1. A BLOOD PROTEIN MARKER FOR THE EARLY
DETECTION OF PRE- ECLAMPSIA
A G7 DIAGNOSTICS PRESENTATION
Helena Gwani
Ayotunde Awosusi
Daniel Igwe
Priyesh Waghmare
Srishti Jain
Vinie Varkey T

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. Pre- Eclampsia
Globally, Causes: Symptoms:
•10% of all •Damage to the •Rising High blood
pregnancies blood vessels pressure
•Insufficient blood •High protein levels
•12% of maternal
flow to the uterus in the urine
deaths
•Severe headache
•1/3rd of pre mature
births •Visual Disturbances
•Vomiting and
abdominal pain

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. CAUSES OF MATERNAL DEATH

6. GLOBAL MATERNAL MORTALITY

7. PRE-ECLAMPSIA DISTRIBUTION (EXTRAPOLATED
FIGURES)
Source: http://www.cureresearch.com/p/preeclampsia/stats-country.htm

8. CURRENT DIAGNOSIS
Method Description Limitations
Blood pressure (>140/90) • Time consuming
Protein concentration in urine (>300mg/dL) •Complex
•Low reliability
Blood tests: liver, kidneys, platelets
number. •Late diagnosis
•Rate of false
Uterine artery Doppler ultrasound positive result is
high.

9. HOW CAN WE APPROACH THE PROBLEM?
 The ideal Screening test:
 Simple
 Noninvasive
 Rapid
 Inexpensive
 Early detection
 Highly sensitivity & predictive

10. MARKET NEED
12% of maternal deaths Global prevalence of pre-eclampsia
Our 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. 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.  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
Preeclampsia
1. sflt-1 (Soluble fms- like -- high Early increase
tyrosine kinase)
2. Soluble Endoglin (sEng) -- high Early increase
3. Placental Growth Factor low low further decrease
(PlGF)

13. Sample Port Blood Filter
Cells are
separated from
Reaction plasma
Chamber
A small fraction of
the 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. G7 PRE-ECLAMPSIA DIAGNOSTIC DEVICE

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. REPRODUCIBILITY
Reading system Automated
Reproducibility near 95%
clinical threshold
TEST PROCEDURE
Number of timed steps One step
Time to result 15 minutes

17. SAMPLING
Volume of sample 550µL
required
Throughput 90 tests
ADDITIONAL 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. 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. SCIENTIFIC EVIDENCE
 Nanoparticle based protein estimation:
 Jiang et al (2009)
 He et al (2010)

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. THANK YOU!

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. MOST RECENT – ALERE
 This technique uses immuno fluorescence.
 It is based on the PlGF marker
 Launched in Europe in January 2011.

24. PRODUCT SPECIFICATION