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SEASUN
BIOMATERIALS

www.seasunbio.com
 SEASUN Contents
BIOMATERIALS
Ⅰ. Overview
Ⅱ. Diagnostic platform & Technology
Ⅲ. Products information
IV. Conclusion
Overview

“SEASUN BIOMATERIAL Inc. is a company that develops molecular diagnostic platforms for
Companion diagnostics and Personalized medicine to realize Precision medical care”

CEO HeeKyung Park

09 CE marked (U-TOP MSI) 04 launching a prenatal test service (Mom’s seasun)
Date of 08 Approved by the MFDS (U-TOP MSI) 04 Registration of original patent (U-TOP MSI)
Establishment
March 20, 2012
2017 2019
Product IVDs (In-vitro diagnostic devices)

Location Headquarters / Labㅣ 2012-16 2018 2020

N517, 11-3, Techno 1-ro, Yuseong-gu,
Daejeon, Korea 12.03 SEASUN BIOMATERIALS, 04 launching a personal genome analysis service 02 Approved by the MFDS(Patio NIPT)
Inc. is founded (Gene’s eye) 02 Approved by the MFDS (U-TOP HL P2)
Sales Departmentㅣ 13.11 Established Research Institute 06 Approved by the MFDS (U-TOP HPy-ClaR) 03 Approved by The CE (U-TOP COVID-19)
103-903, 67, Seobinggo-ro, 16.01 Approved by the MFDS 08 Additional permission of gastric cancer
Yongsan-gu, Seoul, Korea (U-TOP MSI)
(U-TOP HL)
16.09 Obtained GMP Certification 08 Obtained ISO9001 Certification
Website www.seasunbio.com
16.10 Obtained ISO13485 Certification 11 Approved by the MFDS (U-TOP CMV)
12 Approved by the MFDS (U-TOP DEP)
12 Signed MOU with GSBIO of China
Diagnostic Platform

“Simple & Rapid Analysis based on Real-time PCR”

Chromosome aberration DNA mutation DNA methylation Multi-target Detection

01 PatioTM 02 U-TOPTM 03 Epi-TOPTM 04
ID-CodeTM

M Gene A A A G C T T A A
e T T C G A A T T

A T G C T T A A A A G C T T A A
T A C G A A T T T T C G A A T T Gene B A
T
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G
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G
T
A
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M
e Gene C A A G C T T A A
SNP T T C G A A T T

Gene D A
T
A
T
G
C
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A T G C T T A A
T A C G C A T T

…
Chromosome aberration analysis Mutation analysis (SNP, Indel, CNV) Epigenetic technology Multi-target simultaneous diagnosis

stable technology using blood 16 genotypes per well No required bisulfite treatment Multi detection with 1 probe

Detection of fetal DNA High Sensitivity & Reproducibility Diagnosis/treatment monitoring Gene expression (miRNAs…)
Diagnostic Products
“All products is approved by South Korea MFDS”

Prenatal & Newborn Care Early Detection & prognosis of Cancer

Prenatal Test Microsatellite Instability (MSI) Test

(Colon, gastric, and endometrial cancer)

“Korean World-class
Product Award 2019”
PatioTM DEP Detection Kit PatioTM NIPT Detection Kit
U-TOPTM MSI Detection Kit

Congenital Hearing Loss

H. pylori infection &
COVID-19 infection
Clarithromycin resistance Test

U-TOPTM HL Genotyping Kit U-TOPTM CMV U-TOPTM CMV U-TOPTM HPy-ClaR Detection Kit U-TOPTM COVID-19 Detection Kit
Detection Kit Quantification Kit
Diagnostic Products

“Development of a licensed product based on clinical verification

and Proceed inspection service”
IVD / CE marked Clinical trial Service

Genetic Disorders & Infection Proceed in Mom’s SEASUN

Congenital hearing loss (HL)
- U-TOPTM HL P1 (Inherited HL)
- U-TOPTM HL P2(Inherited HL)
- U-TOPTM CMV (Virus affected HL)
Fetal chromosomal abnormalities
- PatioTM NIPT (noninvasive prenatal test)
- PatioTM DEP (Amniocentesis)
Virus infection disease
- U-TOPTM COVID-19 Detection Kit
Cancer Genome
: prenatal Genetic Service
- Iso-TOPTM COVID-19 Detection Kit
(POCT detection Kit)
- Iso-TOPTM Influenza A/B Detection Kit
(POCT detection Kit)
Gene’s eye
- U-TOPTM MSI plus (blood)
: Personal Genetic Service
- Epi-TOPTM mMGMT (Glioblastoma)
- Epi-TOPTM Early colon (Colon cancer)
- Epi-TOPTM MLH1
- Epi-TOPTM PDL-1
- ID-CodeTM IgH Detection (blood cancer)

