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PulmoPath™️

Methylation test for auxiliary diagnosis of early lung cancer, improving the overall clinical diagnosis rate

Background of Disease

Lung cancer ranks first in the number of new cases and the number of deaths
  • 828,000 new cases of lung cancer and 657,000 of deaths from lung cancer[1] .
  • The 5-year survival rate is above 90% for the early-stage lung cancers and less than 10% for the late stages.
The accuracy of auxiliary diagnosis for early lung cancer needs to be improved
  • The sensitive of bronchoscopy is not sufficient. The average diagnostic accuracy of bronchoscopy for distal bronchial and extratracheal lesions is only 31% [2-3] .
  • The diagnostic accuracy of percutaneous lung biopsy fluctuates remarkably, showing a high requirement for sampling[4-6] .

Product Advantages

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  • 84.1
    %
    Sensitivity
  • 83.3
    %
    Specificity
  • 84.1
    %
    Accuracy
  • Noninvasive

    The product is suitable for the BALF sample types

  • Professional

    AnchorDx and West China Hospital, Sichuan University, jointly developed and clinically validated

  • Sensitive

                   Sensitivity 84.1%

  • Accurate

    Positive predictive value (PPV) 92.5%

Professional Certification

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  • AnchorDx and West China Hospital, Sichuan University, jointly developed and clinically validated

    The clinical data was published in Clinical Epigenetics (2021, IF=7.259)[7].

Target Users

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    Patients with undiagnosed pulmonary nodules without contraindications to bronchoscopy.

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    Patients with suspected lung cancer requiring bronchoscopy.

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    Patients with negative results from bronchoscopy or percutaneous lung biopsy who are still clinically suspected of having lung cancer.

Sample Collection and Service Process

Sample collection
  • BALF or tissue sample
Service process
  • Test counseling
  • Sample collection
  • Sample transport
  • Testing and Analysis
  • Report issuance
  • After-sales support

References

  • [1] Report of Cancer Epidemiology in China, 2015. Chinese Journal of Oncology, 2019;41(1).
  • [2] Lung Cancer Group, Respiratory Branch of Chinese Medical Association, and Expert Group of China Lung Cancer Alliance. Chinese Expert Consensus on Diagnosis and Treatment of Lung Nodules[J]. 2015.
  • [3] Zhixin Qiu and Weimin Li. Diagnosis and Handling Progress of Lung Nodules[J]. West China Medical Journal, 2018(1):8-14.
  • [4] Tsukada H, Satou T, Iwashima A, Souma T. Diagnostic accuracy of CT-guided automated needle biopsy of lung nodules. AJR Am J Roentgenol. 2000;175(1):239-243.
  • [5] Hongtao Fan, et al. Clinical analysis of 120 cases of CT-guided percutaneous lung biopsy [J]. Journal of Clinical Pulmonary Medicine, 2013, 18(3):568.
  • [6] The Society of Interventional Oncology, CACA and the Expert Committee on Diagnosis and Treatment of Thoracic Tumors, the Society of Interventional Oncology, CACA. Chinese Expert Consensus on Percutaneous Biopsy of Thoracic Tumors (2020) [J]. Chinese Medical Journal, 2021, 101(3): 185-198.
  • [7] Li L, Ye Z, Yang S, et al. Diagnosis of pulmonary nodules by DNA methylation analysis in bronchoalveolar lavage fluids. Clin Epigenetics. 2021;13(1):185.