A Fully Automated Sample-to-result PCR System for Detecting Infectious Diseases

1. GeneReach Biotechnology Corporation
A Fully Automated Sample-to-result PCR
System for Detecting Infectious Diseases
Simon Chung
Chief Commercial Officer
GeneReach Biotechnology Corporation
Taiwan

2. GeneReach Biotechnology Corporation

3. GeneReach Biotechnology Corporation
Infectious diseases in Solomon Islands
Hepatitis
A
Hepatitis
B
Malaria
Typhoid
Dengue
TB
Zika
Yellow
fever

4. GeneReach Biotechnology Corporation
Mosquito transmitted diseases
Dengue
Zika
Chikungunya
Yellow fever
Malaria

5. GeneReach Biotechnology Corporation
Which pathogen infects you?
Dengue
Zika
Chikungunya
Yellow fever
Malaria

6. GeneReach Biotechnology Corporation
Introduction of POCKIT Central system
Fully automated with easy sample ID input
and data output
Modulized Nucleic acids extraction and
lyophilized PCR reagents

7. GeneReach Biotechnology Corporation
Traditional PCR iiPCR
heat
POCKIT
PCR in a simple heater
complicated mechanical modules
Principle of iiPCR
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8. GeneReach Biotechnology Corporation
Optic
collection
Digital Signal
Processing
Chip
LED
excitation
FAM (520 nm)
JOE/VIC (550 nm)
Fluorescent TaqMan
PCR reagent
Band-pass filter
Optical Fiber
Automatic Data interpretation process
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9. GeneReach Biotechnology Corporation
Principle of iiPCR

10. GeneReach Biotechnology Corporation
Specific detection of iiPCR

11. GeneReach Biotechnology Corporation
How POCKIT detects the result

12. GeneReach Biotechnology Corporation
The POCKIT device portfolio
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POCKIT 1.0
•Throughput: 1 - 8
•Detection channel: 1 - 2
•Run time: < 1 hour
•Dimensions: 310 (W) x 260 (D) x
150 (H) mm
•Weight: 2.1 kg
POCKIT Pro
•Throughput: 1 - 32
•Detection channel: 1 - 5
•Run time: < 1 hour
•Dimensions: 310 (W) x 260 (D) x 150
(H) mm
•Weight: 6 kg
POCKIT μ
•Throughput: 1 - 4
•Detection channel: 1 - 2
•Run time: < 1 hour
•Dimensions: 63 (W) x 152 (D) x 50
(H) mm
•Weight: 0.3 kg
•Powered by rechargeable battery
POCKIT Central
•Throughput: 1 - 8
•Extraction Included
•Run time: hands-on time less
than 5 min; total reaction time <
2 hour
•Detection channel: 1 - 2
•Dimensions: 300 (W) x 400 (D) x
500 (H) mm
•Weight : 25 kg

13. GeneReach Biotechnology Corporation
POCKIT Central reagent format
• Lyophilized format
• No cold chain is needed
for shipping
• Long shelf life- 2 years at
2-8°C
• Open-bag stability: 2-8°C
for 2 months or -20°C for 6
months

14. GeneReach Biotechnology Corporation
GeneReach and its quality system

15. GeneReach Biotechnology Corporation
Compliance of quality system
 Human medical device manufacturing process
Certification: OIE (2008, 2013)
ISO 13485:2003
GMP Factory

16. GeneReach Biotechnology Corporation
Certificates of ISO and GMP
ISO 13485:2003 GMP

17. GeneReach Biotechnology Corporation
Listed on
Biodetection
Tech. for First
Responders
Tested and
listed by PNNL,
USA in May
2015

18. GeneReach Biotechnology Corporation
POCKIT Combo and Micro

19. GeneReach Biotechnology Corporation
Collaboration and validation with
Tropical Medicine Center (TMC), Kaohsiung
Medicine University Hospital (KMUH)

20. GeneReach Biotechnology Corporation
Publication 2018

21. GeneReach Biotechnology Corporation
Publication 2017

22. GeneReach Biotechnology Corporation
Dengue subtyping reagents and validation

23. GeneReach Biotechnology Corporation
DENV iiPCR reagent/ POCKIT inclusivity target gene
analytical
sensitivity
exclusivity CE-IVD
POCKIT Dengue Virus Reagent Set
Dengue virus
serotype 1-4
3' UTR 6 copies
Zika virus, CHIKV,
WNV, YFV
yes
POCKIT Dengue Virus
Serotype 1 Reagent Set
Dengue virus
serotype 1
NS5 10 copies
Dengue virus
serotype 2,3,4
no
POCKIT Dengue Virus
Serotype 2 Reagent Set
Dengue virus
serotype 2
E 12 copies
Dengue virus
serotype 1,3,4
no
POCKIT Dengue Virus
Serotype 3 Reagent Set
Dengue virus
serotype 3
prM 13 copies
Dengue virus
serotype 1,2,4
no
POCKIT Dengue Virus
Serotype 4 Reagent Set
Dengue virus
serotype 4
prM 13 copies
Dengue virus
serotype 1,2,3
no
POCKIT Reagent Sets

