Company Overview

PT. BIONEER INDONESIA

Company Instruction

Veterinary diagnostics Human diagnostics Human genomic analysis

• Established in 2003 • SD established in 1999 • Established in 2015

• Employees : 58 • Alere acquired SD in 2010 • Employees : 13
• SD BIOSESNOR Spin off fro
m SD in 2010
• Employees : 163
Core Technologies
Bio Contents
Immunology development technology
Fluorescent ImmunoAssay Recombinant Antigen
- Quantitative FIA 01 - E. Coil
- Qualitative FIA - Baculo virus
Immuno-Chromatograpic Assay - HEK293 Antibody
- Quantitative immunochromatograph Antibody
y(MultiCare, HbA1c) - Hybridoma, Phage display
- Qualitative immunochromatography( Protein Refolding Technology
RDTs) 02
ELISA

04
Genomic New Biomarker
development
Electrochemistry Newborn Screening Gene Panel
& Dry chemistry 03 - Inborn error of Metablism
- Immunologic Disorders
Electrochemistry - Hemoglobin Disorders
- Blood glucose monitoring system Hereditary Cancer Gene Panel
Dry-chemistry - Breast Cancer, Ovarian Cancer
- Quantitative G6PD & Total Hb - Endocrine Cancer
- Lipid - Gastrointestinal Cancer
Quantitative Analysis
for
Chronic disease
Electrochemistry & Dry chemistry

Electrochemistry Quantitative ICT Dry chemistry

BGMS MultiCare LipidoCare

SD Check Gold HbA1c Lipid Profile
SD CodeFree CRP Total cholesterol
SD GlucoMentor U-Albumin
SD GlucoNavii NFC Lipid profile
SD G6PD
SD GlucoNavii GDH Vitamin D
TSH
Quick Products Development
that meets Market Needs
Product Portfolio of STANDARD

STANDARD F STANDARD Q STANDARD E

Fluorescence
Rapid Test ELISA
Immunoassay
Chronic diseases Vector-borne diseases Denuge NS1
Vector-borne diseases Blood- borne diseases Dengue IgG
Respiratory diseases Respiratory diseases Dengue IgM
STD Zika IgM
38 Products Development in 2016
STANDARD Q HBsAg STANDARD F200 Analyzer
STANDARD F PCT
STANDARD Q HCV Ab STANDARD E TB-Feron ELISA
STANDARD F CRP
STANDARD Q Malaria P.f Ag STANDARD F U-Albumin
STANDARD Q Malaria P.f/P.v Ag STANDARD F Legionella Ag STANDARD Q HIV/Syphilis Combo
STANDARD Q Malaria P.f/Pan Ag STANDARD F RSV Ag STANDARD F S.pneumoniae Ag
STANDARD Q Malaria P.f/P.v Ab STANDARD F Strep A Ag SD G6PD
STANDARD Q Syphilis Ag

STANDARD Q Dengue Duo

STANDARD Q Dengue NS1
STANDARD Q Dengue IgM/IgG

Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec

STANDARD Q HIV 1/2 Ab

STANDARD Q Legionella Ag
STANDARD Q S.pneumoniae Ag
STANDARD Q RSV Ag
STANDARD Q Strep A Ag
STANDARD E Zika IgM ELISA
STANDARD F100 Analyzer
STANDARD F HbA1c
SD MultiCare Anlayzer STANDARD Q Influenza A/B
STANDARD F Influenza A/B
SD MultiCare CRP STANDARD Q Zika IgM/IgG
SD MultiCare U-Albumin STANDARD Q Dengue/Zika Trio
STANDARD E Dengue NS1 Ag ELISA
STANDARD E Dengue IgM ELISA
STANDARD E Dengue IgG ELISA
Products with Equivalent
or Better performance
than Existing Products
Competitiveness of STANDARD
Fluorescent TB-Feron ELISA
Zika RDT kit
Immunoassay Chikungunya IgM/IgG

Combination of the simplicity of Ability to react quickly to Product development that meets
RDTs and the accuracy of emergency situations such as the market needs
Molecular diagnostics Zika outbreak
Development Plan
63 Products will be developed in 2017
STANDARD Q Chikungunya IgM/IgG STANDARD F HBsAg STANDARD Q R.typhi STANDARD F HAV Ab
STANDARD Q Chikungunya Ag STANDARD F Vitamin D STANDARD Q Leishumania IgM/IgG STANDARD F Adeno/Rota
STANDARD Q Rota/Adeno Ag STANDARD F hsCRP STANDARD Q Chagas IgM/IgG STANDARD F TB MPT64 Ag
STANDARD Q FOB STANDARD F TnI STANDARD Q JEV Ab STANDARD F T4
STANDARD Q Salmonella typhi IgM/IgG STANDARD Q HAV IgM/IgG STANDARD F BNP
STANDARD Q TnI/CK-MB Duo STANDARD Q Rubella IgM/IgG STANDARD F proBNP
STANDARD E Chikungunya IgM ELISA STANDARD Q Leptospira Ab STANDARD F AFP
STANDARD E Chikungunya IgG ELISA STANDARD Q Tsutsugamushi Ab
STANDARD E Chikungunya E1 ELISA STANDARD Q H.pylori Ag & Ab
STANDARD F Dengue NS1 Ag STANDARD Q Anti-HBs
STANDARD F HCV Ab STANDARD F Filariasis Ag
STANDARD F HIV 1/2 Ab STANDARD F Anti-HBs

