A blood protein marker for the early detection of pre- eclampsia

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A blood protein marker for the early detection of pre- eclampsia

  1. 1. A BLOOD PROTEIN MARKER FOR THE EARLYDETECTION OF PRE- ECLAMPSIA A G7 DIAGNOSTICS PRESENTATION Helena Gwani Ayotunde Awosusi Daniel Igwe Priyesh Waghmare Srishti Jain Vinie Varkey T
  2. 2. OUTLINE Pre- eclempsia: What is it? Causes of maternal death Global maternity mortality Pre-eclempsia distribution Current diagnosis Market need Product specifications Conclusion
  3. 3. Pre- EclampsiaGlobally, Causes: Symptoms:•10% of all •Damage to the •Rising High bloodpregnancies blood vessels pressure •Insufficient blood •High protein levels•12% of maternal flow to the uterus in the urinedeaths •Severe headache•1/3rd of pre maturebirths •Visual Disturbances •Vomiting and abdominal pain
  4. 4. RISK FACTORS  Medical problems  First time pregnancy  Family history  Previous case of pre-eclampsia  40 years or older  Obesity  Multiple birth Source: http://jalesknowsbabiesrock.blogspot.com/2010/10/annotated- webliography-of-preeclampsia.html
  5. 5. CAUSES OF MATERNAL DEATH
  6. 6. GLOBAL MATERNAL MORTALITY
  7. 7. PRE-ECLAMPSIA DISTRIBUTION (EXTRAPOLATEDFIGURES) Source: http://www.cureresearch.com/p/preeclampsia/stats-country.htm
  8. 8. CURRENT DIAGNOSISMethod Description LimitationsBlood pressure (>140/90) • Time consumingProtein concentration in urine (>300mg/dL) •Complex •Low reliabilityBlood tests: liver, kidneys, plateletsnumber. •Late diagnosis •Rate of falseUterine artery Doppler ultrasound positive result is high.
  9. 9. HOW CAN WE APPROACH THE PROBLEM? The ideal Screening test:  Simple  Noninvasive  Rapid  Inexpensive  Early detection  Highly sensitivity & predictive
  10. 10. MARKET NEED12% of maternal deaths Global prevalence of pre-eclampsiaOur market research reveals: There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or high-risk populations.
  11. 11. PRODUCT SPECIFICATIONS Intended uses of the test: early detection pre-eclempsia Target population/patient: Pregnant women (first trimester) Health facility where the test will be used: clinics, health centers and hospitals
  12. 12.  Biomarker:  A biological indicator whose presence, absence or abnormal concentration reflects the severity or presence of a disease.S.No. Biochemical Marker Plasma Concentration Manifest Trimester 1 Trimester 2 Preeclampsia1. sflt-1 (Soluble fms- like -- high Early increase tyrosine kinase)2. Soluble Endoglin (sEng) -- high Early increase3. Placental Growth Factor low low further decrease (PlGF)
  13. 13. Sample Port Blood Filter Cells are separated from Reaction plasma Chamber A small fraction ofthe Plasma sample Timegate mixes with the dried reagents Hyrdrophobic surface – ensures Three Internal Controls reaction time Independent Positive High – and low – control Assay Zones zones and a nonspecific binding Fluoroscent control tagged antibodies on Waste nano particles Reservoir are captured Excess sample collected in the on separate periphery zones
  14. 14. G7 PRE-ECLAMPSIA DIAGNOSTIC DEVICE
  15. 15. PRIORITY FEATURES Target molecule •Placental Growth Factor(PlGF), •Soluble Isoforms of flt-1 (sflt-1), •Soluble Endoglin (sEng) Sensitivity 94.5% Specificity 95% Type of analysis Nano particles based Fluoro- Immuno Assay (FIA) Reading system Automated Sample type Blood
  16. 16. REPRODUCIBILITY Reading system Automated Reproducibility near 95% clinical thresholdTEST PROCEDURE Number of timed steps One step Time to result 15 minutes
  17. 17. SAMPLING Volume of sample 550µL required Throughput 90 testsADDITIONAL CHARACTERISTICS Heat stability 15°C- 30°C Storage conditions 20°C End user profile Can be guided by the manual Bio-safety requirement Low Shelf-life of Disposable strip reagents/device Training needs No training required
  18. 18. CONCLUSIONS The product is superior compared to the existing technologies for the detection of pre- eclempsia:  Three independent biomarkers increase reliability of result  Automated A Point of Care approach Huge market demand
  19. 19. SCIENTIFIC EVIDENCE Nanoparticle based protein estimation:  Jiang et al (2009)  He et al (2010)
  20. 20. REFERENCES: Jiang, X., Weise, S., Hafner, M., Röcker, C., Zhang, F., Parak, W.J. and Nienhaus, G. U. (2009) Quantitative analysis of the protein corona on FePt nanoparticles formed by transferrin binding J R Soc Interface 7, S5-S13 He, Y., Li, Y. and Hun, X. (2010) Polymer nanoparticles as fluorescent labels in a fluoroimmunoassay for human chorionic gonadotropin Microchimica Acta 171:393–398
  21. 21. THANK YOU!
  22. 22. SCREENING TESTS AND THEIR LIMITATIONS Current Diagnosis  Measuring  blood pressure (>140/90)  protein concentration in urine (>300mg/dL)  Blood tests: liver, kidneys, platelets number.  Uterine artery Doppler ultrasound  Non stress test or biophysical profile:  Check if baby is getting sufficient O2 and nutrients  Response of baby’s heart rate relative to baby’s movement Limitations :  Time Consuming  Tendency of false positive result is high
  23. 23. MOST RECENT – ALERE This technique uses immuno fluorescence. It is based on the PlGF marker Launched in Europe in January 2011.
  24. 24. PRODUCT SPECIFICATION

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