AnPac Bio-Medical Science (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, has filed with China’s National Medical Products Administration (“NMPA”) for registration testing of its class III, multicancer detection medical device; the device, which has been tested and evaluated extensively, features AnPac’s proprietary Cancer Differentiation Analysis Technology (“CDA”). The company has reported that all preclinical trials and tests conducted through July 2021 have produced positive results. Approval of the NMPA application would allow the device to be used to assist in the diagnosis of 11 different types of cancer, including lung, esophageal, gastric, rectal, colon, liver, breast, cervical, thyroid, pancreatic and brain cancers. The filing also includes a number of cancer types that do not yet have generally accepted biomarkers. The company anticipates that after registration testing of the CDA device, clinical trials at multiple hospitals will start in 2022. “We are extremely pleased with our current achievements and this significant progress in the commercialization efforts of our multicancer CDA technology,” said AnPac Bio CEO and chair Dr. Chris Yu. “Successful completion of this preclinical study for our CDA device and reaching the registration testing stage is a major milestone. This multicancer 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.”
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About AnPac Bio-Medical Science Co. Ltd.
AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 142 issued patents as of March 31, 2021. With two certified clinical laboratories in China and one CLIA-registered clinical laboratory in the United States, AnPac Bio performs a suite of cancer screening and detection tests, including Cancer Differentiation Analysis (“CDA”), biochemical, 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 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 more than 20 different cancer types with high sensitivity and specificity. For more information about the company, visit www.AnPacBio.com
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