24. GeneReach Biotechnology Corporation
Validation of POCKIT Dengue subtyping RT-iiPCR
reagents and POCKIT Central system
POCKIT Combo vs CDC rRT-PCR
• Analytical sensitivity
• Analytical specificity
• Clinical performance
POCKIT Central vs POCKIT Combo
• Analytical sensitivity
• Analytical specificity
• Clinical performance
equivalent to

25. GeneReach Biotechnology Corporation
Comparison of analytical sensitivity of DENV subtyping
RT-iiPCR on POCKIT Combo and CDC rRT -PCR
Reagent Pathogen Titer (PFU ml-1) qRT-PCR RT-iiPCR
POCKIT DENV-1 DENV-1
103 3/3 3/3
102 3/3 3/3
101 3/3 3/3
10-0 0/3 3/3
10-1
10-2
0/3
0/3
2/3
0/3
POCKIT DENV-2 DENV-2
103 3/3 3/3
102 3/3 3/3
101 3/3 3/3
10-0 3/3 3/3
10-1
10-2
2/3
0/3
0/3
0/3
POCKIT DENV-3 DENV-3
103 3/3 3/3
102 3/3 3/3
101 3/3 3/3
10-0 3/3 3/3
10-1
10-2
0/3
0/3
1/3
0/3
POCKIT DENV-4 DENV-4
103 3/3 3/3
102 3/3 33
101 3/3 3/3
10-0 0/3 3/3
10-1
10-2
0/3
0/3
1/3
0/3

26. GeneReach Biotechnology Corporation
Analytical specificity of DENV subtyping RT-iiPCR
on POCKIT Combo
Pathogen POCKIT DENV-1 POCKIT DENV-2 POCKIT DENV-3 POCKIT DENV-4
Dengue virus-1 + - - -
Dengue virus-2 - + - -
Dengue virus-3 - - + -
Dengue virus-4 - - - +
Zika virus - - - -
Chikungunya virus - - - -

27. GeneReach Biotechnology Corporation
POCKIT
qRT-PCR
Total (POCKIT)
Positive Negative
Positive 20 0 20
Negative 0 20 20
Total (qRT-iiPCR) 20 20 40
POCKIT Combo vs CDC rRT PCR (n = 40, 20 positive, 20 negative)
CI 95% = 93.7 ~ 100%, κ = 1.0
Clinical Performance
DENV-1

28. GeneReach Biotechnology Corporation
Clinical Performance
DENV-2
POCKIT
qRT-PCR
Total (POCKIT)
Positive Negative
Positive 19 1 20
Negative 0 20 20
Total (qRT-iiPCR) 19 21 40
POCKIT Combo vs CDC rRT PCR (n = 40, 20 positive, 20 negative)
CI 95% = 89.8 ~ 100%, κ = 0.95

29. GeneReach Biotechnology Corporation
Clinical Performance
DENV-3
POCKIT
qRT-PCR
Total (POCKIT)
Positive Negative
Positive 20 1 21
Negative 0 19 19
Total (qRT-iiPCR) 20 20 40
CI 95% = 89.8 ~ 97.5%, κ = 0.95
POCKIT Combo vs CDC rRT PCR (n = 40, 20 positive, 20 negative)

30. GeneReach Biotechnology Corporation
Clinical Performance
DENV-4
POCKIT
qRT-PCR
Total (POCKIT)
Positive Negative
Positive 20 0 20
Negative 0 20 20
Total (qRT-iiPCR) 20 20 40
POCKIT Combo vs CDC rRT PCR (n = 40, 20 positive, 20 negative)
CI 95% = 93.7 ~ 100%, κ = 1.0

31. GeneReach Biotechnology Corporation
DENV iiPCR reagent/Central inclusivity target gene exclusivity
POCKIT Central Dengue Virus Premix
Reagent Dengue virus serotype 1-4 3' UTR
Zika virus, CHIKV,
WNV, YFV
POCKIT Central Dengue Virus Serotype 1
Premix Reagent
Dengue virus serotype 1 NS5
Dengue virus
serotype 2,3,4
POCKIT Central Dengue Virus Serotype 2
Premix Reagent
Dengue virus serotype 2 E
Dengue virus
serotype 1,3,4
POCKIT Central Dengue Virus Serotype 3
Premix Reagent
Dengue virus serotype 3 prM
Dengue virus
serotype 1,2,4
POCKIT Central Dengue Virus Serotype 4
Premix Reagent
Dengue virus serotype 4 prM
Dengue virus
serotype 1,2,3
POCKIT Central Reagent

