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.
Innovation•Value•Discovery l BIONEER 2
▌ Who is BIONEER?
Features of BIONEER’s MDx
Based on integrated molecular technology,
We delivers TOTAL SOLUTION for MDx
Established
19921st Bio-venture
in Korea
Cooperation
with our partners
in approx. countries
Various MDx products
using own technologies30
1
Innovation•Value•Discovery l BIONEER 3
▌ BIONEER’s MDx
Features of BIONEER’s MDx
We guarantee of FULL RESPONSIBILITY for MDx
MDx
System
Various
Diagnostic
Kits
In-house
Raw
Material
Production
BIONEER provides total solution of MDx
by integrated technologies
Innovation•Value•Discovery l BIONEER 4
▌ BIONEER’s MDx
Features of BIONEER’s MDx
Raw
material
MDx
system
MDx
kits
Company A Company B Company C
Raw material
MDx system
MDx Kits
BIONEER
Expensive! High cost effectiveness!
Each different company
makes products for MDx
We makes everything for MDx
by our own technologies
Innovation•Value•Discovery l BIONEER 5
▌ Status of Global Business - Network
Features of BIONEER’s MDx
Diagnostic Distributor : about 30 counties
Branch : USA, China
Innovation•Value•Discovery l BIONEER 6
▌ Status of Global Business - Partners
Features of BIONEER’s MDx
BIONEER makes
global business
by cooperating
with many of
business partners!
Innovation•Value•Discovery l BIONEER 7
▌ Status of Global Business - Instrument
Features of BIONEER’s MDx
ExiPrep™ 16 Dx : 371 units
Exicycler™ 96 : 365 units
Innovation•Value•Discovery l BIONEER 8
▌ History of BIONEER’s MDx Product
Features of BIONEER’s MDx
▪ 6 types of ExiPrep™ Dx Kit
▪ TB&MDR Real-Time PCR Kit
▪ TV Real-Time PCR Kit
▪ UU Real-Time PCR Kit
▪ Exicycler™ 96 V4
▪ 5 types of AccuPower®
Real-Time PCR Kit
▪ AccuPower® STI8A-Plex
Real-Time PCR Kit
▪ AccuPower® CT&NG
Real-Time PCR Kit
▪ ExiStation™
▪ ExiPrep™ 16 Dx
▪ 15 types of AccuPower® Real-
Time PCR Kit
(including HPV 16&18 kit, STI
multiplex kit and etc.)
▪ Exicycler™ 96
(2008)
▪ 14 types of AccuPower®
Real-Time PCR Kit
(including MTB&NTM,
EBV, InfA and etc.)
▪ AccuPower® BKV Quantitative
PCR Kit
▪ AccuPower® MTB Real-Time
PCR Kit ▪ CE List A approval of
HIV-1 VL test Kit
ExiStation™ V4
▪ ExiStation™ 48
▪ ExiStation™ 48A
▪ ExiPrep™ 48Dx
~2008 2013 2015 20162011 20142009 2010 2018
2003
SARS Diagnostic Solution : ABADIS
Mobile PCR Lab in China
2009
Swine Flu (H1N1)
Diagnostic Kit :
about 2 million
cases were tested2014
Ebola Virus
Diagnostic Kit :
development
with Nigeria
Government 2016
Zika Multiplex
Diagnostic Kit
: 1st multiplex kit
on WHO EUAL
* This history is based on the year
of achievement of CE mark.
2019~
▪ HIV-1 VL test kit was
Listed in Global Fund
▪ In the process of CE
List A of HBV, HCV VL
test kits
▪ XDR- TB Kit &
IRON-qPCR(POCT) will
be launched soon
ZIKVSARS
Innovation•Value•Discovery l BIONEER 9
▌ Key Patents
Features of BIONEER’s MDx
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
3 10-2011-0011639 KR 1818126 Reverse transcriptase having improved thermostabilityKR(3), US, EP(GB, FR,
DE), JP, CN
4 10-2013-0025119Compositions for hot start reverse transcription reaction or hot start reverse transcription
polymerase chain reaction
EP(GB, DE, FR, CH),
JP, AU, RUKR, US, CN, CA, IN, BR
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
2 10-2007-064558 KR 1089045 Real-time PCR monitoring apparatusKR, US, JP, CN, EP
(GB, DE, FR, IT)
3 10-2010-0021532 KR 1423936Universal automatic apparatus for real time monitoring products of nucleic acid
amplification reaction and method thereofKR, RU, JP, AU, ID
US, EP, CA, IN, BR, ,
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
1 10-2011-0041126 KR 1443727
Automatic purification apparatus with magnetic field applying part for biological samples
preparation and isolation method of target material from biological samples, and protein
expression and purification method
KR, US, RU, ID EP, IN, BR, TH, TR
2 10-2012-0138335 KR 155534 Automatic cell-free protein production instrument KR
3 13858370.3Automatic cell-free protein production instrument and protein production method using
the sameJP, RU, AU EP, US, CN, IN
4 10-2014-0174256Magnetic particle separation device and method for separating and purifying nucleic acid
or proteinKR, US, EP, CN, JP
Innovation•Value•Discovery l BIONEER 10
▌ MDx System - ExiStation™ Series
Features of BIONEER’s MDx
ConfigurationMax. No. of test / a day
(9-hour workday)
Hands on time
(for Extraction)Extraction
Hands on time
(for PCR)PCR Analysis
ExiStation™
(with 1 Exiprep™ 16 Dx)48 tests 15min 1hr 30min 15min 1hr 20min
ExiStation™
(with 2 Exiprep™ 16 Dx)96 tests 30min 1hr 30min 15min 1hr 20min
ExiStation™
(with 3 Exiprep™ 16 Dx)144 tests 45min 1hr 30min 15min 1hr 20min
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
Through-put
ExiStation™ ExiStation™ 48A*ExiStation™ 48*
Innovation•Value•Discovery l BIONEER 11
▌ MDx System - ExiStation™ 48A
Features of BIONEER’s MDx
▪ 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.
