BODITECH MED INC.

WORLD MARKET LEADER for IVD

2

Company overview

400

employees

7

Companies one family

120

Distribution countries

>50,000

Devices installedworldwide

80 Million

Cartridges per year

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Quality system

Area Certi./Accreditation

Korea KGMP

Japan

Accreditation certificate of foreign medical devicemanufacturer

Accreditation certificate of foreign in vitro diagnostic manufacturer

Common

EN ISO 13485:2012+AC:2012

DIN EN ISO 13485:2012

MDSAP

NGSP HbA1c for ichroma, ichroma II, AFIAS-1, and AFIAS-50

Country Korea EU US CHINA JAPAN BRAZILAUSTRALIA

MOH MFDS CE FDA CFDA PMDA ANVISA TGA

Analyzer 12 12 3 5 2 2 2

Reagent 167 168 24 19 2 15 25

Registered items

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▪ CK-MB▪ D-Dimer▪ hsCRP▪ Myoglobin▪ Troponin-I▪ NT-proBNP▪ Cardiac Triple▪ ST2*

▪ TSH▪ T3▪ T4▪ FSH▪ bhCG▪ PRL▪ LH▪ Cortisol▪ Testosterone▪ Progesterone

▪ AFP▪ CEA▪ PSA

▪ Cystatin C▪ HbA1c▪ MAU

▪ CRP▪ PCT▪ ASO▪ Dengue NS1▪ Dengue

IgM/G▪ HBsAg▪ Anti-HBs▪ Anti-HCV▪ HIV Ag/Ab▪ Zika IgG/IgM▪ TB (IGRA)*

▪ Vitamin D▪ Ferritin

▪ Noro▪ Rota▪ Rota/Adeno▪ H.Pylori Ag▪ Calprotectin▪ iFOB▪ iFOB/Calp

Combo

▪ Influenza A+B▪ Influenza/RSV▪ Strep A*▪ RSV*▪ Mycoplasma*

Diabetes

Other

Infectious

Cardiac

CancerImmune

Respiratory

Hormone

Gastro-Intestine

Boditech

Ichroma-50

Ichroma II

AFIAS-6

AFIAS-1

Ichroma M

TRIAS

Hemo-chroma

Plus

IRIS-3

▪ RF IgM▪ Anti-CCP▪ IgE

COVID-19 Antibody testPART 3

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• Coronavirus is RNA virus with 27-32 kb genome and can infect human, bat, birds, and other

animals

• 4 coronavirus subtypes (Alpha, Beta, Delta, Gamma)

• Alpha, Beta: found in human, other animals

• Delta, Gamma: found in animals

• A novel coronavirus (nCoV) is a new strain that has not been previously identified in humans

and causes COVID-19 disease.

• Clinical symptoms including fever, coughing sneezing, and pneumonia.

Coronavirus

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Human Coronavirus

There are seven strains of human coronaviruses

SARS-CoV-2

HCoV-229E HCoV-OC43 HCoV-OC43 HKU1

SARS-CoV MERS-CoV

Common cold coronavirus

SARS-CoV, MERS-CoV

Novel coronavirus

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Covid-19 MERS SARS Common cold coronavirus

OriginFirst reported in December

2019 in Wuhan, China

First reported in 2012 in Saudi

Arabia

First reported in 2002

in southern China

Four coronavirus strains are

thought to be responsible for

15-30% of common cold

Trans-

mission

Likely from touching or

eating an infected, as yet

unidentified animal.

Human-to-human

transmission occurs through

close contact

Often from touching infected

camels or consuming their

milk or meat. Limited

transmission between

humans through close contact

Believed to have

spread from bats,

which infected civets.

Transmitted mainly

between humans

through close contact

Close contact with infected

humans or touching a

surface that carries the virus

CasesMore than 2.5Million

confirmed cases(2020.4.22)

1-10% mortality

2,494 confirmed cases; 858

deaths(as Nov. 30, 2019)

Mortality rate of 34%

8,098 cases; 774

deaths. Mortality rate

of about 10%

Millions each year. Generally

nonlethal with rare

exceptions.

Current

Status

Cases reported mainly in

China and spreading over

the world

All cased lined to Arabian

Peninsula. Others in 12

countries and death have

been declining since 2016

No new cases reported

since 2004. 87% of

previous cases in China

and Hong Kong

Circulates year-round, but

more common in fall/winter

Coronavirus Comparisons

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Symptoms of Coronavirus infection

Severe symptoms

Common symptoms

High fever(40oC or more)

Pnuemonia

Kidney failure

Fever

Dry cough

Mild breathing difficulty

Gastrointestinal issues

Diarrhea

General body aches• Hemagglutination

• Cardiac problem

• Neuronal damage

• Kawasaki-like disease

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COVID-19 Test window

PCR

Antibody test

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TestType of sample

Comments

Molecular Diagnosis

Nucleic acid amplification & Sequencing

Respiratory sample

Collect on presentation. Done by an expert laboratory. RT-PCR followed by sequencing if positive.

