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PoC Quo Vadis?

PoC Quo Vadis?. “If you build it, will they come?” David S. Frank, P h . D. MED x Associates LLC. What is PoC Dx. A 100+ year romp. DSF Definition. The ability to access information in real-time Critical information that defines the state of health of the patient

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PoC Quo Vadis?

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  1. PoC Quo Vadis? “If you build it, will they come?” David S. Frank, Ph. D. MEDx Associates LLC

  2. What is PoC Dx A 100+ year romp

  3. DSF Definition The ability to access information in real-time Critical information that defines the state of health of the patient Information whose value depends on its timeliness (and accuracy)

  4. …beginning 100+ years ago • Auscultationis the term for listening to the internal sounds of the body, usually using a stethoscope. Auscultation is performed for the purposes of examining the circulatory systemand respiratory system and breath sounds • Electronic stethoscopescan provide noise reduction and signal enhancement. This is helpful for purposes of telemedicine (remote diagnosis) and teaching. Their availability opened the field to computer-aided auscultation.

  5. IVD PoC • Glucose level fluctuation in Type I (and Type II) diabetics • Urine tasting  • Urine testing  • Blood (self) testing  • Early models (1975) 30µL blood, 1-2 minutes, analog meter, ±20% • Current standard 0.3-0.5 µL, 5 seconds, digital meter with memory and Bluetooth, ±<10% • $9B Worldwide business

  6. Test Samples Whole Blood Plasma/Serum Urine Saliva Sweat Breath NONE

  7. Changes in Decentralized IVD Testing and the ACA The new law’s demands are reshaping laboratory strategies Keep pace with insights and observations on the evolving decentralized testing industry.  Conversations over the implications of the ACA continue, especially in the area of decentralized testing surrounding reimbursement, affordability and quality of care

  8. The Winners--Worldwide Non-instrumented Instrumented • SMBG + Professional • Lifescan • Roche • Abbott • Bayer • Pregnancy • Many • Breath Alcohol • Strep A Roche 17% iSTAT (Abbott) 7% Siemens 11% Triage (Alere) 24% Others 41% (DT-60 (J&J))

  9. The Losers Non-instrumented Instrumented Over 180 companies worldwide now offer products Vision (Abbott) 1980s

  10. Abbott iSTAT • 73% of US hospitals are using the Abbott i-STAT in some capacity • Nearly 3,000 i-STAT units found in this sample of 261 institutions; an average of just under 10 units per institution • 92% of institutions using the i-STAT are satisfied • with it’s performance • Chemistry testing is the most common use for the i-STAT • and also represents the largest overall volume, • over 1 million tests per year across the 257 respondent institutions • 17% of institutions are using the i-STAT • for only one type of testing • Very few respondents are using the i-STAT for CK-MB and BNP • Troponin – 28% of users • CK-MB – 3% of users • BNP – 6% of users

  11. Annual Usage on the iSTAT Average ~5000/Yr

  12. US Hospital PoC Change Over Time

  13. PoC Segments (Professional) Chemistry Glucose/HbA1c Coag Blood gas Co-oximetry Cardiac markers CF Sweat Bilirubin (pediatric) Hemoglobin/Hct Sepsis HIV Strep B Strep A Chlamydia Gonorrhea Malaria HCV Urinalysis

  14. Take Away Message • Make sure there is a REAL market need • Make sure there are no high barriers to entry (CLIA waived, Biologist (Fr)) • Make sure the product performs to meet the clinical need • Make sure the product can be manufactured at a cost to provide margin for multiple hands (inventor, manufacturer, distributor, dealer, user + taxes and duties)

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