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[FOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTION]

SD BIOSENSORTotal Solutions for COVID-19 Diagnosis

2020.03.08

ContentsTable of contents


• Company Introduction & History

• Overview of Products

• Coronavirus Diagnostic Kits

Chronic CareBGMSLipidoCareMultiCare

STANDARD QRapid diagnostics test

STANDARD F Fluorescentimmunoassay

STANDARD E ELISA

STANDARD MMolecular POC system

STANDARD QCOVID-19 Ag TestCOVID-19 IgM/IgG Duo TestSTANDARD F COVID-19 Ag FIASTANDARD MnCoV Real-Time Detection kit


Company Introduction & History

[FOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTION] 4

SD BIOSENSOR in KOREA

• Company name : SD BIOSENSOR, INC.

• Foundation date : Dec. 2010.

• No. of employees : 418

• Branches : India, Indonesia, China

• 2019 Sales : 73.6 million USD(Oversea sales : $ 57.3M, domestic sales : $ 16.7M)

• More than 130 distribution partners in more than 100 countries.

Headquarter(Suwon in South Korea)

Factory(Osong in South Korea)


Company Introduction

Screening Test Confirmatory Test

Chronic CareBGMS/LipidoCare/

MultiCare

STANDARD QRapid diagnostics test

STANDARD F Fluorescent

immunoassay

STANDARD E ELISA

STANDARD MMolecular POC system

SD BIOSENSOR has been developing and manufacturing innovative diagnostic platforms that focus on;

• Point of Care Testing

• From screening tests to simple and reliable confirmatory tests


Company History | Development of products

1999. 02

2010. 12

2013. 09

2013. 09

2015. 05

2016. 09

Standard Diagnostics, Inc.(SD) establishment by Dr. Cho

Spun off SD BIOSENSOR from SD (SD merged by Alere – now Abbott)

Completed construction of Cheongwon manufacturing facility

Changed India branch name (SD BIOSENSOR Healthcare)

SD BIOSENSOR China in Shanghai establishment

Zika IgG/IgM diagnosis kit

2009.08 World first Influenza A(H1N1pdm09) diagnosis kit

2003.07 World first SARS Antibody, Antigen diagnosis kit

2003.02 Listed to Korean stock market

2015. 04 MERS-CoV Antigen diagnosis kit

2014. 12 Ebola Zaire Antigen diagnosis kit

2015. 09 Manufacturing facility in India establishment

2016. 05 STANDARD F(Fluorescent Immunoassay) Launched

2018. 05 High-throughput diagnostics system ‘STANDARD F2400’ launched

2019. 01 Latent Tuberculosis diagnosis kit

2019. 04 • WHO PQ Site Inspection report listed• Arbo Panel I (Zika, Dengue, Chikungunya, Yellow fever) diagnosis kit

2019. 08

2020. 02

HIV/Syphilis Combo diagnosis kit

• 2019-nCoV Real-time detection kit diagnosis kit• COVID-19 IgM/IgG Duo diagnosis kit

2020. 03 • HCV Ab diagnosis kit• Malaria P.f Ag, Malaria P.f/Pan Ag diagnosis kit• Malaria P.f/P.v Ag diagnosis kit• COVID-19 Ag diagnosis kit

- WHO PQ Approved

- The Global Fund ERPD Approved

- UNICEF long term supply agreement signed

- KFDA EUA Approved

- World 1st

- World 1st

- WHO EUAL

- WHO PQ Approved- WHO PQ Approved


SD BIOSENSOR| Core Technology

Core technology covers from reagent

to equipment

Formulation technology• Correct formulation can produce

accurate, ready-to-use diagnostic test.

• FIA / RDT / ELISA

Recombinant antigen• We have been developing a range

of recombinant human antigens with a focus on E.coli expression systems.

Monoclonal antibody• Diverse range of monoclonal

antibodies such as tumor markers, infectious diseases, diabetes, hormone, and etc

Medical instrument• Electric circuit and medical instrument

designs• Firmware and embedded software

development

Smart phone apps and server construction• One-stop development process is

available from H/W levels of the in vitro diagnostic system to IT services.

MDx POC • Loop-mediated amplification (LAMP) • Extraction and amplification within

30mins


Overview of Products


STANDARD™ Q Rapid Test | Available NOW

More than 40 immune chromatographic test kits are available.

