UK-based immunodiagnostics developer Oncimmune, in alliance with Genostics, has initiated a multi-centre clinical trial of its EarlyCDT-Lung test in the People’s Republic of China.
Designed to enable early detection of lung cancer, EarlyCDT-Lung is a blood test that measures the levels of seven autoantibodies to tumour-associated antigens associated with lung cancer.
As these seven autoantibodies are known to be elevated in all types of lung cancer and from the earliest stage, the test is expected to be able to identify all types of the cancer at all stages (I-IV).
The test runs on a simple enzyme-linked immunosorbent assay (ELISA) platform. Oncimmune noted that EarlyCDT-Lung could detect the cancer nearly four years or more before clinical diagnosis using standard care pathways.
Oncimmune CEO Adam Hill said: “This study is part of our ongoing programme to support the introduction of EarlyCDT-Lung in China, which is progressing to schedule.
“We welcome this initiative and the commitment of our partner Genostics in supporting the introduction of EarlyCDT-Lung into what is one of the world’s largest markets.”
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The multi-centre, case-control trial will involve an extended panel of autoantibodies in order to include variations in the biomarkers expressed on cancer cells in Asian populations.
It will be conducted for around 1,000 early lung cancers at five academic health centres in China. Professor Bai from the Pulmonary Medicine department at Zhongshan Hospital, Fudan University, will lead the study.
Results from the study are expected to be available in the fourth quarter of this year. The company anticipates that the study data will support its application for EarlyCDT-Lung approval in China.
EarlyCDT-Lung is also being studied by the National Health Service (NHS) in a randomised trial for the early detection of lung cancer using biomarkers.