Diagnostic Technology

Multivariate index assay to measure
7 lung cancer biomarkers · Provides lung cancer
risk index with its own algorithm

Applied technology

An In Vitro Diagnostic Multivariate Index Assay (IVDMIA)
to use multiple makers on blood to improve clinical performance of diagnosis

Although different biomarkers are currently on development,
separating one specific marker has limitations and one biomarker is not enough to diagnose a disease,
to predict the development, to prevent, and to treat a disease.
Through the recent development in bioengineering and information technology,
the IVDMIA, unlike conventional in vitro diagnostic tests that measure a single biomarker at a time,
measures multiple markers, which has improved diagnostic accuracy with algorithm analysis.

Aptamer

  • Aptamer, derived from Aptus which means “fit” in Latin
  • Single strand DNA/ RNA with high specificity and affinity that binds to target-molecule based on stable 3-dimentional structure

Multiplex assay

  • Measures different biomarkers simultaneously
  • Provides diagnostic information through algorithm analysis
  • Effective in diagnosis of disease that does not have validated one single marker

Analysis program (Algorithm)

  • Each biomarker to be combined with the operator’s status reflected
  • Provides one lung cancer risk index calculating 7 different values

Development process

Throughout total 4 years of development, two clinical trials have been conducted.
As Ministry of Food and Drug Safety approves the registration of the kit September 2017,
it became the world’s first lung cancer in vitro diagnostic kit using Aptamer.

2014

Discovery of biomarker proteins for lung cancer.

  • Clinical trial in the U.S. in 636 American patients.
  • Potential as Aptamer-based diagnostic kit confirmed

2015

Investigational clinical trial (Asan Medical Center) Algorithm development

  • 200 patients in Asan Medical center
  • 7 biomarkers developed
    EGFR1, SERPINA3, MMP7, C9, CRP, KIT, CA6
  • Better performance as a multivariate index assay compared to a single biomarker confirmed - cancer

growth-related proteins

immune-related proteins

2016

Confirmatory trial (Asan Medical Center, Chonnam national university Hwasun hospital)

  • 400 patients in Asan Medical center and Chonnam national university Hwasun hospital
    (200 patients of Non-small cell lung cancer, 200 benign nodule controls)
  • MFDS (aka KFDA) Product approval completed

2017

MFDS (aka KFDA) Product approval completed (Class III)

2018

  • CE IVDD Conformity declared
  • Patent applied in 5 countries
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