• Malaria P.f Ag• Malaria P.f/P.v Ag

• Malaria P.f/Pan Ag• Dengue Duo

• Dengue NS1 Ag• Dengue IgM/IgG• Chikungunya IgM/IgG

• Zika IgM• Yellow fever IgM

• Dengue/Chikungunya Trio • Zika/Dengue Fast Trio• ZIKV/DENV/CHIKV Fast Quad

• Arbo Panel I (Z/D/C/Y)• Tsutsugamushi IgM/IgG

• Leptospira IgM/IgG• Malaria/CRP Duo

• Influenza A&B*• Strep A

• RSV Ag*• Legionella Ag*

• S. pneumoniae Ag*• MERS-CoV Ag• TB MPT64 Ag

• Adeno Respi Ag• COVID-19 Ag

• COVID-19 IgM/IgG Duo

Vector borne

• Rotavirus Ag*• Rota/Adeno Ag*

• Norovirus Ag• H. pylori Ab

• H. pylori Ag

Respiratory

• HIV/Syphilis Combo• HIV 1/2 Ab (3line)*

• HIV 1/2 Ab (4line)• Syphilis Ab

• HCV Ab*• HBsAg*• Anti-HBs*

• HAV IgM

Blood borne

Gastrointestinal

1st

1st

1st

1st

• Ebola Zaire Ag

Hemorrhagic fever

1st : world-first product• : KFDA approved

WHO PQ : WHO PQ Approved

WHO PQ

WHO PQ

WHO PQ

WHO PQ


STANDARD™ F Fluorescent Immunoassay | Available NOW

Metabolite• HbA1c*• U-Albumin*

Inflammation

• PCT (Serum)*• PCT*• CRP*

Tumor

• PSA • iFOB*

Respiratory

• Influenza A&B*• RSV Ag*• Legionella Ag*• S. pneumoniae Ag*• Strep A• Adenovirus Respi Ag• TB-Feron FIA(IFN-gamma)• COVID-19 Ag

Blood-borne

• HCV Ab • HIV Ag/Ab• HAV IgM• Syphilis Ab

Hormone

• β-hCG*• LH*• TSH*• T4*• fT4*

Cardiovascular

• TnI• CK-MB • hs-CRP • D-dimer*• NT-proBNP

Vector-borne

• Dengue NS1• Dengue IgM/IgG• Chikungunya IgM/IgG• Zika Ag• Zika IgM• Zika Total Ab• Tsutsugamushi IgM/IgG• Lyme IgM/IgG

Gastrointestinal

• Rotavirus Ag*• Rota/Adeno Ag*• C. difficile GDH

Qualitative

* : KFDA approved

STANDARD F Analyzers

• Test capacity : 70 tests/h• Auto discarding• Memory : 5,000 results• Connectivity : HL-7 v2.6• Printer : Built-in• Power : AC/DC Adapter• Size : 510 x 566 x 297(mm)• Weight : 20 kg

• Test capacity : 4 tests/h(STANDARD MODE)

• Memory : 3,000 results• Connectivity : HL-7 v2.6• Printer : Built-in• Power : AC/DC Adapter• Size : 200 x 240 x 205(mm)• Weight : 2.7 kg

• Test capacity : 4 tests/h(STANDARD MODE)

• Memory : 1,000 results• Connectivity : Bluetooth dongle• Printer : External• Power : Battery(AAx4), AC/DC

Adapter• Size : 105 x 135 x 100(mm)• Weight : 600 g

Quantitative

F2400 F200 F100

All the qualitative & quantitative assay are available for any F analyzer - F100, F200, F2400.


STANDARD™ M | Molecular POC system

“ Versatile POC MDx Platform”

Isothermal amplification + qPCR in one platform

Simple & FastSample in à Result out / 30mins (TAT)

Various MenusRespiratory, Hepatitis, HIV, TB, Arbovirus, etc.

Modular & ScalableScalable configuration for customized throughput

MultiplexMaximum 12 targets including Internal control

Modular system

1 Operator + Multiple Analyzer


2019 2020 2021~

Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Launching Schedule Analytical evaluation Clinical evaluation Registration: CE/KFDA/FDA/etc.

Target Specimen TAT Storage Condition

Qua

litat

ive

Ass

ay(Is

othe

rmal

am

p.)

Flu/RSV Influenza A – H1N1/H3N2/pdm09,

Influenza B, RSV A, RSV BUTM 30 mins 2-28℃

Arbovirus 6(ZIKV/DENV/CHIKV)

Zika virus, Chikungunya virus,

Dengue virus 1~4Serum 30 mins 2-28℃

ZIKV Zika virus Urine 30 mins 2-28℃

MDR-TB TB(IS6110, IS1081), RIF(rpoB),

INH(katG, inhA)Sputum 60 mins 2-28℃

Qua

ntita

tive

Ass

ay(q

PCR

)

HIV-1 VL HIV-1 viral load Serum, Plasma 90 mins 2-28℃

HBV VL HBV viral load Serum, Plasma 90 mins 2-28℃

HCV VL HCV viral load Serum, Plasma 90 mins 2-28℃

STANDARD™ M | Assay Development Plan (2019~)


Coronavirus Diagnostics Kits


COVID-19 | Parallel inspection methods recommended

Additional complementary test methods for the efficient quarantine

• Pros : The most sensitive testing method for diagnosing viruses (Before symptoms are expressed)• Cons : Long running time ( 6 hrs), Complicated procedures, Professional technician use only, Specialized machines needed for

read results

PCR

• Pros : Simple test procedure, Faster decision making for an isolation with fast test result• Cons : Less Sensitivity than PCR

STANDARD Antigen Rapid kit

• Pros : In case of negative results in PCR due to a drop in the titer of the antigen virus, antibody tests can be useful to check antibody formations and conduct a corresponding patient epidemiological investigation.

