Making

a Healthier Future
for Humanity
with BIONEER’s MDx

This material is prepared for the purpose of understanding BIONEER and its main business areas. Therefore, BIONEER is not responsible for investment decisions
etc. made based on this material. Also, it is prohibited to use, post and/or distribute part or all of this material without the expressed consent of BIONEER.
Copyright 2018, Bioneer Corporation. All rights reserved.
 Features of BIONEER’s MDx

▌ Who is BIONEER?

Based on integrated molecular technology,

We delivers TOTAL SOLUTION for MDx

Established

1992
1 Cooperation
1st Bio-venture with our partners Various MDx products
in Korea in approx. countries using own technologies
30

Innovation•Value•Discovery l BIONEER 2
Features of BIONEER’s MDx

▌ BIONEER’s MDx

BIONEER provides total solution of MDx

by integrated technologies

In-house
Various
MDx Raw
Diagnostic
System Material
Kits
Production

We guarantee of FULL RESPONSIBILITY for MDx

Innovation•Value•Discovery l BIONEER 3
Features of BIONEER’s MDx

▌ BIONEER’s MDx

Raw material
Raw MDx MDx
material system kits MDx system
MDx Kits

Company A Company B Company C BIONEER

Each different company We makes everything for MDx

makes products for MDx by our own technologies

Expensive! High cost

effectiveness!

Innovation•Value•Discovery l BIONEER 4
Features of BIONEER’s MDx

▌ Status of Global Business - Network

Diagnostic Distributor : about 30 counties

Branch : USA, China

Innovation•Value•Discovery l BIONEER 5
Features of BIONEER’s MDx

▌ Status of Global Business - Partners

BIONEER makes
global business
by cooperating
with many of
business partners!

Innovation•Value•Discovery l BIONEER 6
Features of BIONEER’s MDx

▌ Status of Global Business - Instrument

ExiPrep™ 16 Dx : 371 units

Exicycler™ 96 : 365 units

Innovation•Value•Discovery l BIONEER 7
 Features of BIONEER’s MDx

▌ History of BIONEER’s MDx Product

SARS
SARS Diagnostic
Solution :
Swine Flu (H1N1)
Ebola Virus
Diagnostic Kit : ZIKV Zika Multiplex
Diagnostic Kit : Diagnostic Kit
ABADIS development
about 2 million : 1st multiplex kit
Mobile PCR Lab with Nigeria
cases were tested on WHO EUAL
in China Government
2003 2009 2014 2016

~2008 2009 2010 2011 2013 2014 2015 2016 2018 2019~

▪ AccuPower® STI8A-Plex ▪ HIV-1 VL test kit was

▪ ExiStation™ Real-Time PCR Kit Listed in Global Fund
▪ ExiPrep™ 16 Dx ▪ AccuPower® CT&NG ▪ In the process of CE
▪ 14 types of AccuPower®
▪ 15 types of AccuPower® Real- Real-Time PCR Kit List A of HBV, HCV VL
Real-Time PCR Kit
Time PCR Kit test kits
(including MTB&NTM,
(including HPV 16&18 kit, STI
EBV, InfA and etc.) ▪ XDR- TB Kit &
multiplex kit and etc.)
IRON-qPCR(POCT) will
▪ AccuPower® BKV Quantitative be launched soon
PCR Kit

▪ Exicycler™ 96 ▪ AccuPower® MTB Real-Time ▪ 6 types of ExiPrep™ Dx Kit

▪ CE List A approval of
(2008) PCR Kit
▪ TB&MDR Real-Time PCR Kit ▪ Exicycler™ 96 V4 HIV-1 VL test Kit
ExiStation™ V4
▪ TV Real-Time PCR Kit ▪ 5 types of AccuPower®
Real-Time PCR Kit ▪ ExiStation™ 48
* This history is based on the year ▪ UU Real-Time PCR Kit
of achievement of CE mark. ▪ ExiStation™ 48A

▪ ExiPrep™ 48Dx

Innovation•Value•Discovery l BIONEER 8
 Features of BIONEER’s MDx

▌ Key Patents
Reagents and Kits (total 60)
No Application no. Patent no. Title Registered Pending
1 10-1999-004361 KR 0292883 Hot start PCR Mixture Comprising Pyrophosphate and Pyrophosphatase KR

2 10-2007-109055 KR 1098764 Dried Composition for hot-start PCR with Long-Term Stability KR, US, BR, IN, CN
KR(3), US, EP(GB, FR,
3 10-2011-0011639 KR 1818126 Reverse transcriptase having improved thermostability
DE), JP, CN
Compositions for hot start reverse transcription reaction or hot start reverse transcription EP(GB, DE, FR, CH),
4 10-2013-0025119 KR, US, CN, CA, IN, BR
polymerase chain reaction JP, AU, RU
5 10-2013-0091821 KR 1717953 New azo compound, use thereof, and process for preparing of the same JP EP, US, CN

