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Diagnostic Kit for Methylated Genes of Lung Cancer
Diagnostic Kit for Methylated Genes of Lung Cancer

Diagnostic Kit for Methylated Genes of Lung Cancer

Recommended for use in adults with an elevated risk for cancer, 40+ or older

Auxiliary Diagnosis

Early Diagnosis

Differential diagnosis of benign and malignant pulmonary nodule

 

Expanded Use

Follow-up and monitoring

Prognostic evaluation

Therapeutic Assessment


Diagnostic Kit for Methylated Genes of Lung Cancer Description

A blood-based test for diagnosis of lung cancer by detecting a combination of proprietary epigenomics DNA methylation biomarkers.

Sensitivity: 87.24%;

Specificity:97.12%;




diagnostic-kit-for-methylated-genes-of-lung-cancer.png


LDCT



PET-CT


Flexible Bronchoscopy


Sputum Cytology



Chest X-ray


Sensitivity


93.8%[1]  


97%[3]  

Central,88%(67–97%) Peripheral, 78%(36–88%)[4]  


66%[4]  


54%-84%[5]

Specificity

73.4%[1]  

85%[3]  

/  

99%[4]  

90%-99%[5]




limitations

False positive rate: 96.4% Overdiagnosis: ~18.5% Radiation exposure: 1.5mSv ,radiation exposure from LDCT has been estimated to cause one cancer death for every 2,500 screened subject over 20 years [2]  

Radiation exposure:14 mSv False positive result : 18F-FDG is not a cancer specific tracer. Inflammatory cells or granuloma tissue can also take up 18F-FDG.  

Puncture point error Serious complications(0.08%-0.3%) Diagnosis accuracy may decrease with few tissue samples.  

False negative rate: 15%-25% False positive rate: 0.5%-2.5%, some abnormal cells could be sometimes mistaken for malignant cells  

False negative rate  The misdiagnosis rates of peripheral and central lesions were 12% and 8% respectively 6]  


Recommended Population for Screening

  • Smoking history (include current or former smokers) or smoking exposure (second hand smoke).

  • Male and female aged 40 and above.

  • Been diagnosed with pulmonary nodule.

  • Been diagnosed with other lung disease, like chronic obstructive pulmonary diasease (COPD), pulmonary fibrosis, etc.

  • Family history of lung cancer in first degree relatives.

  • Occupational exposures (Agents that are identified specially as carcinogens targeting the lungs).


Studies for Diagnostic Kit for Methylated Genes of Lung Cancer

Proof of concept

Our clinical study program

We actively explore the optimization model and its clinical application in early cancer detection, and cooperate with leading community and academic medical centers around the world.


Real World Comparison

Studies for Diagnostic Kit for Methylated Genes of Lung Cancer

The combination use of ctDNA methylation detection and CT imaging can be used in the differential assistant diagnosis of benign and malignant pulmonary nodules.  

Training cohort: 110 patients with lung nodules Verification cohort: 100 patients with lung nodules  The model of methylation combined with imaging: AUC=0.951  

The model of monomethylation marker alone: AUC=0.912  

The model of Mayo clinic: AUC = 0.823  


Optimization

Studies for Diagnostic Kit for Methylated Genes of Lung Cancer

Diagnosis of colorectal cancer and polyps by CEA, CA19-9, FIT, overall score (P) and combination analysis

Independent variable

Sensitivity

Specificity

PPV

NPV

AUC (95% CI)

Colorectal cancer vs polyps

CEA

0.51

0.754

0.624

0.658

0.731 (0.664–0.798)

CA19-9

0.164

0.946

0.708

0.586

0.683 (0.614–0.753)

FIT

0.664

0.846

0.775

0.759

0.781 (0.718–0.844)

Septin9

0.837

0.946

0.926

0.879

0.901 (0.854–0.947)

SDC2

0.769

0.908

0.87

0.831

0.855 (0.801–0.908)

BCAT1

0.837

0.939

0.916

0.878

0.908 (0.864–0.952)

Overall score (P)

0.827

0.969

0.956

0.875

0.914 (0.871–0.957)

CEA + CA19-9

0.664

0.7

0.639

0.722

0.743 (0.679–0.807)

Overall score (P) + CEA

0.817

0.962

0.944

0.868

0.944 (0.915–0.972)

Overall score (P) + CEA + CA19-9

0.789

0.962

0.943

0.85

0.930 (0.895–0.965)

Overall score (P) + FIT

0.837

0.969

0.956

0.881

0.952 (0.923–0.980)

Overall score (P) + CEA + FIT

0.846

0.954

0.936

0.886

0.962 (0.941–0.983)

Overall score (P) + CEA + CA19-9 + FIT

0.817

0.946

0.924

0.866

0.953 (0.928–0.978)


Methylation overall score (P) + CEA  + FIT, sensitivity 84.6%, specificity 95.4%, positive predictive value 93.6%, negative predictive value 88.6%.  

CRC: 104 vs polyps: 130 vs health: 60  



 

[1] Shlomi D , Ben-Avi R , Balmor G R , et al. Screening for lung cancer: time for large-scale screening by chest computed tomography[J]. European Respiratory Journal, 2014, 44(1):217-238.

[2] Richard M. Hoffman, MD . Lung Cancer Screening[J]. Surgical Clinics of North America,  2017 7;101(4):769-785.

[3] Roberto Luigi Cazzato, Julien Garnon, Behnam Shaygi. PET/CT-guided interventions: Indications, advantages, disadvantages and the state of the art[J]. Minim Invasive Ther Allied Technol. 2018 2;27(1):27-32.

 [4] M, Patricia, Rivera, et al. Establishing the Diagnosis of Lung Cancer: Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines[J]. Chest, 2013.

[5] Gavelli G , Giampalma E . Sensitivity and Specificity of Chest X-Ray Screening for Lung Cancer[J]. Cancer, 2000, 89(11 Suppl):2453-2456.  


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