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AnPac Bio-Medical Science Co. Ltd. (NASDAQ: ANPC) Files for National Medical Products Administration Registration of Early-Warning Cancer Technology with a Record 11 Tumor Types Under Formal Medical Device Product Registration
September 13, 2021

AnPac Bio-Medical Science Co. Ltd. (NASDAQ: ANPC) Files for National Medical Products Administration Registration of Early-Warning Cancer Technology with a Record 11 Tumor Types Under Formal Medical Device Product Registration

  • AnPac Bio-Medical Science Co., Ltd. has developed its proprietary Cancer Differentiation Analysis (“CDA”) technology to detect biophysical signals as an alternative early disease indicator to blood-based biomarker testing for cancer
  • The company has laboratories and R&D facilities in China equipped for CDA testing and cancer biochemical testing, as well as a CLIA/CAP accredited laboratory in the United States 
  • AnPac Bio recently held its 2021 technical symposium in China where KOLs from major hospitals and universities discussed new technologies for cancer detection and treatment.

AnPac Bio-Medical Science (NASDAQ: ANPC) is moving forward with testing and registration of its multi-cancer screening technology in its drive toward commercialization of its proprietary CDA device for a variety of conditions, with the filing of a record 11 types of cancers for assisting in diagnosis in a formal medical device product registration testing application with NMPA. 

AnPac Bio’s pioneering CDA technology has already produced annual revenues from cancer risk assessment tests for multiple cancers in general population. In 2020, significant growth was achieved with revenues of $3.2 million, according to a Prospectus Supplement filed with the U.S. Securities and Exchange Commission last month (https://ibn.fm/Me4Tk). The current filing announced August 23rd, with China’s National Medical Products Administration (“NMPA”) seeks to expand the usage of CDA technology-based cancer risk testing into hospitals. 

The 11 cancers which are tumors of the lung, esophagus, stomach, rectum, colon, liver, breast, cervix, thyroid, pancreas and brain, includes  three types of tumors (esophageal cancer, thyroid cancer and brain tumor) that do not yet have generally accepted blood-based biomarkers to be detected with simple blood tests, according to a recent news release about Anpac Bio’s NMPA filing (https://ibn.fm/ot65X).

AnPac Bio’s early-detection CDA technology utilizes a biophysical approach which includes acoustical, electrical, magnetic, nano-mechanical and optical environment properties in the blood to determine the risk of more than two dozen cancers. 

The CDA technology and the company’s proprietary algorithm “measure and analyze these signals at multiple biological levels (including the protein, cellular and molecular levels) and with multiple parameters” that include Protein Tumor Factor and Cellular Tumor Factor data as well as an “overall CDA value,” according to last month’s SEC filing. 

AnPac Bio’s NMPA filing this month builds on extensive evaluation and successful preclinical trials completed through July, 2021, with the aim of beginning clinical trials at multiple hospitals next year following completion of registration testing with the NMPA. 

On Aug. 6, AnPac Bio held its 2021 technical symposium in Shanghai with representatives from global fortune 500 companies, life science companies, major hospitals and leading medical schools in attendance, as well as investors and shareholders. The symposium focused on cutting-edge theories, technologies and methods relating to cancer treatment and prevention. 

The presentations included hospitals’ evaluations of the CDA technology in clinical trials carried out earlier this year, as well as newly un-blinded and analyzed clinical trial data. Fudan University-affiliated Shanghai Tumor hospital, Changhai Hospital and Jiaotong University School of Medicine reported that CDA technology performed well in distinguishing between the healthy and cancer patient groups. They concluded that the CDA technology, its simplicity, high sensitivity and specificity, is an excellent technology for detecting a variety of cancers early, and in particular for early detection of lung and thyroid cancers.

For more information, visit the company’s website at www.AnPacBio.com.

NOTE TO INVESTORS: The latest news and updates relating to ANPC are available in the company’s newsroom at https://ibn.fm/ANPC 

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