Amplification system (total 91)

No Application no. Patent no. Title Registered Pending
1 10-2005-7018766 KR 0794703 Real-time monitoring apparatus for biochemical reaction KR, US, JP, CN EP
KR, US, JP, CN, EP
2 10-2007-064558 KR 1089045 Real-time PCR monitoring apparatus
(GB, DE, FR, IT)

Universal automatic apparatus for real time monitoring products of nucleic acid US, EP, CA, IN, BR, ,
3 10-2010-0021532 KR 1423936 KR, RU, JP, AU, ID
amplification reaction and method thereof TH, TR, CL

4 10-2010-0105630 KR 1420094 Automatic Real-time PCR system for the various analysis of biological sample KR, US, JP, CN, RU EP, IN

Purification system (total 45)

No Application no. Patent no. Title Registered Pending
Automatic purification apparatus with magnetic field applying part for biological samples
1 10-2011-0041126 KR 1443727 preparation and isolation method of target material from biological samples, and protein KR, US, RU, ID EP, IN, BR, TH, TR
expression and purification method
2 10-2012-0138335 KR 155534 Automatic cell-free protein production instrument KR
Automatic cell-free protein production instrument and protein production method using
3 13858370.3 JP, RU, AU EP, US, CN, IN
the same
Magnetic particle separation device and method for separating and purifying nucleic acid
4 10-2014-0174256 KR, US, EP, CN, JP
or protein

Innovation•Value•Discovery l BIONEER 9
Features of BIONEER’s MDx

▌ MDx System - ExiStation™ Series

ExiStation™ ExiStation™ 48* ExiStation™ 48A*

Through-put
Max. No. of test / a day Hands on time Hands on time
Configuration Extraction PCR Analysis
(9-hour workday) (for Extraction) (for PCR)

ExiStation™
48 tests 15min 1hr 30min 15min 1hr 20min
(with 1 Exiprep™ 16 Dx)

ExiStation™
96 tests 30min 1hr 30min 15min 1hr 20min
(with 2 Exiprep™ 16 Dx)

ExiStation™
144 tests 45min 1hr 30min 15min 1hr 20min
(with 3 Exiprep™ 16 Dx)

ExiStation™ 48 144 tests 35min 1hr 15min 1hr 20min

ExiStation™ 48A 192 tests 5min 1hr 20min* 15min 1hr 20min

*Including automatic sample preparation by ExiLT

Innovation•Value•Discovery l BIONEER 10
Features of BIONEER’s MDx

▌ MDx System - ExiStation™ 48A

Ultimate Molecular Diagnostic System with Full Automation

▪ Pipetting free
: Use primary tube directly
: decapping/capping of sample tube and
sample transfer motions are all automated.

▪ Sample information is inputted automatically

using built-in barcoding system

▪ Flexibility in sample numbers: 8 to 48 samples / run

▪ First result is delivered within 3.5 hr

and next result is delivered every 1.5 hr.

Innovation•Value•Discovery l BIONEER 11
Features of BIONEER’s MDx

▌ MDx System - ExiStation™

Simultaneous diagnosis : Random-access
▌ Simultaneous diagnosis
ExiPrep™ 16 Dx allows earlier detection of
superinfection, such as HIV
and TB.
→ Thus, saving more people.
Enter Information
using Barcode Scanner
Whole Blood Sputum Urine, Swabs ▌ Flexible sample numbers:
Serum, plasma
• MDR-TB,TB/NTM • STIs 1 to 16 samples/run
• HIV • HPV
• Pneumonia
• Hepatitis • RV
• ZIKV, DENV,CHIKV
▌ Flexible system configuration
Sample Prep
according to sample number

▌ Continuous workflow from

sample to result, within the
Analyze, Save results
shortest time of 3.5 hours for
& Report 48 tests.

Exicycler™ 96

Innovation•Value•Discovery l BIONEER 12
Features of BIONEER’s MDx

▌ Pipeline of MDx System - POC-qPCR

Features
• “Sample-in, Data-out” system
: Automatic process from sample preparation to Real-Time PCR
: No pre-treatment before sample preparation

• Outstanding Speed
: All process complete within 30min
Sample injection
: Hands-on time is < 1min to cartridge

: 2 sample can be run at the same time

• Various applications
: AMR (Anti-Microbial Resistance)
: TB-MDR & XDR (Extended Drug Resistance)
: HIV-1 / HBV / HCV viral load PCR reaction
20 min
: STI (Sexually Transmitted infections)
: Zika etc.

