/expensive test such as LDCT (similar to Pap smear à colposcopy paradigm for cervical cancer) would be an ideal solution for lung cancer screening. NanoCytomics is developing a risk stratification test for lung cancer which would be low cost, highly sensitive, and minimally invasive and will be simple enough to be performed in a primary care office by means of a simple buccal swab of the cheek epithelium. In this direct to Phase II project, NanoCytomics will develop a self-contained high-throughput partial wave spectroscopic (HT-PWS) microscope that is compliant with all US and International standards of manufacturing as well as that is regulatory compliant will be developed. PWS microscopy (or simply, Nanocytology) developed at Northwestern University has extensively been shown to quantify the statistical properties of cellular nanoscale organization and identify early cancerous changes in buccal epithelial cells, which are associated with lung cancer. In the previous Phase I-type research, NanoCytomics had developed a bread board based high-throughput system prototype that is two orders of magnitude faster than the first generation PWS microscope as well as developed a robust standard operating procedure for buccal PWS that improved the acceptance rate of samples to ~ 100%. As a next step, NanoCytomics endeavors to develop a self-contained commercial grade HT-PWS system with an embedded PC module for multi-center FDA trials and subsequent commercialization. The Phase II project will also focus on clinical prediction rule development and a blinded validation study. Our vision is that PWS analysis of cells brushed from the buccal mucosa may become a risk stratification tool that can be performed by a primary care physician as part of an annual exam to identify the subset of patients who may benefit from further screening. If the buccal PWS test is positive, the patients will be offered more expensive/invasive tests such as Low dose CT.  

Public Health Relevance Statement:
Project Narrative Lung cancer is the leading cause of cancer deaths in the U.S. and the survival rate dramatically depends on the stage at which it is diagnosed. This SBIR direct to Phase II project will lead to the development of a low cost, minimally intrusive and accurate risk stratification test for lung cancer among current/past smokers to identify the subset of patients who needs low dose CT screening.

Project Terms:
Age; American; Anxiety; Architecture; Area; base; Biophotonics; Blinded; Bread; Brush Cell; Cancer Etiology; Cancer Patient; Cancerous; carcinogenesis; Cells; Cessation of life; Cheek structure; Clinical; clinical application; Clinical Trials; Colon; Colposcopy; commercialization; cost; cost effectiveness; Data; Data Set; design; Development; Diagnosis; diagnostic accuracy; Diagnostic tests; Disease; Distant; Ensure; Epigenetic Process; Epithelial Cells; Epithelium; follow-up; Generations; Genetic; Goals; Harm Reduction; high risk; Histologic; Histology; improved; inclusion criteria; International; Investigation; Lead; Lesion; Low Prevalence; low-dose spiral CT; Lung; Malignant neoplasm of cervix uteri; Malignant neoplasm of lung; Malignant Neoplasms; Measures; Microscope; Microscopy; minimally invasive; Molecular; mortality; Mucous Membrane; nanocytology; nanoscale; neoplastic; novel; Optics; Oral mucous membrane structure; Ovarian; Pancreas; Pap smear; patient subsets; Patients; Phase; Population; Positive Test Result; Predictive Value; Prevalence; Primary Care Physician; Primary Health Care; Procedures; product development; Property; prospective; prototype; Radiation; Receiver Operating Characteristics; Refractive Indices; Research; research and development; Research Design; Risk; Risk stratification; Sampling; screening; Screening for Lung Cancer; Sensitivity and Specificity; Small Business Innovation Research Grant; Smoker; Smoking; Standardization; Subgroup; Survival Rate; Swab; Symptoms; System; Techniques; Technology; Testing; tool; Translating; Universities; Validation; validation studies; Variant; Visi