PulmoSeek, a cell-free DNA-methylation-based non-invasive early lung cancer screening product developed by AnchorDx, was approved by EMA, so the company can place a CE (Conformité Européenne) mark on their product.
Founded in 2015, AnchorDx applies high-throughput DNA methylation to develop NGS (next-generation sequencing) early cancer screening and diagnosis products. Their product pipelines cover lung, colorectal, breast, and bladder cancer. Some of them have already been approved by FDA and EMA (European Medicines Agency).
According to the GLOBOCAN 2020, the cancer data released by the International Agency for Research on Cancer (IARC), lung cancer has more than 2.2 million new cases and about 1.8 million deaths worldwide every year, which accounts for 18% of the total cancer deaths. The prognosis of lung cancer was highly correlated with the diagnostic timing. The 5-year overall survival rate decreased significantly from 85% in Stage IA to 6% in Stage IV. Early screening and diagnosis of lung cancer can save medical costs and retain life to the greatest extent.
LDCT (low-dose computed tomography) is recommended in the clinical guidelines for lung cancer screening, but the problem is its poor image accuracy. For small ground glass lung nodules, there are some obstacles to observing subtle features such as fine burrs and vacuoles, and it is necessary to re-examine the thin-layer mean volume dose CT. PulmoSeek™ Lung Cancer Early Detection Assay applies to the benign and malignant diagnosis of 5-30mm pulmonary nodules, which can accurately manage the pulmonary nodule population after LDCT screening.
At present, pan-cancer screening companies include Burning Rock (Chines: 燃石医学), Grail, and Exact Sciences. Single cancer screening includes Berry Genomics (Chinese: 贝瑞基因), Genetron Health (Chinese: 泛生子), and New Horizon Health (Chinese: 诺惠健康).