Making a Healthier Future for Humanity...History of BIONEER’s MDx ProductFeatures of BIONEER’s MDx 6 types of ExiPrep Dx Kit TB&MDR Real-Time PCR Kit TV Real-Time PCR Kit UU Real-Time

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



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



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



Diagnostic Distributor : about 30 counties

Branch : USA, China

▌ Status of Global Business - Partners



BIONEER makes

global business

by cooperating

with many of

business partners!

▌ History of BIONEER’s MDx Product


▪ 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


▌ 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

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


▌ MDx System - ExiStation™ Series



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™


ExiStation™


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


▪ 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


▌ MDx System - ExiStation™


▌ 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


https://www.google.co.kr/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwihgNm8gMrLAhUF26YKHVIyCxsQjRwIBw&url=https://commons.wikimedia.org/wiki/File:Plessey_barcode.svg&bvm=bv.117218890,d.dGo&psig=AFQjCNFZoyIYSpY2pevXJTO42pWOnNkMYQ&ust=1458382533031577

▌ Pipeline of MDx System - POC-qPCR



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



* 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



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


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


Features

• Quantification of HBV viral load

• Specimens : Serum, EDTA-plasma


› Sensitive detection of various genotype of HBV (genotype A to G)

› The LoD is 6.02 IU/ml (Genotype A2)


▌ MDx Kit - Hepatitis B(HBV)




Roche 6800 assay

(n=224)

Positive

(n=113)

Negative

(n=111)


(n=224)

Positive

(n=113)113 0

Negative

(n=111)0 111

Features

• Quantification of HCV viral load

• Specimens :Serum, EDTA-plasma


› Sensitive detection of various genotype of HCV (genotype 1 to 6)

› The LoD is 10.7 IU/ml (genotype 1a)


▌ MDx Kit - Hepatitis C (HCV)



Roche cobas® 6800

(n=230)

Positive

(n=116)

Negative

(n=114)


(n=230)

Positive

(n=116)115 1

Negative

(n=114)1 113


▌ MDx Kit - Tuberculosis


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)





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




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

• 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


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

Documents

Making a Healthier Future for Humanity...History of BIONEER’s MDx ProductFeatures of BIONEER’s MDx 6 types of ExiPrep Dx Kit TB&MDR Real-Time PCR Kit TV Real-Time PCR Kit UU Real-Time