NAAT, Nucleic acid amplification

Collect on presentation. Done by an expert laboratory. Various PCR methods are under validation

Whole genome sequencingCollect on presentation. Done by an expert laboratory. Well quipped facility with long and costly testing

Immuno-assay

Serology Serum

IgG/IgM test in blood sample.Paired samples necessary for confirmation, the first sample collected in week 1 of illness and the second collected 2-3 weeks late

WHO Guideline for novel coronavirus diagnosis

Diagnosis of Coronavirus infection

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Detection rate 0-5.5 day 6-13 day >14 day

PCR > 90% 80 < 50 %

IgG/IGM ~ 75 % 75.6 ~ 93.1%

Detection rate by days

5.5 days after symptom onset, IgM/IgG detection rate is better than PCR positive rate and combine of PCR+IgM/IgG is best method

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RT-PCR Boditech Antibody test

ELISA(Antibody)

Rapid test(Antibody)

Target Virus (RNA) Antiviral IgM/IgG Antiviral IgM/IgG Antiviral IgM/IgG

Sample Nasopharyngeal/ oropharyngeal swab

Blood(WB/S/P) Blood(S/P) Blood(WB/S/P)

Sample hazard level

Highly contagious Low to non-contagious

Low to non-contagious

Low to no-contagious

Time(TOT) 1-6 hrs 10 min 3-4hrs 10-15 min

Sensitivity High High to medium High to medium Low

Testing windows Pre-symptom to onset of symptom

3-6 days after onset of symptom

3-6 days after onset of symptom

1 week after onset of symptom

Result Qualitative with Ct value

Qualitative with COI value

Quantitative Qualitative

Clinical value Confirmatory test Screening and monitoring of COVID-19

Screening and monitoring of COVID-19

Screening

Methods comparison

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Nine use cases for SARS-CoV-2 tests

USE CASE PCR Boditech/ELISA

Rapid

Ag Ab Ag Ab Ag

Triage of symptomatic individuals in an epidemic setting O O O ? O

Triage of symptomatic individuals in endemic settings O O O O

Triage of at-risk pre-symptomatic and symptomatic individuals in endemic settings O O O O

Confirmatory testing O

Diagnosis of symptomatic individuals in endemic or epidemic settings O O O ? O

Differential diagnosis in endemic or epidemic settings O O O ? O

Previous SARS-CoV-2 exposure O ?

Surveillance in sites of previous or potential outbreaks O O O O

Environmental monitoring O

Selection of convalescent person for plasma therapy O

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RT-PCR

Total

Positive Negative

Boditech COVID-19 Ab

Positive 46 0 46

Indetermidated 2 4 6

negative 0 131 131

Total 48 135 183

Percent postive agreement (%) = 95.8 %

Percent negative agreement (%) = 97.0 %

Overall percent agreement (%) = 96.7%

Clinical evaluation of Boditech COVID-19 Ab test

4.30 4.49 4.92

10.98

7.01

27.23

0.00

10.00

20.00

30.00

1 4 7

2.094.31

1.405.78

34.25 32.9028.60

32.80

0.00

10.00

20.00

30.00

40.00

1 3 5 9

IgM IgG

Example of IgM/IgG level in COVID-19 cases

0.20 0.10 0.20 1.40 0.90 0.900.15 0.00

8.05

25.90 25.4026.95

0.00

10.00

20.00

30.00

1 3 5 7 9 11

0.00 0.00 0.00 0.00 0.00

0.30

0.75

0.25

0.75

2.35

0.00

0.50

1.00

1.50

2.00

2.50

1 3 6 11 120.00 1.00 0.85

27.6529.75

26.10

0.00

10.00

20.00

30.00

1 3 4

Days after hospitalizationDays after hospitalization

COI COI

0.85 0.752.05

5.15 4.65 4.75

0.15 0.15 0.80

6.20

12.95

22.75

0.00

10.00

20.00

30.00

1 4 8 10 12 16

IgM IgG

Figure 1. Kinetics of IgG (left axis, empty circles, solid smoothing splines) and IgM (right axis, cross marks, dashed smoothing splines) according to days post symptom onset (PSO), considering 8 patients with COVID-19, using the AFIAS COVID-19 Ab (Boditech Med Inc., Chuncheon, Republic of Korea). IgM and IgG levels (through signal intensity, the cut-off index (COI)) rapidly increased after 9 d PSO. IgM antibody levels peaked at 20–24 d PSO and gradually decreased thereafter. IgG levels gradually increased and were maintained at similar levels after 25–29 d PSO.

