China’s NMPA Approved Starting of Registration Testing of AnPac Bio Class III Medical Device (For Lung Cancer Auxiliary Diagnosis Utility)
San Jose, CA, February 8, 2021 – AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, announced today that on January 25, 2021, the National Medical Products Administration (the “NMPA”), China’s medical product regulatory authority, has approved for AnPac Bio to start the registration testing of its Class III lung cancer auxiliary diagnosis medical device at a designated medical device testing laboratory, which is a significant step towards obtaining a Class III medical device registration certificate by AnPac Bio. AnPac Bio began its medical device registration application process in December 2018, by filing an application for medical device classification with the NMPA. Since then, AnPac Bio has obtained the determination of the product classification (recommended as Class III) from the NMPA, and carried out medical device optimization, internal medical device testing and external third party testing and validation, and obtained the certificate of designated inspection capability from the designated medical device registration testing laboratory. Once the medical device passes the product registration testing, the next major step will be a clinical trial. AnPac Bio plans to conduct the clinical trial in at least two qualified clinical trial medical institutions, each of which is expected to enroll at least 300 subjects (covering the control group and the confirmed lung cancer group).
The above-mentioned Class III medical device is based on AnPac Bio’s novel cancer differentiation analysis (CDA) technology and has been used in cancer risk assessment tests of over 200,000 samples including general population screening, as well as 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, AnPac Bio will also be able to penetrate the Chinese hospital market as well as other medical institutions for lung cancer auxiliary diagnosis tests, which will expect to further fuel the Company’s growth in revenue.
Dr. Chris Yu, CEO and Chairman of AnPac Bio commented: “We are very pleased about this significant progress in our registration application for our Class III lung cancer auxiliary diagnosis medical device. This application is one of the most important projects of AnPac Bio’s, along with our plan to market our CDA test as a laboratory developed test (LDT) through our US labs. A lot of resources and hard work have been devoted to this project. We will continue to diligently move forward the project.”
About AnPac Bio
AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 128 issued patents as of June 30, 2020. With two certified clinical laboratories in China and one CLIA and CAP accredited clinical laboratory in the United States, AnPac Bio performs a suite of cancer screening and detection tests, including CDA (Cancer Differentiation Analysis), bio-chemical, immunological, and genomics tests. According to Frost & Sullivan, AnPac Bio ranked third worldwide and first in China among companies offering next-generation early cancer screening and detection technologies in terms of the number of clinical samples for cancer screening and detection, based on approximately 41,700 clinical samples as of December 31, 2019. 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.