AnPac Bio-Medical Science (NASDAQ: ANPC), a U.S.- and China-based biotechnology company focused on early cancer screening and detection, announced that its Class III medical device for lung cancer auxiliary diagnosis has passed stringent and rigorous registration tests; the tests were conducted at a testing laboratory selected by China’s regulatory agent for medical products, the National Medical Products Administration (“NMPA”). The device passed tests designed to measure accuracy, precision, stability, linearity, accuracy and repeatability in sample addition, cross-contamination, electromagnetic compatibility (“EMC”), and reliability and performance under various environmental conditions. According to AnPac Bio, completion of the tests is an important achievement in the process of obtaining a Class III medical device registration certificate. The company noted that one major step remains before obtaining final approval of a registration certificate — clinical trials testing the device are scheduled to begin at two qualified medical institutions in Q1 2022. “We are very excited about this significant milestone and major accomplishment,” said AnPac Bio CEO and chair Dr. Chris Yu in the press release. “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 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.”
To view the full press release, visit https://ibn.fm/0kyWK
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 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, based on approximately 43,980 clinical samples as of Sept. 30, 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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