ANPC. Us recently announced that the company has submitted a breakthrough medical device identification application to the U.S. Food and Drug Administration (FDA) based on its cancer risk assessment (CDA) technology on February 1, 2022.
Ampaco bio's new CDA technology and equipment rely on detecting and analyzing biophysical signals in blood samples to assess the risk level of more than 20 cancers. Since its development, ampico biology has conducted a large number of retrospective and prospective clinical trials with partners in hospitals and medical institutions, and collected more than 43000 samples. At the same time, more than 200000 samples of the general population were also tested. Among them, CDA technology has been applied to the cancer risk assessment of the general population, so that the patients finally diagnosed in the hospital after CDA testing can receive treatment earlier and help us fight cancer. Submitting the application for recognition of breakthrough medical devices indicates that we believe that CDA technology is an innovative technology with major innovation and high advantages.
In addition to the laboratories in China, the CLIA & cap certified Laboratory of ampico biology in Philadelphia also carried out the development and verification of CDA technology.
Dr. Yu Chang, CEO and chairman of ampico biology, said: "We are very pleased that we have submitted an application to FDA for the identification of CDA equipment as a breakthrough medical device. We firmly believe that CDA technology is a multi cancer detection platform based on biophysical characteristics. It is very novel and provides many unique advantages, including the ability to detect a variety of cancers, its early stage, its ease of use, high sensitivity, specificity and cost-effectiveness. We are very proud that CDA technology has helped us fight cancer and is currently saving human lives (through cancer risk assessment of the general population to help identify high-risk groups in advance). "