32. GeneReach Biotechnology Corporation
Validation of POCKIT Central Dengue Virus
Reagent and POCKIT Dengue Virus Reagent Set

33. GeneReach Biotechnology Corporation
Comparison of analytical Sensitivity of pan-DENV
RT-iiPCR/POCKIT Central (vs. POCKIT Combo)
Sample PUF/ml Combo POCKIT Central
DENV-1
103
3/3 3/3
102
3/3 3/3
101
3/3 3/3
10-0
0/3 3/3
10-1
0/3 0/3
DENV-2
103
3/3 3/3
102
3/3 3/3
101
3/3 3/3
10-0
3/3 2/3
10-1
10-2
0/3
0/3
1/3
0/3
DENV-3
103
3/3 3/3
102
3/3 3/3
101
3/3 3/3
10-0
2/3 3/3
10-1
10-2
0/3
0/3
1/3
0/3
DENV-4
103
3/3 3/3
102
3/3 3/3
101
3/3 3/3
10-0
1/3 2/3
10-1
0/3 0/3

34. GeneReach Biotechnology Corporation
Specificity of pan-DENV RT-iiPCR /POCKIT Central
Pathogen
pan-DENV RT-iiPCR/ POCKIT
Combo
pan-DENV RT-iiPCR/ POCKIT
Central
Dengue virus-1 + +
Dengue virus-2 + +
Dengue virus-3 + +
Dengue virus-4 + +
Zika virus - -
Chikungunya virus - -

35. GeneReach Biotechnology Corporation
Pan DENV RT-iiPCR test with Combo and Central system.
n = 60, 10 DENV-1 positive, 10 DENV-2 positive, 10 DENV-3 positive, 10 DENV-4 positive, 20 negative
POCKIT Central Dengue
Virus Premix Reagent
POCKIT Dengue Virus Reagent Set
Positive Negative Total
Positive 40 0 40
Negative 0 20 20
Total 40 20 60
CI 95% = 93.7 ~ 100%, κ = 1.0
Comparison of clinical performance

36. GeneReach Biotechnology Corporation
Comparison to other method
Competitor A
(i.e. Real-time 7500)
POCKIT Central
Sample throughput 96 1~8
Technology qPCR PCR
Automation NO YES
IVD certification US-IVD CE-IVD
Data interpretation Staff interpretation
Built-in algorithm for data
interpretation
Turnaround time 2 hours upon receiving the samples 85 mins after with draw the blood
Transportable No Yes
Instrument price Expensive Low (US 1599)
Reagent price Low ($20-30/test) Low ($10/test)
Country of origin US Taiwan

37. GeneReach Biotechnology Corporation
Applications of POCKIT Central System
Food Safety
IVD
Aquaculture
Companion
Animals
Livestock &
Poultry
Bio-security;
Surveillance program

38. GeneReach Biotechnology Corporation
Screening AIV at live bird market in Vietnam
38

39. GeneReach Biotechnology Corporation
Screening Avian Influenza Virus in Northern Vietnam by FAO
(Food and Agriculture Organization of United Nation)
Video

40. GeneReach Biotechnology Corporation
Deployed to each island

41. GeneReach Biotechnology Corporation
PCR detection for first responders
(Local Clinics)
tacomini Nucleic Acid
Extraction
POCKIT Micro Plus
PCR detection
25 mins 42 mins
POCKIT micro plus
tacomini

42. GeneReach Biotechnology Corporation
PCR detection for regional labs
(Island Hospitals)
DNA/RNA Extraction + PCR Detection
POCKIT Central
PCR detection
POCKIT Central
85 mins

43. GeneReach Biotechnology Corporation
PCR detection in central hospital
DNA/RNA Extraction PCR Detection
Nucleic Acid
Extraction
qPCR
detection
50 mins 90 mins

44. GeneReach Biotechnology Corporation
Smart detection for precision treatment

45. GeneReach Biotechnology Corporation
Quicker test results and proper treatment
DENV screening test DENV typing test

46. GeneReach Biotechnology Corporation
Precision typing the Dengue infection in 85 minutes
•DENV
•Type 1
•Type 2
•Type 3
•Type 4

47. GeneReach Biotechnology Corporation
POCKIT Central
POCKIT Central Video

48. GeneReach Biotechnology Corporation
Thank you for the attention
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