Screening / Prediction of Drug Response

- U-TOPTM MSI
(Colon, Gastric, Endometrial, Ovary cancer)
- U-TOPTM Hpy-ClaR
(H. pylori infection & antibiotic resistance)
Agency Certification
R&D Certificate of company
Department Certificate affiliated research institute

GMP ISO13485 ISO9001

Certification and Approval of medical devices

1 2 3 4 5

U-TOPTM HL U-TOPTM MSI U-TOPTM MSI U-TOPTM HPy U-TOPTM HPy

hereditary hearing loss Colorectal cancer Colorectal cancer Helicobacter pylori Helicobacter pylori
2016. 01. 06 (MFDS) 2017. 08. 23 (MFDS) 2017. 09. 01 (CE-IVD) Infection & Clarithromycin Infection & Clarithromycin
resistance Test resistance Test
2018. 06. 19 (MFDS) 2018. 08. 25 (CE-IVD)
6 7 8 9 10

U-TOPTM MSI U-TOPTM CMV U-TOPTM CMV PatioTM DEP PatioTM NIPT
Gastric cancer CMV Detection CMV Quantification Prenatal Test (Amniocentesis) Prenatal Test (Mother’s blood)
2018. 08. 25 (MFDS) 2018. 11. 13 (MFDS) 2018. 11. 13 (MFDS) 2018. 12. 28 (MFDS) 2018. 12. 28 (MFDS)
Patient

# Title registration date patent number

1 brand name “MeltingArray” 2014.09.03 40-1058753 - Application: 19

2 Method of preparing metagenomic library by inhibiting amplification of target microbial species using PNA probe 2016.03.30 10-1609295

3 (Method for the Determination of Blood Typing Using PNA Probe and fluorscence melting curve analysis 2017.01.05 10-1695477
- Registration: 20
Method of Solving Nucleic Acid Detection Problem Based on Threshold Cycle(Ct) of Polymerase Chain Reaction
4 2018.03.28 10-1845043
Using Peptide Nucleic Acid Probe)

5 Kit for gender determination 2018.04.04 10-1847634

Peptide nucleic acid probe for multiplex-detecting BCR/ABL negative MPN related gene mutations, composition for
6 multiplex-detecting gene mutation there of, gene mutation detecting multiplex kit and gene mutation detecting 2019.02.22 10-1953092
multiplex methods

7 Peptide nucleic acid(PNA) probe for detecting hereditary hearing loss and detection method using the same 2019.05.30 10-1986193

Development of real-time PCR using PNA probe for detection of Viral Hemorrhagic Septicemia Virus (VHSV) and
8 2017.09.21 10-1782489
Uses Thereof

9 Method for Determining Nucleotide Sequence Identity Using Probe and Melting Profile Analysis 2018.09.06 10-1898258

Melting Curve Analysis Using bifunctional PNA probe for Microsatellite Instability (MSI) Diagnosis, and Method and
10 2019.04.11 10-1969971
Kit of Microsatellite Instability Diagnosis Using the Same

Method for Detecting Chromosomal Numeric Abnormality based on Elimination Probe and Composition for
11 2019.05.14 10-2079963
Detecting Chromosomal Numeric Abnormality

12 (Method, kits and PCR device for detecting methylation of gene using reduction probe 2019.05.31 10-2019800
MOU and External Awards

MOU

Social welfare organizations Global equipment manufacturers Bioinformatics / AI development company

Award &
Commendation

2019 World-class Product Award Awarded commendation Medical Consumer Satisfaction awards
(Ministry of Trade, Industry and Energy)
Product promotion

Promotion of Conferences and Exhibitions News

New office building

◎ location : 1004-5, Guryongdaljeon-ro, Yuseong-gu, Daejeon, Korea

◎ land area : 11,227m2

◎ Building area : 4,440m2

1) 1st floor: 4,440m2

2) 2nd floor : 4,440m2