China’s National Medical Products Administration recently approved a novel blood-based diagnostic kit for early lung cancer detection.
Developed by researchers at the Hangzhou Institute of Medicine (HIM) under the Chinese Academy of Sciences (CAS), this relatively non-invasive test requires just 2 millilitres of blood and delivers results with over 65 per cent sensitivity for early-stage lung cancer and more than 85 per cent accuracy for distinguishing small pulmonary (potentially malignant) nodules.
The kit checks for special proteins called tumour autoantibodies that are essentially signs your immune system makes when it first notices cancer cells. This test looks for 13 of these proteins at the same time, eight of which have been newly discovered by the research team using modern lab techniques and AI.
It costs about 1,000 yuan or US$100 and has a 1-year shelf life. The screening kit complements CT imaging by helping to boost screening uptake among high-risk groups.
The kit has been crafted to help address the Chinese lung cancer crisis, largely attributable to late diagnoses. Its key advantage is being able to help differentiate benign from malignant growths.
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Ten years of research went into kit’s creation
Led by Professor Hu Hai of HIM and Zhejiang Cancer Hospital, the project shifts focus from imaging to molecular blood signals, promising to lower mortality rates through widespread, accessible screening. His research team has been studying tumour autoantibodies for the past decade.
In extensive clinical trials at leading healthcare facilities like Tongji Hospital and Beijing Chest Hospital, the kit was tested on 1,463 patients with suspicious lung nodules. Among the group of 794 who turned out to have lung cancer, 58 per cent or 462 cases were identified at an early-stage.
“Determining whether a pulmonary nodule is benign or malignant is key to solving the challenge of early lung cancer diagnosis and reducing lung cancer mortality,” said Hangzhou lead researcher Hu Hai in an article from Chinese state media.
This demonstrates the test’s advantageous nature because it detected more than 65 per cent of those early-stage cancers through a simple blood draw. This rate of performance is significantly higher than traditional blood biopsies, such as those that rely on circulating tumour DNA, which tend to miss many early-stage cases. It helps doctors to distinguish harmless or benign nodules from ones of concern, thereby potentially leading to improved survival rates.
Institutions have considerable oncology backgrounds
This latest development builds on the HIM’s and CAS’s considerable experience in lung cancer research and the oncology field. Teams from these institutions have completed rigorous studies examining the connection between lung cancer, the body’s immune system and gut bacteria.
Furthermore, they have created small lab models of lung tumours to guide personalized medicine and completed cancer drug trials, among other things.
This blood-based breakthrough joins other non-invasive advances, including Breath Diagnostics’ OneBreath, a breath test that detects volatile organic compounds indicative of early lung cancer with 94 per cent sensitivity from one exhale.
Read more: Breath Diagnostics completes install of advanced mass spectrometry system
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