Raghu Kannan “THE NEW GOLD STANDARD IN COMPANION DIAGNOSTICS”

Current methods of detection IHC: Dako –in accurate PCR –amplifies all genes FISH –works well; however, microscopic visualization of tumor regions is difficult First Target: NSCLC Quantify proteins Quantify genes Effective treatment plan Detects and quantifies proteins in tumor tissue.

Lung Cancer (2014) Incidence 221,200; Mortality: 158,040 The heterogeneity of NSCLC makes effective treatment dependent on knowledge of the patient’s tumor biomarkers (and mutations) Cost of targeted therapy: $100,000 A diagnostic test platform that enables identification and quantitation of all types of tumor biomarkers (and mutation) is needed

Platform Technology: Gold nanorod mediated targeted histochemistry” (GNR-HC). Can identify and precisely quantify biomarkers in human tissues Highly sensitive. Can detect and quantify all classes of tumor biomarkers (e.g., proteins, mutations, gene fusion, copy number variants)

Business model. Diagnostic kit supplied to pathology laboratories. Oncologists –order to provide effective treatment plan. Pharmaceutical companies use as companion diagnostics. Market strategy Start up: Golden Diagnostics IDE; PMA pathway $250K for Pre-IDE phase $1-$1.5 million for IDE and PMA approval

Raghu Kannan –Business development and nanotechnology Co-founder of three start-ups; raised more than $3 million in funding. Gerald Arthur –Board Certified Pathologist Partners and potential partners Regulatory specialists –Dr. Anandhi Upendran Industry contacts –Eli Lilly for providing human samples and expertise