LUNGCARE

Clinical Validation for Lung Cancer Screening by ctDNA The SPOT-MAS LUNG Clinical Validation Study

Information

This research aims to:
To evaluate the diagnostic performance of the SPOT-MAS LUNG (SML) ctDNA-based assay for lung cancer detection in low-to-intermediate and high-risk screening populations by estimating its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC).

Gene Solutions Indonesia

Type of Study

Stakeholders Involved

Clinical Validation Study Lung Cancer

Background

Circulating tumor DNA (ctDNA)-based tests offer a promising alternative for cancer detection. A multimodal cfDNA assay named SPOT-MAS LUNG (SML) demonstrated excellent performance, achieving an area under the curve (AUC) of 0.97, with a sensitivity of 90% and a specificity of 92%. LUNGCARE study is initiated to prospectively validate its performance in both low-and-intermediate risk and high-risk screening populations.