IRON-qPCR™ Workflow
Innovation•Value•Discovery l BIONEER 13
Various diagnostic kits

▌ List of BIONEER’s MDx Kits

Hepatitis • HBV Kit* Human • HPV 16&18 Kit

& HIV • HCV Kit* Papillomavirus
• HIV-1 Kit

Tuberculosis • XDR-TB Kit* Transplantation • CMV Kit*

• TB & MDR Kit -related • EBV Kit
• MTB & NTM Kit Disease • BKV Kit
• MTB Kit

Sexually • STI 8A Kit Gastro • Norovirus Kit

Transmitted (CT, NG, UU, MG) -intestinal • Enterovirus Kit
• STI 8B Kit Disease
Disease
(TV, MH, HSV1, HSV2)
• STI 4C Kit
(CA, GV, TP, UP)
Mosquito-borne • ZIKV multiplex Kit
Disease (ZIKV, DENV, CHIKV)
Respiratory • InfA Kit
Disease • New InfA Kit
• CP Kit*
• MP Kit Genotyping • HLA-B27 Kit*
• MERS-CoV Kit • MTHFR Kit
• Factor V Leiden Kit

* In the process of CE registration/approval

Innovation•Value•Discovery l BIONEER 14
Features of BIONEER’s MDx

▌ MDx Kit - HIV-1 AccuPower® HIV-1 Quantitative RT-PCR Kit 0197

Features
• CE List A approved HIV-1 VL test kit
• Quantification of HIV-1 viral load
• Specimens : EDTA-plasma
• Target & Analytical sensitivity
› Sensitive detection of various subtype of HIV-1 (group M, N and O)
› The LoD is 33.1 IU/ml (Subtype B)
› The LoQ is 50 IU/ml

The Result of Clinical Comparison with cobas® 6800 at Cerba Center in Paris

Roche cobas® 6800

(n=224)
Positive Negative
(n=111) (n=113)
Positive
111 0
ExiStation™ system (n=111)
(n=224) Negative
0 113
(n=113)

Innovation•Value•Discovery l BIONEER 15
Features of BIONEER’s MDx

▌ MDx Kit - Hepatitis B(HBV) AccuPower® HBV Quantitative PCR Kit

Features
• Quantification of HBV viral load
• Specimens : Serum, EDTA-plasma
• Target & Analytical sensitivity
› Sensitive detection of various genotype of HBV (genotype A to G)
› The LoD is 6.02 IU/ml (Genotype A2)
› The LoQ is 15 IU/ml

The Result of Clinical Comparison with cobas® 6800 at Cerba Center in Paris

Roche 6800 assay

(n=224)
Positive Negative
(n=113) (n=111)
Positive
113 0
ExiStation™ system (n=113)
(n=224) Negative
0 111
(n=111)

Innovation•Value•Discovery l BIONEER 16
Features of BIONEER’s MDx

▌ MDx Kit - Hepatitis C (HCV) AccuPower® HCV Quantitative RT-PCR Kit

Features
• Quantification of HCV viral load
• Specimens :Serum, EDTA-plasma
• Target & Analytical sensitivity
› Sensitive detection of various genotype of HCV (genotype 1 to 6)
› The LoD is 10.7 IU/ml (genotype 1a)
› The LoQ is 15 IU/ml

The Result of Clinical Comparison with cobas® 6800 at Cerba Center in Paris

Roche cobas® 6800

(n=230)
Positive Negative
(n=116) (n=114)
Positive
115 1
ExiStation™ system (n=116)
(n=230) Negative
1 113
(n=114)

Innovation•Value•Discovery l BIONEER 17
Various diagnostic kits

▌ MDx Kit – Mycobacterium Tuberculosis

Various types of TB related kits enable accurate diagnosis
• AccuPower® MTB&NTM Real-Time PCR Kit
• AccuPower® TB&MDR Real-Time PCR Kit
• AccuPower® XDR-TB Real-Time PCR Kit

AccuPower® MTB&NTM kit NTM detected

MTB detected

1st Drug
RIF Rifampicin
AccuPower® TB&MDR kit
TB&INH Isoniazid

EmbB Ethambutol
XDRB
rpsL Streptomycin 2nd Drug
AccuPower® XDR-TB kit
gyrA Fluoroquinolones
XDRA
rrs Second line injectable agents
(Amikacin, Capreomycin, Kanamycin)

