AnPac Bio Class III Medical Device Passes Extensive NMPA Registration Tests and Will Start Clinical Trial in Q1, 2022
AnPac Bio began its official medical device registration process in
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.
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About AnPac Bio
AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 150 issued patents as of
For more information, please visit: https://www.Anpacbio.com.
For investor and media inquiries, please contact:
Company:
Phone: +1-267-810-6776 (US)
Email: phil_case@AnPacbio.com
Investor Relations:
Ascent Investor Relations LLC
Phone: +1-917-609-0333 (US)
Email: tina.xiao@ascent-ir.com
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 and registration certificates 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
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Source: AnPac Bio-Medical Science Co., Ltd. (ANPC)