NEW YORK - AnPac Bio-Medical Science, a cancer screening and detection company, said on Monday that it has filed for registration testing of its Class III, multicancer detection device with China's National Medical Products Administration.
The company completed a preclinical trial of the device, which is based on the company's Cancer Differentiation Analysis technology, in July 2021.
"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," said Chris Yu, CEO of AnPac Bio.
AnPac Bio's CDA technology aims to determine a cancer's precise location within the body, the patient's future cancer risk, and where in the body future risk is highest. The CDA technology uses an integrated sensor system to detect several biophysical signals at the cellular, protein, and molecular levels, and a proprietary algorithm synthesizes this data to generate a personalized risk assessment for each patient, according to the company's website.
The new application covers the device's utility in assisting with the diagnosis of 11 types of cancer, including lung, esophageal, gastric, rectal, colon, liver, breast, cervical, thyroid, pancreatic and brain cancers. This expands on the previous device, which focused solely on lung cancer.
Several cancer types covered by the filing lack generally accepted biomarkers, including esophageal, thyroid, and brain cancers, the company noted.
The preclinical study supporting the filing included over 20 retrospective validation studies across over 10 US hospitals. They involved over 43,000 clinical samples covering over 60 cancer types, including two single-blind retrospective preclinical studies in thyroid cancer.
More support came from approximately 18,000 cancer risk assessments performed in the general population using the company's CDA-based tests, with follow-up from over 14,200 individuals through the end of July, and from community-based prospective cancer screening studies.
AnPac Bio expects a clinical trial in the first half of 2022, following completion of registrational tests. The company also intends to file additional medical device registrations in China.
"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," Yu said. "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 in the US."