NMPA approves immunoassay kit for early diagnosis of 13 types of lung cancer

https://www.cas.cn/cm/202601/t20260126_5097284.shtml

The CAS Hangzhou Institute of Medical Sciences has developd a kit for detecting thirteen types of lung cancer-related antibodies using flow cytometry immunoassay). The kit has obtained a Class III medical device registration certificate from the National Medical Products Administration (NMPA).

Low-dose spiral CT is a commonly used screening method for lung cancer, but it is difficult to distinguish between benign and malignant small lung nodules. Using a million-level cancer tissue library and multimodal high-throughput screening technology, combined with synthetic biology methods to express over 400 key proteins for early-stage lung cancer, the Hangzhou team developed liquid suspension chip technology and artificial intelligence algorithms to screen 13 biomarker combinations with optimal diagnostic performance. Eight of these are novel biomarker combinations.

The reagent kit has been tested in several hospitals with 1463 patients with pulmonary nodules, of whom 794 had lung cancer, with early-stage lung cancer accounting for 58.19%. Data shows that its sensitivity for early-stage lung cancer detection exceeds 65%, and its accuracy is superior to traditional tumor markers.

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