• Cons : Unable to diagnosis at early stage

STANDARD Q Covid-19 IgM/IgG Rapid kit

Reference : Cellular immune responses to severe acute respiratory syndrome coronavirus infection in senescent BALB/c Mice:CD4+ T cells are important in control of SARD-CoV infection. Jun Chen.Chronological evolution of IgM, IgA, IgG and neutralization antibodies after infection with SARD-Associated coronavirus. P.R Hsueh.

Mechanisms of Host defense following severe acute respiratory syndrome-coronavirus pulmonary infection of mice.SARS immunity and vaccination. Minsheng Zhu.

Days post infection

Mean Titer

Mag

nitu

de o

f res

pons

e

Virus titer Pneumoniasymptoms

IgMconcentration

IgGconcentration

Initial infection Symptom onset

1:1280

1:640

1:320

1:160

1:80

1:40

1:20

1:10

Antigenconcentration

CurrentMethod to diagnosis


• 2020. 03. 11 CE Self-Declaration (expected)

• 2020. 03. 27 Export license (expected)

• 2020. 03. 10 CE Self-Declaration




COVID-19 | Total platform

• 2020. 02.28 Export license

• 2020. 02.28 Korea FDA EUA approved


STANDARD M nCoV Real-Time Detection kit

STANDARD F COVID-19 Ag FIA • Purpose : COVID-19 antigen detection in nasopharyngeal or throat specimen

• Fluorescent Immunoassay (Europium)

• High sensitivity

• Result reader : F2400, F200, F100

• Test time : within 30 mins

• Purpose : COVID-19 RNA detection

• Nucleic acid amplification reaction

• Applicable machine : CFX96. ABI7500


STANDARD Q COVID-19 Ag

STANDARD Q COVID-19 IgM/IgG Duo • Purpose : COVID-19 antibodies detection in serum, plasma or whole blood

• Immune chromatographic test


• Purpose : COVID-19 antigen detection in nasopharyngeal or throat specimen

• Immune chromatographic test



STANDARD F COVID-19 Ag | Performance

Test site : Seoul National University Bundang Hospital

Objective : Test for effectiveness evaluation of STANDARD F COVID-19 Ag FIA

Specimen Information : Nasopharyngeal specimens from 5 positive patients confirmed by real-time PCR and 2 negative p

atients.

Result : Although this evaluation test was performed using the small number of specimens, STANDARD F COVID-19 Ag FI

A showed 100% of sensitivity and 100% of specificity

No.Target

InterpretationSTANDARD F COVID-19 Ag FIA

RemarkORF1ab(RdRp) E COI value Result

13 ND 36.6 Negative 0.71 Negative Accepted

14 ND ND Negative 0.89 Negative Accepted

15 22.2 18.2 Positive 39.23 Positive Accepted






STANDARD Q COVID-19 Ag | Performance

Test site : Seoul National University Bundang Hospital

Objective : Test for effectiveness evaluation of STANDARD Q COVID-19 Ag Test

Specimen Information : Nasopharyngeal specimens from 5 positive patients confirmed by real-time PCR and 2 negative p

atients.

Result : Although this evaluation test was performed using the small number of specimens, STANDARD Q COVID-19 Ag sh

owed 80% of sensitivity and 100% of specificity

No.Target

InterpretationSTANDARD Q COVID-19 Ag

RemarkORF1ab(RdRp) E Background Flow C Line T Line Result

13 ND 36.6 Negative Perfect Complete 3+ - Negative Accepted

14 ND ND Negative Perfect Complete 3+ - Negative Accepted

15 22.2 18.2 Positive Perfect Complete 3+ 2+ Positive Accepted




20 23.2 23.0 Positive Perfect Complete 3+ - Negative Accepted


STANDARD Q COVID-19 IgM/IgG Duo | PerformanceTest site : Medical center in Wuhan, China.

Objective : Test for effectiveness evaluation of STANDARD Q COVID-19 IgM/IgG Duo Test

Specimen Information : Paired sera specimens collected from 40 patients who came to the hospital with respiratory or pn

eumonia symptoms.

Result :

The IgM test result of the specimens collected within 7 days from the initial PCR confirmation was as follows

7 days after initial PCR confirmed

PCRTotal

Positive Negative

COVID-19IgM

Positive 22 0 22

Negative 2 16 18

Total 24 16 40

Sensitivity : 91.7%, Specificity : 100%



PCRTotal

Positive Negative

COVID-19IgM

Positive 24 0 24

Negative 0 16 16

Total 24 16 40

Sensitivity : 100%, Specificity : 100%



PCRTotal

Positive Negative

COVID-19IgG

Positive 19 0 19

Negative 5 16 21

Total 24 16 40

Sensitivity : 79.2%, Specificity : 100%



PCRTotal

Positive Negative

COVID-19IgG

Positive 24 0 24

Negative 0 16 16

Total 24 16 40

Sensitivity : 100%, Specificity : 100%


Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA [email protected] | www.sdbiosensor.com

Thank YouSD BIOSENSOR, Inc.

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