AnPac Bio-Medical Science (NASDAQ: ANPC), a biotechnology company focused on early cancer screening and detection with operations in the United States and China, has filed for a breakthrough device designation request for its cancer differentiation analysis (“CDA”) technology-based medical device; the company filed the request with the Food and Drug Administration (“FDA”) earlier this week. According to the announcement, the company’s novel CDA technology and medical device detects and analyzes biophysical signals in a blood sample to determine the risk level of more than 20 different types of cancers. AnPac Bio has collected more than 43,000 samples as the company has worked with hospitals and medical institutions in extensive retrospective and prospective clinical trials. In addition, the company has screened another 200,000 samples from the general population. “We are very pleased with the FDA filing of the CDA medical device for a breakthrough medical device designation,” said AnPac Bio CEO and chair Dr. Chris Yu in the press release. “We strongly believe that our CDA technology, a multicancer detection platform based on the measurement of biophysical properties, is highly novel and offers many unique advantages, including the ability to detect multiple cancer types early, as well as its ease of use, high sensitivity and specificity, and cost effectiveness. We are very proud that CDA technology is already helping us in our fight against cancer and is currently saving human lives.”
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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 150 issued patents as of Sept. 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 Cancer Differentiation Analysis (“CDA”), biochemical, immunological and genomics tests. According to a report by Frost & Sullivan, AnPac Bio ranked first globally in multicancer screening and detection test sample volume (accumulative to January 2021). AnPac Bio’s CDA technology platform has been shown in retrospective validation studies 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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