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  • Oncology-Related Genetic Assay Kits
BioSewoom introduces its products developed through continuous research and innovation.
IVD Product License No: 12-1736
(Korea MFDS)
Real-Q TH Quantification Kit
IVD Product License No: 12-1757
(Korea MFDS)
Real-Q JAK2 V617F Kit
IVD Product License No: 12-1758
(Korea MFDS)
Real-Q BRAF V600E Detection Kit
IVD Product License No: 12-1761
(Korea MFDS)
Real-Q BCR-ABL Quantification Kit
IVD Product License No: 12-1762
(Korea MFDS)
Real-Q AML1-ETO Quantification Kit
IVD Product License No: 12-1764
(Korea MFDS)
Real-Q NPM1-mutA Quantification Kit
IVD Product License No: 12-1770
(Korea MFDS)
Real-Q JAK2 V617F Quantification Kit
IVD Product License No: 12-1785
(Korea MFDS)
Real-Q PML-RARa Quantification Kit
IVD Product License No: 15-1180
(Korea MFDS)
Real-Q EGFR Mutation Detection Kit
IVD Product License No: 15-1252
(Korea MFDS)
Real-Q KRAS Mutation Detection Kit

IVD Product License No: 12-1736 (Korea MFDS)

Real-Q TH Quantification Kit

Intended Use

The Real-Q TH (Tyrosine Hydroxylase) Quantification Kit is an in vitro diagnostic medical device designed to quantitatively detect tyrosine hydroxylase (TH) from cDNA derived from total RNA or mRNA extracted from human whole blood or bone marrow.

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Quantification using TH and ABL standard materials
  • Relative quantification using ABL gene as a normalizer
  • Positive control included to verify assay accuracy

Specimen Types

Whole blood, Bone Marrow

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (TH standard 1~4)
Amplification curve (ABL standard 1~4)

IVD Product License No: 12-1757 (Korea MFDS)

Real-Q JAK2 V617F Kit

Intended Use

The Real-Q JAK2 V617F Kit is an in vitro diagnostic medical device that qualitative detection the JAK2 V617F mutation in exon 14 of the JAK2 gene from DNA extracted from human blood using Real-Time PCR.

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Internal control ensures validation from nucleic acid extraction to amplification

Specimen Type

Whole Blood

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (Positive control)

IVD Product License No: 12-1758 (Korea MFDS)

Real-Q BRAF V600E Detection Kit

Intended Use

The Real-Q BRAF V600E Detection Kit is an in vitro diagnostic medical device designed to detect the BRAF V600E mutation in DNA extracted from human thyroid tissue using Real-time PCR

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Internal control ensures validation from nucleic acid extraction to amplification

Specimen Types

Thyroid stained slide, fresh tissue, FNAB, FFPE tissue

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (Positive control)

IVD Product License No: 12-1761 (Korea MFDS)

Real-Q BCR-ABL Quantification Kit

Intended Use

Real-Q BCR-ABL Quantification Kit is an in vitro diagnostic medical device designed for the quantitative detection of BCR-ABL fusion gene in cDNA derived from total RNA or mRNA extracted from human whole blood or bone marrow, using real-time quantitative PCR

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Quantitative analysis using BCR-ABL and ABL standard materials
  • Relative quantification using the ABL gene as a normalizer
  • Provision of a positive control to verify the accuracy of the test

Specimen Types

Blood cells, Bone Marrow

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (BCR-ABL standard 1~4, NIBSC panel)
Amplification curve (ABL standard 1~4, NIBSC panel)

IVD Product License No: 12-1762 (Korea MFDS)

Real-Q AML1-ETO Quantification Kit

Intended Use

Real-Q AML1-ETO Quantification Kit is an in vitro diagnostic device for quantitative detection of AML1-ETO fusion gene in cDNA derived from total RNA or mRNA extracted from mononuclear cells (MNC) of human whole blood or bone marrow using real-time quantitative PCR

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Quantitative analysis using AML1-ETO and ABL standard materials
  • Relative quantification using the ABL gene as a normalizer
  • Provision of a positive control to verify the accuracy of the test

Specimen Types

Whole blood, Bone Marrow

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (AML1-ETO standard 1~4l)
Amplification curve (ABL standard 1~4)

