Transcript Document
Presenter Anna Daily Ph.D.-Senior Scientist March 9, 2012 Breast Health Providers Conference Why A New Approach to Breast Cancer Screening? Of women age 40 and over with insurance coverage only 50% participate in yearly screenings. Why women don’t participate: Dense Breast Tissue Lack of Facility Access Some find procedure painful Cost prohibitive for uninsured False Positive rate of 5% per exam= 50% over per patient lifetime Ascendant Diagnostics is Developing: A Low Cost Non-Invasive Screening Method for Breast Cancer Detects proteins present in tear samples Based on technology licensed from UAMS An inexpensive, highly accurate test that can diagnose cancer at earlier stages is highly sought after Why Tears? Easy and Quick to Collect Pain Free Non-invasive Contain Protein in High Concentrations Easy to Prep for Test SELDI TOF MS Figure 3: Tears will be collected Figure 4: Tears will be Collect Tear Sample using a tuberculine syringe with collected using a tuberculine the needle removed syringe with the needle removed Analyze Tears by Mass Spectrometry Figure**: Raw SELDI data indicating possible biomarkers at m/z 4038. Look for Differences Mass Spectrometry x104 4045.798 2.5 2.0 1.5 1.0 14691.861 0.5 16421.046 3122.430 17439.815 13899.559 8211.195 11719.514 0.0 2000 4000 6000 8000 10000 12000 14000 16000 Private Industry Quest LabCorp PeaceHealth Labs 18000 20000 m/z Intensity Bigger peak=more protein Intens. [a.u.] Separates samples based on Size Increasing size Drug Testing Monitoring Pain Medication Monitor metabolic disorders Genomics vs. Proteomics DNA Sequences Predictive of Risk Not Diagnostic Protein Structure and Function Diagnostic Imaging is the Gold Standard Technique Ionizing Radiation Breast Compression False Negative Rate False Positive Rate Mammography Yes YES 10-30% Up to 75% Ultrasound No No >30% Up to 65% PET Yes No 15-25% 25 to 75% MRI No No 1-15% 25 to 75% Tear Testing 80% Sensitive 75% Specific 90% Sensitive 90% Specific $75.00 per test vs. $200 for mammogram Regulatory Pathway CLIA: Clinical Laboratory Improvements Amendment Physicians Clinics and Hospitals supplied with prepackaged mailers Collect Tear samples from patients Results returned to Physician Tear samples go directly to partnered medical testing facility Ascendant Diagnostics team member carries out analysis Figure 5: Pathway from collection of samples to results. Carry out Mass Spectrometry Return results to Ascendant Diagnostics Timeline Licensed Technology; Business Case; Established Strategic Partnerships Protein Biomarker Identification; 2 cohorts of 300 patients; establish more partnerships; develop CLIA protocol 2011 2012 Clinical Validation; Marketing and Sales Team Build up Contract Development of POC Lab on a Chip and Contract Development of Reagents; Sales and Mktg. Other Cancer biomarkers; lines between treatment and level of protein 2013 2014 2015 Collaborations • University of Arkansas Statewide Mass Spectrometry Facility – – – – established February 2011 Acess to mass spectrometry instrumentation Collabroations on Grant applications Aid in development of CLIA based protocol • The Breast Center – established February 2012 – 300 tear samples over the next 2 years • Peace Health Labs – Established August 2011 – Aid and in development and testing of CLIA lab protocol • Winthrop P. Rockefeller Cancer Institute Women’s clinic (UAMS) – In Progress – 300 tear samples over the next 2 years Management Team Scientific Advisory Board Contact Information Omid Moghadam CEO 479-571-2592 [email protected] Anna Daily Ph.D. Scientist 479-571-2592 Benefits of Tear-Based Screening High Specificity Pain Free Non Invasive [email protected] Lower Cost Increase Early Detection Rapid Results