Confidential The figure is the part of submitted scientific paper and should not be released until it is published.

Kinetics of IgM/IgG in COVID-19 patients

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19

Test procedure

1

2

3

4

Fingertip blood

Simple operation

Data collection by network

10 min result on site

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Reader Specification

Up to 30-40 test/hours Up to 5-6 test/hours Up to 24 test/hours

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Conclusion

• Superior Performance

➢ Percent positive agreement (%) = 95.8 %

➢ Percent negative agreement (%) = 97.0 %

➢ Overall percent agreement (%) = 96.7%

• Qualitative result with COI value (relative amount of IgM/IgG)

➢ Monitoring of patient with serial test

➢ Equal or better than ELISA (not rapid type)

• IgG level in convalescence patient

➢ Test for acquired immunity to COVID-19

➢ Plasma therapy purpose

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AFIAS/ichroma Antigen testViral antigen Immunofluorescence assay

✓ Antigen test(Immunofluorescence): practical alternative of PCR

✓ Antigen test AND antibody test will produce best result

✓ Test window covers most of infection AND convalescent period

An employee holds up an Ichroma Covid-19 Ab testing kit at the Boditech Med headquarters in

Chuncheon, South Korea. Bloomberg

THANK YOUBODITECH MED INC.sales@boditech.co.kr

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PCR practical issues

⚫ Sampling issues

- CDC recommend nasopharyngeal AND oropharyngeal swab.

nasopharyngeal sampling requires some training and common cause of

false negative

- It is reported that during nasopharyngeal swab sampling, candidates

often sneezing or coughing, which is potential hazard for the health

worker.

- Sample is biosafety level 2 but SARS-Cov-2 virus is biosafety level 3. Thus,

during transport and extraction (until it completed and collect RNA of

virus). It need to be treated as biosafety level 3 and extreme caution.

- Virus is liable in even in protective solution(VTM). 3-4 hours at RT and 24

hours at refrigerated. Sample transfer from collection site to Lab for PCR

causes the false negative

Appendix 1

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PCR practical issues

⚫ Performing analysis ( virus RNA extraction and PCR amplification)

- As previously mentioned, extraction should be performed biosafety level 3 with

high level protection equipment. It requires well trained person. Also prolonged

working at BL3 environment gives burden and easily slow down performance.(It

is one of the bottleneck of PCR procedure)

- In case different lab uses different PCR device, it is hard to compare directly each

result

- PCR requires well trained person for the operation and result analysis.

→ In Korea, at least 2 independent PCR positive is required for COVID-19

Confirmation. Due to inconsistency of result, it is reported that 10 times of

independent PCR had been performed in one patient

- Contamination issues: lab test is performed a lot test, positive result tube

contains amplified (hundreds millions of copy) RNA and it is potential

contaminant of PCR device and Lab.

It is reported that several case of device contamination, which resulted false

positive (Pure water can produce positive PCR result)

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Impact factor=9.1

Results The median duration of IgM and IgA antibody detection were 5 days (IQR 3-6),

while IgG was detected on 14 days (IQR 10-18) after symptom onset, with a positive rate of

85.4%, 92.7% and 77.9% respectively. In confirmed and probable cases, the positive rates of

IgM antibodies were 75.6% and 93.1%, respectively. The detection efficiency by IgM ELISA

is higher than that of qPCR method after 5.5 days of symptom onset. The positive detection

rate is significantly increased (98.6%) when combined IgM ELISA assay with PCR for each

patient compare with a single qPCR test (51.9%).

Appendix 2

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IgG/A IgG

Detection rate

85.4 77.9%

Detectable Day*

Day 5IQR(3-6)

Day 14IQR(10-18)

*Day after symptom onsetPost symptom onset(POS)

Day IgG change IgG change

0-7 Base level Base level

8-14 Increased Increased

15-21 plateaued Increased

>21 plateaued plateaued

IgM and IgG characteristics

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Detection rate 0-5.5 day 6-13 day >14 day

PCR(single) > 90% 80 < 50 %

IgG/IGM ~ 75 % 75.6 ~ 93.1%

Detection rate by days

5.5 days after symptom onset, IgM/IgG detection rate is better than PCR positive rate

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Appendix 3Example of test result