Breath Cancer Screening Device BreatheLens Receives CE Certification: Detecting 6 Early Cancers Through Exhaled Air

Israeli medical technology company BreathDx today announced that its breath cancer screening device BreatheLens has received EU CE certification as a Class IIb medical device. BreatheLens detects 6 common cancers at Stage I by analyzing volatile organic compound (VOC) biomarker combinations in patients exhaled breath: lung, gastric, colorectal, pancreatic, liver, and esophageal cancer.

Technical Principle

Human exhaled breath contains over 3,000 types of VOCs. When cancer cells are present, their abnormal metabolism produces specific VOC combination patterns resembling a unique metabolic fingerprint. BreatheLens core technology precisely identifies these cancer-related metabolic fingerprints from complex VOC backgrounds.

BreatheLens uses BreathDxs proprietary nanowire sensor array with 32 differently coated nanowire sensors, each selectively responsive to specific VOC molecules. After a patient blows into the device for 3 seconds, the sensor arrays response pattern is analyzed by a deep learning model outputting positive probability scores for each of the 6 cancers.

Co-founder and CSO Dr. Noah Aviv said BreatheLens core advantage lies in training data scale, with over 120,000 subjects breath samples collected from 23 hospitals globally, including approximately 8,000 cancer patients, constituting the worlds largest breathomics dataset.

Performance Data

In a prospective clinical trial involving 15,000 subjects, BreatheLens achieved 87% overall sensitivity and 91% specificity. Lung cancer sensitivity was highest at 93%, while pancreatic cancer was lowest at 79%. Compared to traditional blood tumor markers, BreatheLens averaged 22 percentage points higher sensitivity across all 6 cancers. Single-test pricing is estimated at 50-80 euros, with European commercial deployment beginning Q3 2030 and FDA 510(k) submission under review.