Precision Diagnosis
We carry out research and develop precision diagnostic products based on next-generation sequencing (NGS) technology and supply commercialized products to a number of major hospitals in Korea.
We are striving to lead the precision diagnostics market by providing diagnostic solutions for the entire cancer treatment cycle, from early diagnosis to prognosis/companion diagnosis, and post-operative monitoring and testing.
BRCAaccuTest™ &
BRCAaccuTest™ PLUS
This is an NGS-based precision diagnostic panel that can perform BRCA1/2 genetic testing of hereditary breast and ovarian cancer patients.
- Plus product: Product with better analysis features such as target area expansion and data uniformity for CNV* detection
- *CNV: Copy Number Variation
NGS-based breast/ovarian cancer genome analysis precision diagnosis
BRCAaccuTest™ PLUS helps early diagnosis and optimal treatment through the NGS-based precise examination of BRCA gene variations that may cause breast cancer or ovarian cancer.
- Cancer types to which BRCAaccuTest™ PLUS is applicable
- Breast cancer/ovarian cancer
Korea’s first product certified by Korea Ministry of Food and Drug Safety and CE-IVD
It is the first in Korea to be approved as a grade 3 in vitro diagnostic medical device by Korea Ministry of Food and Drug Safety and CE-IVD certified for the first time in Asia, ensuring safety.
- BRCAaccuTest™ · CE-IVD certification: June 2016 · Licensed by Korea Ministry of Food and Drug Safety: December 2017
- BRCAaccuTest™ PLUS · CE-IVD certification: February 2018 · Licensed by Korea Ministry of Food and Drug Safety: August 2021
Combination with genome big data automatic analysis software
BRCAaccuTest™ PLUS may be used in combination with ‘NGeneAnalySys’ which is a genome big data auto analysis software program. NGS data produced from test reagents are applied to the bioinformatics pipeline, and all the steps from auto-analysis to reading and test sheet preparation are implemented in the one-stop process.
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Data analysis time reduction
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The self-developed biological data analysis pipeline is applied.
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The auto-analysis method checks the list of multiple variants and the clinical importance of each of them
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Clinical report preparation and printing
Workflow
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Genomic DNA
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Target region
amplification -
Adapter ligation
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Amplification
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Next Generation
Sequencing -
NGS Data Analysis &
Create Clinical Reports
Product specification
| BRCAaccuTest™ PLUS | BRCAaccuTest™ | |
|---|---|---|
| Certification |
Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 21-706) CE-IVD RUO* |
Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 17-983) CE-IVD |
| Compatible platforms | Illumina / MiSeq*, MiSeq Dx, MiniSeq*, iSeq* | Illumina / MiSeq*, MiSeq Dx |
| Target enrichment | Amplicon method | |
| Specimen | Blood, FFPE* or tissue biopsy* | Blood |
| Target genes | BRCA1 and BRCA2 | |
| Sequencing reagent and throughput |
24 tests/kit - Germline: 1 runs up to 24 samples - Somatic: 1 runs up to 6 samples |
24 tests/kit Germline: 1 runs up to 24 samples |
| Target region | all protein coding regions, splicing regions, selected promoter, UTR, intron regions |
all protein coding regions, splicing regions |
| Target size | 22.4 kb (amplicon: 2 pools) | 19.8 kb |
| Turn around time | < 5 hrs | |
| Variants type | SNV, INDEL, Dup, CNV* | SNV, INDEL |
| Analysis solution | NGeneAnalySys™ | |
**CNV: Copy Number Variation
HEMEaccuTest™
This is a precision diagnosis panel to detect major genetic variations related to malignant tumors in blood using NGS technology.
NGS-based blood cancer genome analysis precision diagnosis
HEMEaccuTest™ is an NGS-based diagnosis method designed to detect variants in more than 100 genes related to malignant tumors in blood, hemopoietic organs, lymph nodes, and lymph systems and to help patients select the optimal treatment method and therapy.
- Cancer types to which HEMEaccuTest™ is applicable
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Acute Myeloid Leukemia(AML), Acute Lymphocytic Leukemia(ALL), Myelodysplastic/Myeloproliferative Neoplasms(MDS/MPN), Multiple Myeloma(MM), Lymphoma
CE-IVD certification
For the first time in Korea, the European in-vitro diagnostic device certification CE-IVD was obtained, proving its safety.
- · HEMEaccuTest™ : November 2018 (CE-IVD)
Combination with genome big data automatic analysis software
HEMEaccuTest™ may be used in combination with ‘NGeneAnalySys’ which is a genome big data auto analysis software program. NGS data produced from test reagents are applied to the bioinformatics pipeline, and all the steps from auto-analysis to reading and test sheet preparation are implemented in the one-stop process.
-
Data analysis time reduction
-
The self-developed biological data analysis pipeline is applied.
