AnPac Bio-Medical Science co. Ltd. (NASDAQ: ANPC) has announced that its Class III lung cancer auxiliary diagnosis device completed and passed strict and rigorous registration testing on December 30, 2021, at the testing lab designated by China’s National Medical Products Administration.
AnPac completed Class II registration tests
China’s extensive Class III medical device registration tests included performance tests associated with precision, accuracy, repeatability, and linearity in sample addition, electromagnetic compatibility, cross-contamination, and reliability under different environmental conditions. The NMPA registration exams are an important step toward acquiring a Class III medical device certificate of registration. Clinical trials, which will commence in Q1 2022 with two certified clinical trial medical institutions, will be the final significant stage before the ultimate approval of a registration certificate following the completion of the registration test.
In December 2018, the company started the formal medical device registration procedure by submitting a medical device categorization application to the NMPA. Since then, AnPac Bio has received a designated inspection capability certificate from the designated medical device registration test laboratory, completed substantial medical device enhancement, finished robust internal medical device laboratory tests, undergone comprehensive external third-party validation and testing, and received a determination of product classification from the NMPA.
Project part of plans to commercialize and market CDA test
CEO Chris Yu said, “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 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.”