1Q 2Q 3Q 4Q

STANDARD Q TB MPT64 STANDARD F Chikungunya E1 Ag

STANDARD Q Noro Ag STANDARD F HCV cAg STANDARD M Vector-borne pathogens kit(Zika virus, CHIKV,
STANDARD Q C.difficile toxin A/B/GDH STANDARD F HIV p24 Ag DENV 1,2,3,4)
STANDARD Q Filariasis Ag STANDARD F C.difficile A/B/GDH STANDARD M MERD-CoV kit
STANDARD Q Brucella IgM/IG STANDARD F M.pneumoniae Ag STANDARD M Respiratory kit(Inf A, Inf B, RSV A/B)
STANDARD Q Cholera Ag O1/O139 STANDARD F Dengue IgM/IgG
STANDARD Q Hantaan virus Ab STANDARD F Zika IgM/IgG
STANDARD Q HIV Ag/Ab STANDARD F Chikungunya IgM/IgG
STANDARD Q HCV cAg STANDARD F TSH
STANDARD Q hs-Malaria Ag STANDARD F Cystatin C
STANDARD Q M.pneumoniae Ag STANDARD F PSA
STANDARD Q Giardia/Cryptosporidium STANDARD F CK-MB
STANDARD F D-dimer
Prepare for the Future
High Sensitive Malaria POC NAT Genetic Analysis

To be a

GAME
CHANGER
with

STANDARD

Responding to changes in One step (no preparation) Human genomic analysis

existing markets Multiplex Newborn Screening Gene Panel
Result in 30 minutes Hereditary Cancer Gene Panel
Manufacturing Capacity

FIA devices RDT strips Glucose strips Lipid strips

50 145 1.4 14
Million Tests Million Tests Billion Tests Million Tests
STANDARD F
Fluorescent Immunoassay(FIA)

• Fluorescent Immunoassay is a different

type of immunoassay.

• The fluorescent beads enable highly

sensitive detection of the target analytes,
antigens and antibodies.

• Simple lateral flow assay with a powerful

but low cost analyzer like a STANDARD F
improves assay performance.
Why STANDARD F?

Fluorescent Immunoassay Simple

Lateral flow assay analyzer

Rapid, Objective, Accurate.

Simple analyzers accurately reads and interprets lateral flow tests in just seconds, delivering
automated, objective results in any healthcare setting
Competitive Advantage 1
200 times more sensitive than ICT
106 1.0
Viral road
• STANDARD F has lower limit of peak viral load 0.9
Symptoms score
detection than conventional 0.8
104
lateral flow products 0.7
area under Viral decay rate

Symptoms score
the viral load 0.6
• Low false negative results in

viral load
curve
102 0.5
early and convalescence phase
0.4
of illness Infection
duration
0.3
1
• The sensitivity of STANDARD F initial viral growth
rate, generation
0.2

is as high as chemiluminescent time 0.1

instruments. 10-2 0.0

0 1 2 3 4 5 6
time to peak viral load time(days)

Influenza A Influenza B
ICT STANDARD F ICT STANDARD F
No. PFU/ml No. PFU/ml

1 310,000 + + 1 22,000 + +

2 31,000 + + 2 2,200 + +

x200
3 3,100 - + 3 220 - +
x1,000

4 310 - + 4 22 - +

5 155 - + 5 11 - +/-

6 78 - + 6 6 - -

7 39 - +/- Source : Internal evaluation data.