-
The auto-analysis method checks the list of multiple variants and the clinical importance of each of them
-
Clinical report preparation and printing
HEMEaccuTest™
DNA Workflow
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gDNA Prep
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DNA Shearing
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Library Prep
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Target hyb & Capture
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Final Amplification
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Next Generation
Sequencing -
NGS Data Analysis &
Create Clinical Reports
HEMEaccuTest™
RNA Workflow
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Total RNA Prep&
rRNA Depletion -
cDNA Synthesis
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Library Prep
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Target hyb & Capture
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Final Amplification
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Next Generation
Sequencing -
NGS Data Analysis &
Create Clinical Reports
Product specification
| HEMEaccuTest™ DNA | HEMEaccuTest™ RNA | |
|---|---|---|
| Certification |
Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 20-398) CE-IVD RUO* |
RUO* |
| Compatible platforms | Illumina / MiSeq, MiSeq Dx | |
| Target enrichment | Targeted sequencing / Hyb & capture method | |
| Specimen | Blood, bone marrow and lymph nodes | |
| Quantity | 96 tests/kit (8 runs per kit, up to 12 samples per run) | |
| Target genes | 108 genes | 53 genes |
| Target size | 305 kb | 158 kb |
| Turn around time | 2 ~ 3 days | 2.5 ~ 3.5 days |
| Variants type | SNV, INDEL | SV(fusion) |
| Analysis solution | NGeneAnalySys™ | |
ONCOaccuPanel™
It is a precision diagnostic panel that can be used to test for major genetic mutations related to solid tumors using NGS.
Guidance for cancer treatment based on NGS-based precision diagnostics
ONCOaccuPanel™ was jointly developed by Seoul Asan Medical Center and Harvard Dana-Farber Research Center after technology transfer and commercialization. This method makes it possible to test more than 300 genetic mutations from tissue specimens of solid cancer (around 35 cancer types including lung, colon, stomach, breast cancer, etc.).
CE-IVD certification and Ministry of Food and Drug Safety certification examination underway
As an NGS-based pan-cancer genetic testing product, ONCOaccuPanel™ is being reviewed by the Ministry of Food and Drug Safety for approval as Class III in vitro diagnostic medical device, while its safety has been verified with CE-IVD certification in Europe. Furthermore, its applications are being expanded to include companion diagnostics such as targeted therapy and immunotherapy.
Can be used in combination with automated genome big data analysis software
ONCOaccuPanel™ can be used in combination with NGeneAnalySys, automated genome big data analytics software. It is designed to apply and automatically analyze the NGS data using the bioinformatics pipeline and issue a clinical report in a streamlined process.
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Reduced data analysis time
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Application of bioinformatics analysis pipeline developed in-house
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Verification of a list of diverse variations and clinical significance through automatic analysis
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Preparation of clinical reports tailored to user needs
ONCOaccuPanel™
Workflow
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gDNA Prep
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DNA Shearing
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Library Prep
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Target hyb & Capture
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Final Amplification
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Next Generation
Sequencing -
NGS Data Analysis &
Create Clinical Reports
Product specification
| ONCOaccuPanel™ | |
|---|---|
| Certification | CE-IVD RUO* |
| Compatible platforms | Illumina / MiSeq*, MiSeqDx, NextSeq 550*, NextSeq 550Dx |
| Target enrichment | Hyb & capture method |
| Specimen | FFPE, tissue biopsy (Optimal tumor % : >30%) |
| Quantity | 60 tests/kit (4 runs per kit, up to 15 samples per run) |
| Target genes | 344 genes |
| Target region | Entire coding exon(CDS): 244 genes Partial exon / Hot spot: 100 genes |
| Target size | 1.29 Mb |
| Turn around time | 2 ~ 3 days |
| Variants type | SNV, INDEL, CNV, SV(Fusion)*, TMB*, MSI* |
| Analysis solution | NGeneAnalySys™ |
*RUO: Reseach Use Only
SOLIDaccuTest™
It is a precision diagnostic panel that can be used to test for major genetic mutations related to solid tumors using NGS.
Guidance for cancer treatment based on NGS-based precision diagnostics
SOLIDaccuTest™ can simultaneously test for mutations in about 100 genes associated with major types of cancer such as lung cancer, colorectal cancer, gastrointestinal cancer, and breast cancer based on NGS. By providing optimal targeted therapy information, it allows medical professionals to make patient-specific diagnoses.
Korea's first NGS precision diagnostic product to obtain CE-IVD certification
The safety of SOLIDaccuTest™ has been proven with the CE-IVD certification, as Korea’s first NGS-based in vitro diagnostic medical device for solid tumor to be certified in Europe.
- · SOLIDaccuTest™ DNA : February 2020
Can be used in combination with automated genome big data analysis software
SOLIDaccuTest™ can be used in combination with NGeneAnalySys, automated genome big data analytics software. It is designed to apply and automatically analyze the NGS data using the bioinformatics pipeline and issue a clinical report in a streamlined process.
