Sd Biosensor Patelki Bekasi 603v1l

Company Overview PT. BIONEER INDONESIA

Company Instruction

Veterinary diagnostics • Established in 2003 • Employees : 58

Human diagnostics • SD established in 1999 • Alere acquired SD in 2010 • SD BIOSESNOR Spin off fro m SD in 2010 • Employees : 163

Human genomic analysis • Established in 2015 • Employees : 13

Core Technologies Bio Contents development technology

Immunology Fluorescent ImmunoAssay - Quantitative FIA - Qualitative FIA Immuno-Chromatograpic Assay - Quantitative immunochromatograph y(MultiCare, HbA1c) - Qualitative immunochromatography( RDTs) ELISA

01

02

Recombinant Antigen - E. Coil - Baculo virus - HEK293 Antibody Antibody - Hybridoma, Phage display Protein Refolding Technology

04 Genomic New Biomarker development Electrochemistry & Dry chemistry Electrochemistry - Blood glucose monitoring system Dry-chemistry - Quantitative G6PD & Total Hb - Lipid

03

Newborn Screening Gene - Inborn error of Metablism - Immunologic Disorders - Hemoglobin Disorders Hereditary Cancer Gene - Breast Cancer, Ovarian Cancer - Endocrine Cancer - Gastrointestinal Cancer

Quantitative Analysis for Chronic disease

Electrochemistry & Dry chemistry

Electrochemistry

BGMS SD Check Gold SD CodeFree SD GlucoMentor SD GlucoNavii NFC SD GlucoNavii GDH

Quantitative ICT

MultiCare HbA1c CRP U-Albumin Lipid profile Vitamin D TSH

Dry chemistry

LipidoCare Lipid Profile Total cholesterol

SD G6PD

Quick Products Development that meets Market Needs

Product Portfolio of STANDARD

STANDARD F

Fluorescence Immunoassay Chronic diseases Vector-borne diseases Respiratory diseases

STANDARD Q

STANDARD E

Rapid Test

ELISA

Vector-borne diseases Blood- borne diseases Respiratory diseases STD

Denuge NS1 Dengue IgG Dengue IgM Zika IgM

38 Products Development in 2016 STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

Q HBsAg Q HCV Ab Q Malaria P.f Ag Q Malaria P.f/P.v Ag Q Malaria P.f/Pan Ag Q Malaria P.f/P.v Ab Q Syphilis Ag

STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

F PCT F CRP F U-Albumin F Legionella Ag F RSV Ag F Strep A Ag

STANDARD F200 Analyzer STANDARD E TB-Feron ELISA STANDARD Q HIV/Syphilis Combo STANDARD F S.pneumoniae Ag SD G6PD

STANDARD Q Dengue Duo STANDARD Q Dengue NS1 STANDARD Q Dengue IgM/IgG

Jan

Feb

Mar

Apr

SD MultiCare Anlayzer SD MultiCare CRP SD MultiCare U-Albumin

May

June

July

STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

Aug

Sep

Oct

Q HIV 1/2 Ab Q Legionella Ag Q S.pneumoniae Ag Q RSV Ag Q Strep A Ag E Zika IgM ELISA F100 Analyzer F HbA1c STANDARD F Influenza A/B STANDARD STANDARD STANDARD STANDARD STANDARD

Nov

Q Influenza A/B Q Zika IgM/IgG Q Dengue/Zika Trio E Dengue NS1 Ag ELISA E Dengue IgM ELISA E Dengue IgG ELISA

Dec

Products with Equivalent or Better performance than Existing Products

Competitiveness of STANDARD Fluorescent Immunoassay

Zika RDT kit

TB-Feron ELISA 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 STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

Q Chikungunya IgM/IgG Q Chikungunya Ag Q Rota/Adeno Ag Q FOB Q Salmonella typhi IgM/IgG Q TnI/CK-MB Duo E Chikungunya IgM ELISA E Chikungunya IgG ELISA E Chikungunya E1 ELISA F Dengue NS1 Ag F HCV Ab F HIV 1/2 Ab

STANDARD STANDARD STANDARD STANDARD

1Q

STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

Q TB MPT64 Q Noro Ag Q C.difficile toxin A/B/GDH Q Filariasis Ag Q Brucella IgM/IG Q Cholera Ag O1/O139 Q Hantaan virus Ab Q HIV Ag/Ab Q HCV cAg Q hs-Malaria Ag Q M.pneumoniae Ag Q Giardia/Cryptosporidium

F HBsAg F Vitamin D F hsCRP F TnI

2Q

STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

F Chikungunya E1 Ag F HCV cAg F HIV p24 Ag F C.difficile A/B/GDH F M.pneumoniae Ag F Dengue IgM/IgG F Zika IgM/IgG F Chikungunya IgM/IgG F TSH F Cystatin C F PSA F CK-MB F D-dimer

STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

3Q

Q R.typhi Q Leishumania IgM/IgG Q Chagas IgM/IgG Q JEV Ab Q HAV IgM/IgG Q Rubella IgM/IgG Q Leptospira Ab Q Tsutsugamushi Ab Q H.pylori Ag & Ab Q Anti-HBs F Filariasis Ag F Anti-HBs

STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD STANDARD

F HAV Ab F Adeno/Rota F TB MPT64 Ag F T4 F BNP F proBNP F AFP

4Q

STANDARD M Vector-borne pathogens kit(Zika virus, CHIKV, DENV 1,2,3,4) STANDARD M MERD-CoV kit STANDARD M Respiratory kit(Inf A, Inf B, RSV A/B)

