PulmoSeekTM Lung Cancer Early Detection Assay, the non-invasive blood-based cfDNA methylation detection product developed by AnchorDx for the early diagnosis of lung cancer, recently completed the procedure for EU IVDD CE Marking and obtained IVD reagents licensing signed and issued by the CIBG of Ministry of Health, Welfare and Sport in the Netherlands. The license number is NL-CA002-2022-71591.
PulmoSeekTM is applicable for the benign and malignant diagnosis of people with 5-30mm pulmonary nodules. In the earlier stage of prospective clinical studies at 14 centers, the product’s excellent performance was well verified in the following:
- 6-20mm size nodules subgroup, with a sensitivity of 100.0%;
- Stage I lung cancer subgroup, with a sensitivity of 97.1%;
- Solid nodules, part-solid nodules, and ground-glass nodules, with a sensitivity of 100.0%, 94.7% and 96.4%, respectively;
In head-to-head comparison, PulmoSeekTM outperformed PET-CT, Mayo Model and Veterans Affairs Model, and will provide an innovative non-invasive detection solution for the precise management of patients with pulmonary nodules. Relevant results have been published in the renowned international medical journal, The Journal of Clinical Investigation (impact factor: 14.808) in 2021.
According to GLOBOCAN 2020 data released by the International Agency for Research on Cancer (IARC), lung cancer is the leading cause of cancer deaths (18%) with more than 2.2 million new cases and 1.8 million deaths annually worldwide. As a screening technology for lung cancer, LDCT has been widely recognized by domestic and international clinical guidelines, but the precise management of patients with pulmonary nodules after LDCT screening has also become an urgent clinical problem to be solved.
PulmoSeekTM Lung Cancer Early Detection Assay can achieve early diagnosis and treatment of lung cancer through accurate diagnosis of patients with benign and malignant pulmonary nodules. Currently, several of AnchorDx’s products have obtained relevant IVD-related qualifications from US FDA and European Medicines Agency (EMA). PulmoSeek’s access permit for the EU market will further promote this innovative precision medical product to benefit more patients with pulmonary nodules around the world forthwith.