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Shortened data analysis time
-
Application of an In-house bioinformatics analysis pipeline
-
Verification of a list of diverse variations and clinical significance through automatic analysis
-
Preparation of clinical reports tailored to user needs
SOLIDaccuTest™
DNA Workflow
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gDNA Prep
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DNA Shearing
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Library Prep
-
Target hyb & Capture
-
Final Amplification
-
Next Generation
Sequencing -
NGS Data Analysis &
Create Clinical Reports
SOLIDaccuTest™
RNA Workflow
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Total RNA Prep &
rRNA Depletion -
cDNA Synthesis
-
Library Prep
-
Target hyb & Capture
-
Final Amplification
-
Next Generation
Sequencing -
NGS Data Analysis &
Create Clinical Reports
Product specification
| SOLIDaccuTest™ DNA | SOLIDaccuTest™ DNA HRD | SOLIDaccuTest™ RNA | |
|---|---|---|---|
| Certification |
Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 20-397) CE-IVD RUO* |
Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 21-253) RUO* |
RUO* |
| Compatible platforms | Illumina / MiSeq*, MiSeqDx | ||
| Target enrichment | Hyb & capture method | ||
| Specimen | FFPE, tissue biopsy (Tumor %; > 20%) | ||
| Quantity | 96 tests/kit (8 runs per kit, up to 12 samples per run) | ||
| Target genes | 84 genes | 111 genes | 29 genes |
| Target size | 270 kb | 330 kb | 80 kb |
| Turn around time | 2 ~ 3 days | 2.5 ~ 3.5 days | |
| Variants type | SNV, INDEL, CNV** | SV(fusion) | |
| Analysis solution | NGeneAnalySys™ | ||
**CNV: Copy Number Variation
HLAaccuTest™ /
HLAaccuTest™ All
DNA extracted from the blood of transplant donors or recipients is tested by NGS, and among histocompatibility antigens, HLA-A, -B, -C, -DRB1, -DQB1, DRB 3/4/5, DQA1, DPA1, DPB1 etc are analyzed. It is a precision diagnostic panel that helps select the optimal donor by identifying alleles at high resolution
NGS-based histocompatibility test
In order to minimize side effects of organ and bone marrow transplantation, precedent histocompatibility genetic testing is performed using NGS technology. Simultaneously identifies 5 or 11 loci at high resolution to help select optimal donors.
Ministry of Food and Drug Safety approval and CE-IVD certification
Received approval from the Ministry of Food and Drug Safety for Class 3 in vitro diagnostic medical devices and CE-IVD certification.
- · HLAaccuTest™ : May 2021 (MFDS)
- · HLAaccuTest™ All : November 2021 (CE-IVD)
Can be used in combination with histocompatibility gene antigen typing analysis software
HLAaccuTest™ can be used in combination with ‘EasyHLAanalyzer’, a histocompatibility analysis software. NGS data from tested reagents is analyzed automatically. Including the reading and clinical report preparation, all the steps are implemented in a one-stop process.
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Auto-analysis based on the IMGT/HLA database
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Application of a self-developed bioinformatical analysis pipeline
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Data visualization using various tables
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Clinical report preparation and printing
Workflow
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Genomic DNA
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LR-PCR
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Pooling
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Fragmentation
& End repair -
Adapter ligation
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Indexing PCR
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Sequencing
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Analysis
Product specification
| HLAaccuTest™ | HLAaccuTest™ All | |
|---|---|---|
| Certification | Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 21-361) |
Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 21-461) CE-IVD RUO* |
| Compatible platforms | Illumina / MiSeq Dx | |
| Target enrichment | Targeted sequencing / Amplicon method (Long-range PCR) | |
| Specimen | Blood (input DNA conc. 50~100 ng/locus) | |
| Quanity |
96 tests/kit MiSeq Reagent Nano Kit, v2: Nano 16 samples, minimum 500X/locus |
96 tests/kit MiSeq Reagent Nano Kit, v2: 6 samples, minimum200X/locus MiSeq Reagent Micro Kit: 24 samples, minimum200X/locus |
| Target HLA locus | Class I: A, B, C Class II: DRB1, DQB1 |
Class I: A, B, C Class II: DRB1/3/4/5, DQA1, DQB1, DPA1, DPB1 |
| Target region | A, B, C / DQB1: entire exon & intron region DRB1: exon 2, 3, 4 & intron region |
A, B, C / DQA1, DQB1, DPA1, DPB1: entire exon & intron region DRB1/3/4/5: exon2, 3, 4 & intron region |
| Target size | 21.6 kb | 55.6 Kb |
| Turn around time | 9~11 hrs (hands-on time: 3~4 hrs) | |
| Analysis solution | EasyHLAanalyzer™ | EasyHLAanalyzer™ * |