AnPac Bio-Medical Science Co., Ltd. announced that on December 30, 2021, the Company's Class III medical device for lung cancer auxiliary diagnosis has completed and passed stringent and rigorous registration tests at the testing laboratory designated by the National Medical Products Administration (NMPA), China's regulatory agent for medical products. China's extensive Class III medical device registration tests included medical device performance tests related to accuracy, precision, stability, linearity, accuracy and repeatability in sample addition, cross-contamination, electromagnetic compatibility (EMC), and reliability and performance under various environmental conditions. Completion of the NMPA registration tests is a significant milestone toward obtaining a Class III medical device registration certificate.

Following completion of the registration test, the remaining major step prior to final approval of a registration certificate will be clinical trials which will begin in the first quarter of 2022 with two qualified clinical trial medical institutions. The above-mentioned Class III medical device designation is based on AnPac Bio's novel cancer differentiation analysis (CDA) technology, which has been used in cancer risk assessment tests for general population and clinical studies and has already accumulated more than 240,000 samples including general population screening, as well as extensive retrospective and prospective clinical studies with leading medical institutions. If AnPac Bio is successful in obtaining the Class III registration certificate from the NMPA for its CDA device, it will add additional markets and channels for the Company to sell its tests.

AnPac Bio will be able to penetrate the medical segment of the market, including hospitals and medical institutions for lung cancer auxiliary diagnosis tests, which is a significant market, and can further fuel the Company's revenue growth.