8 19 - -

Source : * Rapid Diagnostic Testing for Influenza: Information for Health Care Professionals. CDC.
American Journal of Epidemiology, Time lines of infection and disease in human influenza: A review of volunteer challenge studies
Competitive Advantage 2
Easy to operate Internal Quality Control

Calibration sets Internal quality control QC and calibration modes

• Provides Calibration sets to • Each Qualitative test device • Provides Quality Control reports
check optical part of analyze package contains one positive • Automatic warning every 30 days
• consists of 3 Calibration devices and one negative control swab to perform calibration
• Cal-1 for white calibration • For Quantitative test, Control
• Cal-2 for UV sensor solution is provided separately
• Car-3 for RGB sensor • this control swab is used to check
that the analyzer and the test
device are working together as a
system
Competitive Advantage 3
Two Test Modes for Difference Situations

“ STANDARD TEST Mode ” “ READ ONLY Mode ”

The best way for automatic test The best way for numerous tests

6 Test/hour 240 Tests /hour

Competitive Advantage 4
Enhanced usability

Easily save the operators and

Print out the test result with your
patients’ information by barcode
handwriting on the test device
reader
Competitive Advantage 5
Connectivity

Cloud
server

STANDARD F Data Transfer Program Management

 F100  User ID  Real time data collection and
 Patient ID statistic analysis
 Test results and test item  Efficient stock counting (enhanced
 Test error information supply chain management)
 GPS information  Immediately response to remove the
 LOT & Device information gap for the successful for the
 Serial number program management
 Consumed test quantity
STANDARD F Analyzers
Portable Small bench top Panel tests High throughput

Features

F100 Analyzer F200 Analyzer F400 Analyzer F2400 Analyzer

Test Method Fluorescent immunoassay

Analysis Quantitative & Qualitative

70 Tests per hour

Test capacity 1 test each 1 test each 4 test simultaneously
Random access
Strip code
2D Barcode 2D Barcode 2D Barcode 2D Barcode
recognition
Data storage 1,000 1,000 3,000

• Direct LIS/HIS(Lan cable) • Direct LIS/HIS(Lan cable) • Direct LIS/HIS(Lan cable)

• Indirect LIS/HIS(USB cable)
Connectivity • HL7 v2.6(PCD-01) • HL7 v2.6(PCD-01) • HL7 v2.6(PCD-01)
• Bluetooth dongle
• POCT1-A • POCT1-A • POCT1-A

Display Graphic LCD 7” Color Touch Screen 7” Color Touch Screen 7” Color Touch Screen

Printer External Built-in Built-in Built-in

Battery(AA x 4) or Power Cable

Power AC/DC adapter AC/DC adapter
AC/DC adapter (SMPS adapted)

Dimension(mm) 105 x 135 x 100 200 x 240 x 205 400 x 500 x 250

Weight 600g 2.7kg

STNADARD F
Clinical Evaluation
Clinical Evaluation – HbA1c
• The evaluation shows a strong correlation between STANDARD F and reference method
with correlation coefficient of 0.99
• Testing site : Internal evaluation
• Reference : HLC-723 GX (Tosoh)
• Specimen : 80 Venous specimen

Slope 0.9628
Y-intercept 0.2768
R2 0.9906
n 80
Clinical Evaluation – Urine Albumin
• The evaluation shows a strong correlation between STANDARD F and reference method
with correlation coefficient of 0.99
• Testing site : Internal evaluation
• Reference : HITACHI 7020
• Specimen : 210 Urine specimens

Slope 0.9941
Y-intercept 0.2120
R2 0.9983
n 210
Clinical Evaluation – PCT
• The evaluation shows a strong correlation between STANDARD F and reference method
with correlation coefficient of 0.99
• Testing site : Internal evaluation
• Reference : Roche cobas e 411
• Specimen : 70 serum specimens

Slope 0.9942
Y-intercept 0.0158
R2 0.9866
n 70
Clinical Evaluation – CRP
• The evaluation shows a strong correlation between STANDARD F and reference method
with correlation coefficient of 0.99
• Testing site : Internal evaluation
• Reference : HITACHI 7020
• Specimen : 120 WB specimens / 120 Serum specimens
Slope 0.9979
Total-WB
Y-intercept 0.1286
200.0
R2
STANDARD F CRP (mg/L)

y = 0.9974x + 0.0579
0.9966
150.0
R² = 0.9965 n 120
100.0

50.0

0.0
0.0 50.0 100.0 150.0 200.0
Refernece Method (mg/L)

Slope 0.9974
Total-serum
Y-intercept 0.0579
150.0
STANDARD F CRP (mg/L)

y = 0.9979x + 0.1286
R2 0.9965
100.0 R² = 0.9966 n 120

50.0

0.0
0.0 20.0 40.0 60.0 80.0 100.0 120.0
Refernece Method (mg/L)
STANDARD Q
( Rapid Diagnostic
Kit )
STANDARD Q
Clinical Evaluation

Syphilis Ab
Syphilis Ab ( E-Catalog Listing )

STANDARD Q Syphilis Ab

• Fast test result: 5mins

• Convenient storage condition: 2-40°C / 36-104°F
• Specimen : Serum/Plasma/Whole blood
• Specimen volume : 20µl(Whole blood)
10µl(Serum/Plasma)
• Sensitivity : 100% (41/41)
• Specificity : 97.5% (158/162)
Test Procedure – Syphilis Ab
Clinical Evaluation – 1
<Information>

