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.
▌ Who is BIONEER?
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 2
Based on integrated molecular technology,
We delivers TOTAL SOLUTION for MDx
Established
19921st Bio-venture
in Korea
Invest 35%of the annual revenues
R&D
Various MDx products
using own technologies
▌ BIONEER’s MDx
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 3
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
▌ BIONEER’s MDx
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 4
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
▌ Status of Global Business - Network
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 5
Diagnostic Distributor : about 30 counties
Branch : USA, China
▌ Status of Global Business - Partners
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 6
BIONEER makes
global business
by cooperating
with many of
business partners!
▌ 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
▪ ExiStation™ V4
▪ ExiStation™ 48
▪ ExiStation™ 48A
▪ ExiPrep™ 48Dx
▪ ExiPrep™ 48 Viral
DNA/RNA Kit
▪ ExiPrep™ 48 Viral
RNA Kit
~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.
2018~(Plan)
▪ CE List A of
HBV, HCV, HIV-1
diagnostic kit
▪ XDR- TB Launching
Innovation•Vale•Discovery l BIONEER 7
▌ 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•Vale•Discovery l BIONEER 8
▌ MDx System - ExiStation™ Series
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 9
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*
▌ 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•Vale•Discovery l BIONEER 10
▌ MDx System - ExiStation™
Features of BIONEER’s MDx
▌ Flexible sample numbers:
1 to 16 samples/run
▌ Flexible system configuration
according to sample number
▌ Simultaneous diagnosis allows
earlier detection of superinfection,
such as HIV and TB.
→ Thus, saving more people.
▌ Easy and efficient control of sample
information by scanning barcode
only once.
▌ 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•Vale•Discovery l BIONEER 11
▌ Pipeline of MDx System - POC-qPCR
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 12
Features
• 2 types of instrument; for 2-cartridge & 4-cartridge
• All process complete within 30min
› Automatic process from sample preparation to Real-Time PCR
› No pre-treatment before sample preparation
Instrument for 2-cartridge Instrument for 4-cartridge
* Specifications & features of product can be changed.
Sample injection
to cartridge
PCR reaction
20 min
Workflow
Applications
• Potential to Polyvalent assays
› RV16 (Respiratory viruses)
› AMR (Antimicrobial resistance)
› TB-MDR (Tuberculosis-Multi drug resistance)
& XDR(Extended Drug Resistance)
› HIV-1 / HBV / HCV viral load
› STI (Sexually Transmitted infections)
▌ Pipeline of MDx System - POC-qPCR
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 13
* Specifications & features of product can be changed.
PCR plates
Cartridge (assembled)
4-Channel2-Channel 8-Channel
PCR plateNucleic acid
Prep part
Sample Inlet
Reaction
well
▌ List of BIONEER’s MDx Kits
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 14
Sexually
Transmitted
Disease
• STI 8A Kit
(CT, NG, UU, MG)
• STI 8B Kit
(TV, MH, HSV1, HSV2)
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
• HPV Genotyping Kit
Tuberculosis • MTB Kit
• MTB & NTM Kit
• TB & MDR Kit
• MTHFR Kit
• JAK2 V617F Kit
Genotyping • ApoE Kit
• Warfarin Kit
• HLA-B27 Kit
• TPMT Kit
• Factor V Leiden Kit
Features
• 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
Innovation•Vale•Discovery l BIONEER 15
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
Innovation•Vale•Discovery l BIONEER 16
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
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
Innovation•Vale•Discovery l BIONEER 17
▌ MDx Kit - Tuberculosis
Features of BIONEER’s MDx
TB/NTM 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 (In the development)
Innovation•Vale•Discovery l BIONEER 18
▌ MDx Kit - Tuberculosis
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 19
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
▌ MDx Kit - Tuberculosis
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 20
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
› gyrA : Codon 90~94 (Fluoroquionolone)
› rpsL : Codon 43, 88 (Aminoglycosides (Amikacin, Capreomycin,
Kanamycin)
› rrs : Nucleotide 513~517, 1401, 1402, 1484 (Streptomycin)
› embB : Codon 306 (Ethambutol)
XDRA XDRB
XDRA1 XDRA2
EmbB
M306V
M306I
rpsL
A128G
A263G
gyrA
A90V
S91P
rrs
G1484T
gyrA
D94G
D94A
D94N
rrs
A1401G
C1402T
MTB
IS6110
Target gene & mutant sites
▌ MDx Kit - Human Papilloma Virus(HPV)
Features of BIONEER’s MDx
Innovation•Vale•Discovery l BIONEER 21
Features
• Simultaneous diagnosis of HPV 16 & HPV 18
• Specimens : Cervical swab
• Analytical Sensitivity
› HPV 16 : 13.18 copies/test
› HPV 18 : 10.18 copies/test
Correlation with Reference Method
• Comparison study with reference method
• Using total 22 clinical samplesSeeGene Seeplex®
Positive Negative Total
AccuPower®
HPV 16&18
Real-Time PCR
Kit
Positive 12 - 12
Negative - 10 10
Total 12 10 22
* Those results agreed 100% with those from direct sequencing results
▌ BIONEER provides affordable MDx for the world!
Summary
Innovation•Vale•Discovery l BIONEER 22
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.