Innovation•Value•Discovery l BIONEER 18
Various diagnostic kits

▌ MDx Kit - Mycobacterium Tuberculosis

Features of MDR-TB diagnostic Kit

• Simultaneous diagnosis of TB and MDR-TB
Target gene & mutant sites
• Specimens : Sputum, BAL, CSF, tissue, culture specimen
› Simple pretreatment of sputum samples by using EZ-Solution RIF TB&INH
(29 mutations) (7 mutations)

• Target
› MTB : IS6110 rpoB:
505Leu 526Asn
MTB:
IS6110
509Arg 526Leu
› RIF : rpoB (10 mutant sites, 29 mutations) 509Ile 526Gln katG:
511Pro 526Pro 315Ile
› INH : inhA, katG (3 mutant sites, 7 mutations) 513Lys 526Arg 315Asn
513Pro 526Gly 315Thr
513Leu 530Leu (ACC)
• Analytical Sensitivity 516Tyr 531Leu 315Thr
516Asn 531Ala (ACA)
› MTB : 21.88 copies/test 516Pro
516Gly
531Gln
531Trp inhA:
516Val
› RIF : 3.98 copies/test 518Ser
533Pro
533Thr
-15T
-8A
526Tyr 533Leu -8C
› INH : 179.8 copies/test 526Asp

Innovation•Value•Discovery l BIONEER 19
Various diagnostic kits

▌ MDx Kit - Mycobacterium Tuberculosis

Features of XDR-TB diagnostic Kit

• Simultaneous diagnosis of TB and XDR-TB Target gene & mutant sites

• Specimens : Sputum, BAL, CSF, tissue, culture specimen

› Simple pretreatment of sputum samples by using EZ-Solution XDRA XDRB

• Target
rpsL
› Fluoroquionolone : gyrA XDRA1 XDRA2
A128G

› Second line drug : rrs

A263G
gyrA gyrA
A90V D94G EmbB
› Streptomycin : rpsL S91P D94A M306V
D94N M306I
› Ethambutol : EmbB rrs rrs MTB
G1484T G1484T
IS6110
A1401G
C1402T

Innovation•Value•Discovery l BIONEER 20
Various diagnostic kits

▌ MDx Kit – Mosquito borne diseases

Features of ZIKV multiplex diagnostic Kit

• World 1st WHO EUA listed ZIKV multiplex diagnostic kit
• Simultaneous diagnosis of ZIKV, DENV and CHIKV
• Specimens : Plasma, Serum and urine

The Result of multi-site Clinical evaluation

Innovation•Value•Discovery l BIONEER 21
 Various diagnostic kits

▌ MDx Kit – Sexually Transmitted Infection

Features of STI diagnostic Kits

• Simultaneous diagnosis of 12 STI
using 3 types of multiplex kit and ExiStation system
› STI 8A Kit : CT, NG, UU, MG
› STI 8B Kit : TV, MH, HSV1, HSV2
› STI 4C Kit : UP, CA, TP, GV

• Specimens : Urine and vaginal swab

Clinical Performance of 3 types of STI multiplex kit

AccuPower® STI 8A-plex Real-Time PCR Kit AccuPower® STI 8B-plex Real-Time PCR Kit AccuPower® STI 4C-plex Real-Time PCR Kit
Target Sensitivity Specificity Target Sensitivity Specificity Target Sensitivity Specificity

CT 100% (95%C.I 94.8-100) 100% (95%C.I 75.3-100) TV 100% (95%C.I 90.5-100) 100% (95%C.I 76.8-100) UP 100% (95%C.I 98.1-100) 99.5% (95%C.I 97.2-99.9)

NG 100% (95%C.I 93.6-100) 100% (95%C.I 76.8-100) MH 100% (95%C.I 92.7-100) 100% (95%C.I 75.29-100) CA 100% (95%C.I 96.9-100) 99.3% (95%C.I 97.4-99.9)

UU 100% (95%C.I 92.7-100) 100% (95%C.I 76.8-100) HSV1 100% (95%C.I 88.4-100) 100% (95%C.I 75.3-100) TP 100% (95%C.I 74.1-100) 99.7% (95%C.I 98.4-100)

MG 100% (95%C.I 93.5-100) 100% (95%C.I 976.8-100) HSV2 100% (95%C.I 92.5-100) 87.5% (95%C.I 61.65-98.5) GV 100% (95%C.I 98.3-100) 100% (95%C.I 97.8-100)

Innovation•Value•Discovery l BIONEER 22
Summary

▌ BIONEER provides affordable MDx for the world!

Full responsibility of QMS by the integration of in-house

developed systems and kits including raw materials.

Multi-valent system up to 16 multiplex assay

Outstanding sensitivity & reproducibility

Easy to operate; one-day training is enough

High cost effectiveness

Innovation•Value•Discovery l BIONEER 23
 Thank you
www.bioneer.com