Cepheid: Delivering a Better Way Dieneke Brockmans March 14, 2017 1 Cepheid
Our Mission Delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere. 2 Cepheid
Molecular Testing Made Easy with Xpert Accurate and Easy Same Cartridge Format All Tests, All Users Universal Sample Prep All Specimen Types 3 Cepheid
The GeneXpert Workflow is Fast and Easy 1 4 Cepheid Obtain samples stored in the Cepheid Transport Reagent Transfer the sample to the cartridge 1 2 3 Supported Sample Types Urine 2, Vaginal, Endocervical specimens 1. Representative workflow of Xpert CT/NG and Xpert TV assays 2. The Xpert TV assay is approved for female urine only. Both male and female urine samples are FDA-cleared for use on the Xpert CT/NG assay. Insert Cartridge and Start Assay
Medical Value Medical Value: Time to Result Is Crucial Cepheid GX System vs. Batch PCR and Culture Cepheid GX System Batch PCR Culture Articles that look at time to result as crucial to maximizing diagnostic value: 1. Lance R. Peterson, M.D., Donna M. Hacek, M.T. (A.S.C.P.), Ari Robicsek, M.D., Case Study: An MRSA Intervention at Evanston Northwestern Healthcare, printed in The Joint Commission Journal on Quality and Patient Safety Volume 33 Number 12, December 2007 2. Lance R. Peterson, M.D., Rapid Diagnosis of Community-Acquired MRSA, printed in Clinical Updates in Infectious Diseases, Volume Issue 3, October 2008 3. Eli N. Perencevich, MD, MS et al., SHEA Guideline: Raising Standards While Watching the Bottom Line: Making a Business Case for Infection Control, Infection Control and Hospital Epidemiology, Volume 28, Number 10, October 2007 0 12 24 48 Hours to Result 5 Cepheid
Uniquely Scalable: Low to High Throughputs Molecular Server Cabinet architecture enables system to grow with testing needs 6 Cepheid
Introducing the GeneXpert Omni 7 Cepheid Small and Portable Proven Cartridge Technology Durable Low Power Consumption Automatic Connectivity Solid State Integrated Battery Availability International: Q3 2017 US: 2018 GeneXpert Omni - The True Point of Care Mdx System
International United States Expanding on the Best-in-Class MDx Menu Available Now 2016 17 2018 19 2020 on CID Women s & Sexual Health 20 Tests US, 23 Tests ex-us MRSA Surveillance (NxG CE-IVD only) SA Nasal Complete C. Difficile (US only) & C. diff/epi Norovirus vana for VRE (US only) vana/b for VRE (CE-IVD only) MRSA/SA SSTI MRSA/SA BC Carba-R MTB/RIF EV Flu & Flu/RSV XC Flu/RSV CLIA Waived (US only) Ebola (CE-IVD & US EUA) CT (CE-IVD only) & CT/NG Trichomonas GBS & GBS Lim Broth (US only) HPV (CE-IVD only) MRSA Next Gen (2016) Carba-R Surv. (2016) Xpress Flu (2016) Xpress Flu CW Xpress Flu/RSV (2016) Xpress Flu/RSV CW Xpress Strep A Xpress Strep A CW Trichomonas (Male) (2016) HIV-1 Viral Load MTB Ultra (2016) Xpress Flu (2016) Xpress Flu/RSV (2016) Xpress Strep A HBV Viral Load 22 28 Xpress CT/NG Xpress CT/NG CW Xpress Vaginitis/Vaginosis Xpress Vaginitis/Vaginosis CW Xpress GBS Ultra HCV Viral Load HBV Viral Load Bladder CA Detection Bladder CA Monitor Breast CA Signature Xpress Vaginitis/Vaginosis Xpress GBS Ultra Xpress CT/NG Breast CA Signature 28 30 Carba-R Next Gen Syndromic Respiratory Panel Xpress Pertussis Xpress GBS Ultra CW CMV Pancreatic CA Early Detection Breast CA Monitor Prostate CA Early Detection EGFR Monitor (Lung) Lung CA Early Detection Virology Oncology & Genetics 8 Cepheid HIV-1 Qualitative (CE-IVD only) HIV-1 Viral Load (CE-IVD only) HCV Viral Load (CE-IVD only) BCR-ABL Ultra (CE-IVD, US RUO) FII & FV Bladder CA Detection (2016) Bladder CA Monitor (2016) Breast CA Stratifier (2016) Targeted Test Menu Subject to Revision, particularly in the 2020+ section. EUA = Emergency Use Authorization; RUO = Research Use Only Tests in Italics are Updates/Upgrades, and not included in the test count. This menu does not include any Omni targeted tests.
Cepheid C360 9 Cepheid
Cepheid C360 An Innovative Connectivity Solution Instrument Surveillance Aggregate and monitor instrument performance data Disease Surveillance Aggregate and monitor disease state testing data * Projected availability: Outside the U.S. 2H 2017; U.S. 2H 2018 10 Cepheid
Cepheid C360: Enhancing Productivity & Performance Secure Collection and Aggregation of Real-Time Information System Monitoring Disease Surveillance & Reporting Data Transmission Real-time visibility into system performance Monitoring of invalid rates, module calibration requirements, utilization Supports hub-andspoke models Enables proactive customer care Early detection and monitoring of outbreaks Identify at-risk populations Automated statutory reporting (e.g., CT/NG to CDC) Direct, real-time result communication for both clinician and patient Accelerates time to treatment 11 Cepheid
Cepheid C360 Potential Users 12 Cepheid
Xpert GBS for Intrapartum Group B Streptococci Detection 13 Cepheid
Xpert GBS Rapid Testing Upon Arrival Can Help Determine Appropriate Treatment Challenges Leading cause of neonatal morbidity and mortality Culture is time consuming Culture not an option for preterm births, women with no prenatal care or when results are unavailable (15 35% of births) Prophylactic antibiotics prescribed potential for increasing antibiotic resistance 32 Minutes* with Xpert GBS Ability to test mother upon arrival Timely information to determine appropriate treatment * With EAT (Early Assay Termination) for positive results Sources: MMWR Weekly; August 16, 2002; 1001.51; No. RR-11 14 Cepheid
15 Cepheid A Real Life Example: Meeting the Demands of the Modern Patient
Dean Street Express Clinic, London 1 Check In Get Tested Results within Hours 16 Cepheid 1. Photo material provided by Chelsea & Westminster Hospital NHS Foundation Trust, personal communication.
Proven Clinical Outcomes Faster Results: From 183 hours to 4 hours Quicker Treatment: 80% reduction in time to treatment Reduced Waiting Time: From 2 hours to 32 minutes Less Patients Lost to Follow-Up: From 3.8% to 1.2% For every 2 people diagnosed 1 partner spared exposure High Uptake: Monthly increase in testing ~600% Rated Excellent by 94% of users 1. Wingrove et al. Diagnostics within the clinic to test for gonorrhoea and chlamydia reduces the time to treatment: a service evaluation. Sex Transm Infect 2014;90: 474. 2. Dr. Alan McOwan. Dean Street Express. Data presented at the 2015 World STI & HIV Congress, Brisbane Australia. 17 Cepheid
One of the Biggest Global Health Care Problems of Our Time 18 Cepheid A post-antibiotic era means, in effect, an end to modern medicine as we know it. Margaret Chan, Director General, WHO
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