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Breath Analysis For Lung Cancer Early Detection Ori Lirana, Manal Abud-Hawab, Maya Ilouzea,c, Naomi Gai-Mora, Shlomi Dekela, Alon Ben-Nund, Amir Onna, Jair Bard, Douglas Johnsone, John Wellse, Stuart Millstonee, Paul A Bunn Jrf, , York Millerf, Robert L. Keithg, Brad Rikkef, Fred R Hirschf , Hossam Haickb and Nir Peleda,c [email protected] * aThoracic Cancer Research and Detection Center, Sheba Medical Center, Tel-Aviv, Israel; bThe Department of Chemical Engineering and Russell Berrie Nanotechnology Institute, Technion – Israel Institute of Technology, Haifa, Israel; cDavidoff Cancer Center, Rabin Medical Center d Institute of Oncology, Sheba Medical Center, Israel; e Florida Radiation Oncology Group, Fl, USA; f University of Colorado Cancer Center, Denver, CO, USA; g Denver VA Medical Center, Denver, CO, USA Introduction • 150,000 new lung nodules are detected annually in US, while only minor percentage of them is malignant. • Final diagnosis requires biopsy and/or surgery. • Screening for Lung Cancer was proven to reduce the related mortality by 20%. • The screening program suffers from high false positivity (96% out of the 24% positive CT scans; NLST study). Methods Results Patients Lung cancer patients and matching High risk control patients were recruited to the study 358 subjects were enrolled : Israel: 174; Denver: 111; Florida: 73. 213 lung cancer patients: among 62 early disease and 143 advanced stage. 145 patients did not have cancer Florida Exhale Breath Analysis by E-nose Exhaled air collection: Discrimination between control and lung cancer • Volatile Organic Compounds (VOCs) are organic metabolites that are released by the cancer cells and/or by the surrounding environment. Discrimination between early and advanced disease 8 LC Control 6 Canonical 1 4 • Our previous studies showed that: 2 0 • Cancer cells show specific VOCs signature. -2 LC Control • Cancer cells show specific VOCs signature per histology and genetic profile. Delivering to a reference lab (Technion, Israel) : 1. Heating to evaporate the VOC in inert environment conditions. 2. Analyzing by GCMS and Artificial Olfactory System (gold NanoParticles). Cell line study showing different VOCs signature in NSCLC vs. SCLC and sub-histologies (NanoMedicine 2012) Sensitivity Specificity Accuracy Control / LC 93.87% 95.65 % 94.44% Early LC /Advanced LC 83.33% 91.66 % 89.58% Israel Exhale Breath Analysis by E-nose Output Sorbent Tube N2 or Vacuum Input Glass Cover Discrimination between early and advanced disease Discrimination between control and early lung cancer 2 Cell Lines 3 1 Hot Plate GC-MS & SPME 0 Canonical Score Sorbent Material Canonical Score Thermal Desorption 2 -1 -2 1 0 -1 -3 -2 M FC -4 M FC -3 Early stage Advanced LC Control Early LC M FC Aim of the Current Study: To detect lung cancer and its stage by exhaled breath analysis. Array of Au NP Chemiresistors ROC Sensitivity Specificity Accuracy Control / Early LC 81.25% 90.32% 85.11% 0.81048 Control / Advanced LC 81.25% 87.10% 82.11% 0.83065 Early LC /Advanced LC 80.26% 75% 78.75% 0.75293 AUC Conclusion: Breath analysis discriminated malignant from benign conditions in a high-risk cohort based on volatile signature. Furthermore, it discriminated between early versus advanced disease. These achievements stand in consistency with the requirements of society for rapid and early diagnosis of diseases as a part of therapeutic approach and facilitating rapid treatment.