Ultimate Molecular Diagnostic System with Full Automation
Innovation•Value•Discovery l BIONEER 12
▌ MDx System - ExiStation™
Features of BIONEER’s MDx
▌ Simultaneous diagnosis
allows earlier detection of
superinfection, such as HIV
and TB.
→ Thus, saving more people.
▌ Flexible sample numbers:
1 to 16 samples/run
▌ Flexible system configuration
according to sample number
▌ Continuous workflow from
sample to result, within the
shortest time of 3.5 hours for
48 tests.
ExiPrep™ 16 Dx
Exicycler™ 96
Sample Prep
Analyze, Save results
& Report
Sputum
Enter Information
using Barcode Scanner
Simultaneous diagnosis : Random-access
• HIV
• Hepatitis
• ZIKV, DENV,CHIKV
Whole Blood
Serum, plasma• STIs
• HPV
• RV
• MDR-TB,TB/NTM
• Pneumonia
Urine, Swabs
Innovation•Value•Discovery l BIONEER 13
▌ Pipeline of MDx System - POC-qPCR
Features of BIONEER’s MDx
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
: Hands-on time is < 1min
: 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
: STI (Sexually Transmitted infections)
: Zika etc.
Sample injection
to cartridge
PCR reaction
20 min
IRON-qPCR™ Workflow
Innovation•Value•Discovery l BIONEER 14
▌ List of BIONEER’s MDx Kits
Various diagnostic kits
Sexually
Transmitted
Disease
• STI 8A Kit
(CT, NG, UU, MG)
• STI 8B Kit
(TV, MH, HSV1, HSV2)
• STI 4C Kit
(CA, GV, TP, UP)
Hepatitis
& HIV
• HBV Kit*
• HCV Kit*
• HIV-1 Kit
Transplantation
-related
Disease
• CMV Kit*
• EBV Kit
• BKV Kit
Gastro
-intestinal
Disease
• Norovirus Kit
• Enterovirus Kit
Mosquito-borne
Disease• ZIKV multiplex Kit
(ZIKV, DENV, CHIKV)
Respiratory
Disease
• InfA Kit
• New InfA Kit
• CP Kit*
• MP Kit
• MERS-CoV Kit
Human
Papillomavirus
• HPV 16&18 Kit
Tuberculosis • XDR-TB Kit*
• TB & MDR Kit
• MTB & NTM Kit
• MTB Kit
* In the process of CE registration/approval
Genotyping • HLA-B27 Kit*
• MTHFR Kit
• Factor V Leiden Kit
Innovation•Value•Discovery l BIONEER 15
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
▌ MDx Kit - HIV-1
Features of BIONEER’s MDx
The Result of Clinical Comparison with cobas® 6800 at Cerba Center in Paris
Roche cobas® 6800
(n=224)
Positive
(n=111)
Negative
(n=113)
ExiStation™ system
(n=224)
Positive
(n=111)111 0
Negative
(n=113)0 113
AccuPower® HIV-1 Quantitative RT-PCR Kit 0197
Innovation•Value•Discovery l BIONEER 16
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
▌ MDx Kit - Hepatitis B(HBV)
Features of BIONEER’s MDx
The Result of Clinical Comparison with cobas® 6800 at Cerba Center in Paris
Roche 6800 assay
(n=224)
Positive
(n=113)
Negative
(n=111)
ExiStation™ system
(n=224)
Positive
(n=113)113 0
Negative
(n=111)0 111
AccuPower® HBV Quantitative PCR Kit
Innovation•Value•Discovery l BIONEER 17
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
▌ MDx Kit - Hepatitis C (HCV)
Features of BIONEER’s MDx
The Result of Clinical Comparison with cobas® 6800 at Cerba Center in Paris
Roche cobas® 6800
(n=230)
Positive
(n=116)
Negative
(n=114)
ExiStation™ system
(n=230)
Positive
(n=116)115 1
Negative
(n=114)1 113
AccuPower® HCV Quantitative RT-PCR Kit
Innovation•Value•Discovery l BIONEER 18
▌ MDx Kit – Mycobacterium Tuberculosis
Various diagnostic kits
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
