making a healthier future for humanity...innovation•value•discovery l bioneer 8 history of...

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


▌ 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!


▌ Status of Global Business - Instrument


ExiPrep™ 16 Dx : 371 units

Exicycler™ 96 : 365 units


▌ 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 ▪ 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


▌ 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™


▌ 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

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

• “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


▌ 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


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


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


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

AccuPower® HBV Quantitative PCR Kit


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

AccuPower® HCV Quantitative RT-PCR Kit


▌ 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

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


▌ MDx Kit - Mycobacterium Tuberculosis


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 - Mycobacterium Tuberculosis


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


▌ 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


▌ 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

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


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


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


▌ 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

making a healthier future for humanity...innovation•value•discovery l bioneer 8 history of...

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