Benzinga | Aug 23, 2021 07:32AM EDT

AnPac Bio Successfully Completes Major PreClinical Study, Files with National Medical Products Administration for Registration Testing of Its Multi-Cancer CDA Device

AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ:ANPC), a biotechnology company with operations in the United States and China, today announces that the Company filed with China's National Medical Products Administration (NMPA) on Aug. 19, 2021, for registration testing of its class III, multi-cancer detection medical device based on its Cancer Differentiation Analysis Technology (CDA).

This multi-cancer detection medical device has been extensively evaluated and positive results have been obtained from successful preclinical trials completed through July 2021. The application with the NMPA covers the utility of assisting in diagnosis of 11 different types of cancer, including lung, esophageal, gastric, rectal, colon, liver, breast, cervical, thyroid, pancreatic and brain cancers. The current filing for AnPac Bio's multi-cancer CDA device includes a number of cancer types which do not yet have generally accepted biomarkers, including esophageal, thyroid and brain tumors. Following registration testing of the multi-cancer CDA device, it is expected that clinical trials at multiple hospitals will start in 2022.

The current filing significantly expands the number of cancer types to be detected over the previously filed CDA device that was solely for lung cancer detection. The Company's preclinical study included (a) over 20 retrospective validation studies at over 10 hospitals across the country involving over 43,900 clinical samples covering more than 60 types of cancer, out of which two single blind retrospective preclinical studies were completed in Q2 2021 on thyroid cancer screening and lung cancer screening, respectively, (b) extensive general population cancer risk assessment tests of approximately 180,000 tests by the end of July 2021, undertaken with the Company's commercial CDA-based tests, and follow-up studies on over 14,200 individuals by the end of July, and (c) community-based prospective cancer screening investigations.

As announced on Feb. 8, 2021, AnPac Bio entered into the registration testing phase for its CDA device, a class III medical device for assisting in diagnosis for lung cancer. The device is now waiting in line at an NMPA designated testing lab for registration tests, with a clinical trial expected in the first half of 2022 after its registration tests are completed. AnPac Bio plans to file additional medical device registrations in China and also intends to pursue and offer multi-cancer detection as Laboratory Developed Tests (LDTs) in the U.S. through its certified U.S. lab.

Dr. Chris Yu, CEO and Chairman of AnPac Bio, commented: "We are extremely pleased with our current achievements and this significant progress in the commercialization efforts of our multi-cancer CDA technology. Successful completion of this preclinical study for our CDA device and reaching the registration testing stage is a major milestone. This multi-cancer detection medical device is an important product of our company that we believe has significant advantages over currently marketed technologies. Once this medical device is approved for commercialization by the NMPA, it will also be an important revenue source for AnPac Bio, and we believe that it has considerable market potential. We will continue to accelerate the product registration process for this medical device, as well as work towards marketing our CDA-based tests as Laboratory Developed Tests (LDTs) in the U.S."