RIFAccuPower® TB&MDR kit
TB&INH
XDRB
AccuPower® XDR-TB kit
XDRA
EmbB
gyrA
rpsL
rrs
Rifampicin
Isoniazid
Ethambutol
Fluoroquinolones
Second line injectable agents
(Amikacin, Capreomycin, Kanamycin)
Streptomycin
AccuPower® MTB&NTM kit
MTB detected
NTM detected
1st Drug
2nd Drug
Innovation•Value•Discovery l BIONEER 19
▌ MDx Kit - Mycobacterium Tuberculosis
Various diagnostic kits
Features of MDR-TB diagnostic Kit
• Simultaneous diagnosis of TB and MDR-TB
• Specimens : Sputum, BAL, CSF, tissue, culture specimen
› Simple pretreatment of sputum samples by using EZ-Solution
• Target
› MTB : IS6110
› RIF : rpoB (10 mutant sites, 29 mutations)
› INH : inhA, katG (3 mutant sites, 7 mutations)
• Analytical Sensitivity
› MTB : 21.88 copies/test
› RIF : 3.98 copies/test
› INH : 179.8 copies/test
Target gene & mutant sites
rpoB:505Leu509Arg509Ile511Pro513Lys513Pro513Leu516Tyr516Asn516Pro516Gly516Val518Ser526Tyr526Asp
MTB:IS6110
katG:315Ile315Asn315Thr(ACC)315Thr(ACA)
inhA:-15T-8A-8C
RIF(29 mutations)
TB&INH(7 mutations)
526Asn526Leu526Gln526Pro526Arg526Gly530Leu531Leu531Ala531Gln531Trp533Pro533Thr533Leu
Innovation•Value•Discovery l BIONEER 20
▌ MDx Kit - Mycobacterium Tuberculosis
Various diagnostic kits
Features of XDR-TB diagnostic Kit
• Simultaneous diagnosis of TB and XDR-TB
• Specimens : Sputum, BAL, CSF, tissue, culture specimen
› Simple pretreatment of sputum samples by using EZ-Solution
• Target
› Fluoroquionolone : gyrA
› Second line drug : rrs
› Streptomycin : rpsL
› Ethambutol : EmbB
XDRB
Target gene & mutant sites
rpsL
A128G
A263G
EmbB
M306V
M306I
MTB
IS6110
gyrA
A90V
S91P
gyrA
D94G
D94A
D94N
rrsG1484T
A1401G
C1402T
XDRA1 XDRA2
rrs
G1484T
XDRA
Innovation•Value•Discovery l BIONEER 21
▌ MDx Kit – Mosquito borne diseases
Various diagnostic kits
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 22
▌ MDx Kit – Sexually Transmitted Infection
Various diagnostic kits
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
AccuPower® STI 8A-plex Real-Time PCR Kit
Target Sensitivity Specificity
CT 100% (95%C.I 94.8-100) 100% (95%C.I 75.3-100)
NG 100% (95%C.I 93.6-100) 100% (95%C.I 76.8-100)
UU 100% (95%C.I 92.7-100) 100% (95%C.I 76.8-100)
MG 100% (95%C.I 93.5-100) 100% (95%C.I 976.8-100)
AccuPower® STI 8B-plex Real-Time PCR Kit
Target Sensitivity Specificity
TV 100% (95%C.I 90.5-100) 100% (95%C.I 76.8-100)
MH 100% (95%C.I 92.7-100) 100% (95%C.I 75.29-100)
HSV1 100% (95%C.I 88.4-100) 100% (95%C.I 75.3-100)
HSV2 100% (95%C.I 92.5-100) 87.5% (95%C.I 61.65-98.5)
AccuPower® STI 4C-plex Real-Time PCR Kit
Target Sensitivity Specificity
UP 100% (95%C.I 98.1-100) 99.5% (95%C.I 97.2-99.9)
CA 100% (95%C.I 96.9-100) 99.3% (95%C.I 97.4-99.9)
TP 100% (95%C.I 74.1-100) 99.7% (95%C.I 98.4-100)
GV 100% (95%C.I 98.3-100) 100% (95%C.I 97.8-100)
Clinical Performance of 3 types of STI multiplex kit
Innovation•Value•Discovery l BIONEER 23
▌ BIONEER provides affordable MDx for the world!
Summary
Outstanding sensitivity & reproducibility
Multi-valent system up to 16 multiplex assay
Easy to operate; one-day training is enough
High cost effectiveness
Full responsibility of QMS by the integration of in-house
developed systems and kits including raw materials.
Thank youwww.bioneer.com