 The performance evaluation was conducted by

Ministry of Health Kamuzu Central Hospital in
Malawi
 Number of Positive samples : 20
 Number of Negative samples : 20
 Reference Method : Rapid Immuno-Chromatography
method
 Sample Volume(Type) : 10µl(Serum/Plasma),
20µl(Whole Blood)

<Conclusion>

• Sensitivity : 100% (20/20)

• Specificity : 100% (20/20)
• STANDARD Q Syphilis Ab Test is performing well
against the competitor
STANDARD Q
Clinical Evaluation

Dengue
Dengue

STANDARD Q Dengue Duo

• Deteksi IgG-IgM dan NS1
• Sen : 95%
• Spe : 100
• Specimen : Seru/Plasma/WB%

STANDARD Q Dengue NS1 Ag

• Fast test result: 15mins

• Specimen : Serum/Plasma/Whole blood
• Specimen volume : 100 µl
• Sensitivity : 92.9% (184/198) / Specificity : 98.7% (222/225)

STANDARD Q Dengue IgM/IgG

• Fast test result: 15mins

• Specimen : Serum/Plasma/Whole blood
• Specimen volume : 10 µl
• IgM - Sensitivity : 97.5% (77/79) / Specificity : 96.6% (346/358)
• IgG - Sensitivity : 97.2% (140/144) / Specificity : 96.2% (282/293)
Malaria

STANDARD Q Malaria P.f Ag

• Fast test result: 15mins
• Specimen : Whole blood
• Specimen volume : 5 µl
• Sensitivity : 98.4% (126/128) / Specificity : 97.5% (234/240)

STANDARD Q Malaria P.f/P.v Ag

• Fast test result: 15mins
• Specimen : Whole blood
• Specimen volume : 5 µl
• Sensitivity : 99.64% (283/284)/ Specificity : 99.2% (256/258)

STANDARD Q Malaria P.f/Pan Ag

• Fast test result: 15mins
• Specimen : Whole blood
• Specimen volume : 5 µl
• Sensitivity : 98.72% (231/234)/ Specificity : 96.76% (209/216)
STANDARD E
ELISA – STANDARD E
Products Dengue NS1 Dengue IgM Dengue IgG Zika IgM Zika IgG

Test method Enzyme Liked Immunosorbent Assay

Specimen Serum/Plasma Serum/Plasma Serum/Plasma Serum/Plasma Serum/Plasma

Pack size 96 wells/kit 96 wells/kit 96 wells/kit 96 wells/kit 96 wells/kit

Sensitivity 181/198 (91.4%) 77/79 (97.4%) 140/144 (97.2%) 77/79 (97.4%) -

Specificity 221/225 (98.2%) 346/358 (96.6%) 282/293 (96.2%) 346/358 (96.6%) -

Store 2~8℃ / 36~46℉ 2~8℃ / 36~46℉ 2~8℃ / 36~46℉ 2~8℃ / 36~46℉ 2~8℃ / 36~46℉

Shelf life 15 months at 2~8℃ 15 months at 2~8℃ 15 months at 2~8℃ 15 months at 2~8℃ 15 months at 2~8℃
SD MultiCare
Major Benefit of MultiCare

6 tests on 1 analyzer Fast and simple test procedure

HbA1c/ CRP/ U- Albumin 3 – 5 minutes assay time
• Under developing Minimal training required
: Vit D / LPD / TSH

Room temperature storage condition

Wide range of storage temperature of test
Battery powered portable analyzer panel (1 – 30 ºC/ 34- 86 ºF)

Most suitable for making a decision *CRP : 2-8°C / 36-46°F

at the point of care
Specification – Test Kits
HbA1c CRP U-Albumin
Whole blood, Serum,
Sample Whole blood Urine
Plasma
Whole blood:
8 – 150mg/L
Measurement Range 4.0~15.0% 5~300mg/L
Serum & Plasma:
5 - 120mg/L

Sample Volumes 5㎕ 5㎕ 3㎕

Whole blood:
5 minutes
Testing Times 3 minutes 3 minutes
Serum & Plasma:
3 minutes

Storage temperature 1 – 30 ºC/ 34- 86 ºF 2-8°C / 36-46°F 1 – 30 ºC/ 34- 86 ºF

In development
Lipid Profile Vitamin-D TSH

Completion time 2017. 2Q 2017. 3Q 2017. 4Q

Bekasi Team

PT. BIONEER INDONESIA

Kontak : MILKE APRIYANI

HP : 0823-12-77-8669
BEKASI DISTRIBUTOR

PT. PRAMUDYA GLOBAL ANUGRAH

Kontak : Bobby Christian

HP : 0811- 10-94-716
 THANK YOU

TEAM PT.BIONEER INDONESIA