Creative Biosciences

Lunsafe _®

Noninvasive Early Detection with Lunsafe _®

Lunsafe® was approved by NMPA (National Medical Products Administration) on May 29, 2025, making it the very first sputum-based methylation detection kit for lung cancer in China. It detects early-stage lung cancer by analyzing genetic abnormalities in exfoliated tumor cells found in sputum, specifically focusing on methylation of the human HOXB4 and SRCIN1 genes. This non-invasive method helps identify early pathological changes in patients, offering the potential to intercept lung cancer at an early stage—ultimately contributing to its prevention and possible cure.

Lunsafe_®

Pioneer sputum-based methylation kit for early detection of lung cancer

Early detection

Accurate

Noninvasive

Convenient

Product Performance

Clinical trial shows Lunsafe’s sensitivity to stage I-II lung cancer at 82.82%, specificity 91.79%

82.82%

Sensitivity

91.79%

Specificity

Participating clinics for clinical trial： Nanfang Hospital of Southern Medical University / Peking University People's Hospital / Zhujiang Hospital of Southern Medical University / The First Affiliated Hospital of Nanchang University / Meizhou People's Hospital / Jiangmen Central Hospital / Zhanjiang Central People's Hospital / Gaozhou People's Hospital

Effective Differentiation Between Benign and Malignant Lung Nodules

Clinical trial study results show that, when compared with clinical diagnosis, Lunsafe@ has a positive agreement rate of 78.35% for malignant pulmonary nodules (Stage 1-ll), 86.82% for Stage ll-V lung cancer; a negative agreement rate of 90.38% for benign pulmonary nodules, and 93.04% for inflammatory pulmonary nodules.

Individuals with high-risk of lung cancer

Individuals aged 45 years and older

Individuals with a history of smoking,
secondhand smoking, or prolonged
exposure to cooking oil fumes

Individuals with
occupational exposure to
known carcinogens

Family history of lung
cancer in first-degree and
second-degree relatives

Individuals with a
history of chronic pulmonary
diseases

Noninvasive Early Detection with Lunsafe ®

Lunsafe®

Product Performance

Individuals with high-risk of lung cancer

Noninvasive Early Detection with Lunsafe _®

Lunsafe_®