AnPac Bio Successfully Completes Major PreClinical Study, Files with National Medical Products Administration (NMPA) for Registration Testing of Its Multi-Cancer CDA Device
PHILADELPHIA, Aug. 23, 2021 – via Investor Wire – 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.”
About AnPac Bio
AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 142 issued patents as of March 31, 2021. With one CLIA registered clinical laboratory in the United States and two certified clinical laboratories in China, AnPac Bio performs a suite of cancer screening and detection tests, including CDA (Cancer Differentiation Analysis), biochemical, immunological and genomics tests. According to a Frost & Sullivan’s report issued in 2020, AnPac Bio ranked third worldwide among companies offering next-generation early cancer screening and detection technologies in terms of the number of clinical samples for cancer screening and detection in 2019. The Company has a significant cancer screening and detection database consisting of approximately 43,900 clinical samples as of March 31, 2021. AnPac Bio’s CDA technology platform has been shown in retrospective validation studies to be able to detect the risk of over 20 different cancer types with high sensitivity and specificity.
For more information, please visit: https://www.Anpacbio.com.
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Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. The Company has attempted to identify forward-looking statements by terminologies including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “target,” “aim,” “predict,” “outlook,” “seek,” “goal” “objective,” “assume,” “contemplate,” “continue,” “positioned,” “forecast,” “likely,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the implementation of our business model and growth strategies; trends and competition in the cancer screening and detection market; our expectations regarding demand for and market acceptance of our cancer screening and detection tests and our ability to expand our customer base; our ability to obtain and maintain intellectual property protections for our CDA technology and our continued research and development to keep pace with technology developments; our ability to obtain and maintain regulatory approvals from the NMPA, the FDA and the relevant U.S. states and have our laboratories certified or accredited by authorities including the CLIA; our future business development, financial condition and results of operations and our ability to obtain financing cost-effectively; potential changes of government regulations; general economic and business conditions in China and elsewhere; our ability to hire and maintain key personnel; our relationship with our major business partners and customers; and the duration of the coronavirus outbreaks and their potential adverse impact on the economic conditions and financial markets and our business and financial performance, such as resulting from reduced commercial activities due to quarantines and travel restrictions instituted by China, the U.S. and many other countries around the world to contain the spread of the virus. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.