IVD Product License No: 12-1764 (Korea MFDS)

Real-Q NPM1-mutA Quantification Kit

Intended Use

Real-Q NPM1-mutA Quantification Kit is an in vitro diagnostic medical device designed to quantify NPM1 gene mutation type A [TCTG insertion at exon 12, position nt960] in cDNA derived from total RNA or mRNA extracted from human whole blood using real-time quantitative PCR

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Quantitative analysis using NPM1-MutA and ABL standard materials
  • Relative quantification using the ABL gene as a normalizer
  • Provision of a positive control to verify the accuracy of the test

Specimen Types

Whole blood

Compatible Instruments

  • AB7500 / AB7500 fast

Result

Amplification curve (NPM1-MutA standard 1~4)
Amplification curve (ABL standard 1~4)

IVD Product License No: 12-1770 (Korea MFDS)

Real-Q JAK2 V617F Quantification Kit

Intended Use

Real-Q JAK2 V617F Quantification Kit is an in vitro diagnostic medical device intended for quantitative detection of the JAK2 exon 14 mutation (JAK2 V617F) in DNA extracted from human blood, using real-time quantitative PCR

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Quantitative analysis using JAK2 V617F and WT standard materials

Specimen Type

Whole blood

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (JAK2 V617F standard 1~4, sample DNA)
Amplification curve (JAK2 WT standard 1~4, sample DNA)

IVD Product License No: 12-1785 (Korea MFDS)

Real-Q PML-RARa Quantification Kit

Intended Use

Real-Q PML-RARa Quantification Kit is an in vitro diagnostic medical device designed for quantitative detection of the PML-RARa fusion gene in cDNA derived from total RNA or mRNA extracted from mononuclear cells (MNC) isolated from human whole blood or bone marrow, using real-time quantitative PCR

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Quantitative analysis using PML-RARa and ABL standard materials
  • Relative quantification using the ABL gene as a normalizer
  • Provision of a positive control to verify the accuracy of the test

Specimen Types

Whole blood, Bone Marrow

Compatible Instruments

  • CFX96 / CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (PML-RARa standard 1~4)
Amplification curve (ABL standard 1~4)

IVD Product License No: 15-1180 (Korea MFDS)

Real-Q EGFR Mutation Detection Kit

Intended Use

EGFR Mutation Detection Kit is an in vitro diagnostic medical device for somatic mutation detection of EGFR (including EGFR 18 G719X, EGFR 19 deletions, EGFR 20 S768I, T790M, insertions, and EGFR 21 L858R, L861Q) using real-time PCR from DNA extracted from formalin-fixed paraffin-embedded (FFPE) and fresh lung cancer tissues, aiding molecular genetic diagnosis of lung cancer

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Provided in strip tube format with all reagents pre-dispensed for the assay
  • Internal control(EGFR gene) ensures validation from nucleic acid extraction to amplification

Specimen Types

FFPE tissue, Fresh tissue

Compatible Instruments

  • CFX96/CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (EGFR21 L858R mutant sample DNA)
Amplification curve (EGFR 19 deletions mutant sample DNA)

IVD Product License No: 15-1252 (Korea MFDS)

Real-Q KRAS Mutation Detection Kit

Intended Use

KRAS Mutation Detection Kit is an in vitro diagnostic medical device designed to detect KRAS gene mutations at Codons 12 (G12S, G12R, G12C, G12D, G12A, G12V) and 13 (G13D) from DNA extracted from FFPE and fresh colon cancer tissues using real-time PCR, supporting molecular genetic diagnosis of colorectal cancer

Product Features

  • High sensitivity, specificity, and reproducibility using multiplex real-time PCR
  • Prevents carryover contamination with Uracil-N-glycosylase (UNG) method
  • Convenient data analysis using BioSewoom Viewer software
  • Provided in strip tube format with all reagents pre-dispensed for the assay
  • Internal control(KRAS gene) ensures validation from nucleic acid extraction to amplification

Specimen Types

FFPE tissue, Fresh tissue

Compatible Instruments

  • CFX96/CFX96DX
  • AB7500 / AB7500 fast

Result

Amplification curve (G12S mutant sample DNA)
Amplification curve (G12D mutant sample DNA)
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