AptoDetect™ - Lung

Provides quick and easy blood test for early lung cancer
diagnosis with small amount of blood

Product introduction

AptoDetect™-Lung is the first lung cancer diagnostic kit (Class III)
registered under Ministry of Food and Drug Safety (MFDS, also known as KFDA).
AptoDetectTM-Lung provides risk information (low or high-risk group) by using its algorithm
and quantification of total 7 proteins – 4 types of cancer growth-related proteins
(EGFR1, MMP7, CA6, and KIT) and 3 types of immune-related proteins (CRP, C9, and SERPINA 3).

Product composition A set · B set
Specimen Blood (serum) 5 uL
Registration status MFDS approval (Class III, 2017), CE DoC (2018)
Specification
  • In-vitro diagnostics for early lung cancer diagnostics with 7 multivariate biomarkers.
  • Provides the test result from its analysis program.
  • Provides lung cancer risk information (high risk/ low risk) in a score form from 0 to 10.
  • Sensitivity 75%, Specificity 92%
Product composition A set · B set
Specimen Blood (serum) 5 uL
Registration status MFDS approval (Class III, 2017), CE DoC (2018)
Specification
  • In-vitro diagnostics for early lung cancer diagnostics with 7 multivariate biomarkers.
  • Provides the test result from its analysis program.
  • Provides lung cancer risk information (high risk/ low risk) in a score form from 0 to 10.
  • Sensitivity 75%, Specificity 92%

Recommended patients

Patients of high risk group

Patients with indeterminate nodules and in need of further examination

Individuals with a family history of cancer or are currently smoking

Patients after surgery in need of follow-up care and regular check-ups to watch for recurrence.

※ High risk group: Patients between 55-74 with at least 20 pack-year history of smoking (equivalent to smoking one pack of cigarette per day for 30 years)

Test Procedure

1

Blood sampling

2

7 types of proteins
in blood-aptamer bound

3

Quantification with
Luminex 200

4

Result calculated
through algorithm

5

Report printed

※ AptoDetect™-Lung test starts from sampling patient’s blood

Test benefits

1

Higher diagnostics performance of multivariate biomarkers confirmed through
comparative clinical trials with single biomarker.

2

Further in-depth examination provided for patients with nodules found
from Low-dose computed tomography

LDCT test simulation on 1,000 patients in high risk group : increase of LDCT accuracy confirmed

Accuracy PPV Example (PPV)
LDCT screening 73% 1 in 25
AptoDetect™-Lung + LDCT 91.4% 1 in 4
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