Prepare for the Future POC NAT

Genetic Analysis

Responding to changes in

One step (no preparation)

Human genomic analysis

existing markets

Multiplex

Newborn Screening Gene

Result in 30 minutes

Hereditary Cancer Gene

High Sensitive Malaria

To be a

GAME CHANGER with

STANDARD

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 Lateral flow assay

Simple 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 1.0

106

0.9

peak viral load

Symptoms score

0.8 104 0.7

Low false negative results in early and convalescence phase of illness

area under the viral load curve

Viral decay rate 0.6

102

0.5 0.4

Infection duration

0.3

•

1

The sensitivity of STANDARD F is as high as chemiluminescent instruments.

initial viral growth rate, generation time

0.2 0.1

10-2 0

1

Influenza A

2 time to peak viral load

3

4

5

6 time(days)

Influenza B

ICT PFU/ml

1

310,000

+

2

31,000

+

3

3,100

4

ICT

STANDARD F

22,000

+

+

2

2,200

+

+

3

220

-

+

4

22

-

+

5

11

-

+/-

6

6

-

-

PFU/ml

+

1

+

-

+

310

-

+

5

155

-

+

6

78

-

+

7

39

-

+/-

8

19

-

-

x1,000

No.

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

x200

No.

STANDARD F

Source : Internal evaluation data.

0.0

Symptoms score

•

STANDARD F has lower limit of detection than conventional lateral flow products

viral load

•

Viral road

Competitive Advantage 2 Easy to operate Internal Quality Control

Calibration sets

Internal quality control

• Provides Calibration sets to check optical part of analyze • consists of 3 Calibration devices • Cal-1 for white calibration • Cal-2 for UV sensor • Car-3 for RGB sensor

• Each Qualitative test device package contains one positive and one negative control swab • For Quantitative test, Control solution is provided separately • this control swab is used to check that the analyzer and the test device are working together as a system

QC and calibration modes • Provides Quality Control reports • Automatic warning every 30 days to perform calibration

Competitive Advantage 3 Two Test Modes for Difference Situations

“ STANDARD TEST Mode ” The best way for automatic test

6

Test/hour

“ READ ONLY Mode ” The best way for numerous tests

240

Tests /hour

Competitive Advantage 4 Enhanced usability

Print out the test result with your handwriting on the test device

Easily save the operators and patients’ information by barcode reader

Competitive Advantage 5 Connectivity

Cloud server

STANDARD F 

F100

Data Transfer        

ID Patient ID Test results and test item Test error information GPS information LOT & Device information Serial number Consumed test quantity

Program Management  



Real time data collection and statistic analysis Efficient stock counting (enhanced supply chain management) Immediately response to remove the gap for the successful for the program management

STANDARD F Analyzers Portable

Small bench top

tests

High throughput

F100 Analyzer

F200 Analyzer

F400 Analyzer

F2400 Analyzer

Features

Test Method

Fluorescent immunoassay

Analysis

Quantitative & Qualitative

Test capacity

1 test each

1 test each

4 test simultaneously

70 Tests per hour Random access

Strip code recognition

2D Barcode

2D Barcode

2D Barcode

2D Barcode

Data storage

1,000

1,000

Connectivity

• Indirect LIS/HIS(USB cable) • Bluetooth dongle

• Direct LIS/HIS(Lan cable) • HL7 v2.6(PCD-01) • POCT1-A

• Direct LIS/HIS(Lan cable) • HL7 v2.6(PCD-01) • POCT1-A

• Direct LIS/HIS(Lan cable) • HL7 v2.6(PCD-01) • 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

Power

Battery(AA x 4) or AC/DC adapter

AC/DC adapter

AC/DC adapter

Power Cable (SMPS adapted)

Dimension(mm)

105 x 135 x 100

200 x 240 x 205

Weight

600g

2.7kg

3,000

400 x 500 x 250

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

Total-WB STANDARD F CRP (mg/L)

• • •

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

200.0

y = 0.9974x + 0.0579 R² = 0.9965

150.0

Slope

0.9979

Y-intercept

0.1286

R2

0.9966

n

120

Slope

0.9974

Y-intercept

0.0579

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)

Total-serum STANDARD F CRP (mg/L)

•

150.0

y = 0.9979x + 0.1286 R² = 0.9966

100.0 50.0 0.0 0.0

20.0

40.0

60.0

80.0

100.0

Refernece Method (mg/L)

120.0

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  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)

• • •

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

Test method

Dengue IgG

Zika IgM

Zika IgG

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 HbA1c/ CRP/ U- Albumin • Under developing : Vit D / LPD / TSH

Fast and simple test procedure 3 – 5 minutes assay time Minimal training required

Room temperature storage condition Battery powered portable analyzer Most suitable for making a decision at the point of care

Wide range of storage temperature of test (1 – 30 ºC/ 34- 86 ºF) *CRP : 2-8°C / 36-46°F

Specification – Test Kits HbA1c

CRP

U-Albumin

Whole blood

Whole blood, Serum, Plasma

Urine

Measurement Range

4.0~15.0%

Whole blood: 8 – 150mg/L Serum & Plasma: 5 - 120mg/L

5~300mg/L

Sample Volumes

5㎕

5㎕

3㎕

Testing Times

3 minutes

Whole blood: 5 minutes Serum & Plasma: 3 minutes

3 minutes

Storage temperature

1 – 30 ºC/ 34- 86 ºF

2-8°C / 36-46°F

1 – 30 ºC/ 34- 86 ºF

Sample

In development Lipid Profile Completion time

2017. 2Q

Vitamin-D 2017. 3Q

TSH 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