AnPac Bio Class III Medical Device Passes Extensive NMPA Registration Tests and Will Start Clinical
Trial in Q1, 2022
Philadelphia, PA, January 4, 2022 – AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer screening and detection, announced today 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.
AnPac Bio began its official medical device registration 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, carried out significant medical device optimization, completed rigorous internal medical device testing, undergone extensive external third-party testing and validation, and received a certificate of designated inspection capability from the designated medical device registration test laboratory.
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.
Dr. Chris Yu, CEO and Chairman of AnPac Bio commented: “We are very excited about this significant milestone and major accomplishment. By passing this challenging and rigorous medical device registration test, we have demonstrated our technical and commercialization capabilities. Lung cancer is a major cancer and there are very few approved registration certificates for lung cancer, so obtaining a Class III medical device registration certificate for lung cancer auxiliary diagnosis would enhance our competitive position in the marketplace and position us for increased revenues. This is one of AnPac Bio’s most important projects, along with our plan to commercialize and market our CDA test as a laboratory developed test (LDT) in the United States. We now expect significant further progress in obtaining Class III medical device registration certificate in China and LDT in the US in 2022.”
About AnPac Bio
AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 150 issued patents as of September 30, 2021. 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 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 43,980 clinical samples as of September 30, 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.
For investor and media inquiries, please contact:
Phil Case, Marketing and Investor Relations
Phone: +1-267-810-6776 (US)
Email: [email protected]
Ascent Investor Relations LLC
Tina Xiao, President
Phone: +1-917-609-0333 (US)
Email: [email protected]
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