By Chris Wack
AnPac Bio-Medical Science Co. Ltd. said it filed with China's National Medical Products Administration last week for registration testing of its class III, multicancer detection medical device based on its cancer differentiation analysis technology.
The company said this multicancer detection medical device has been extensively evaluated and positive results have been obtained from successful preclinical trials completed through July 2021.
The application with the NMPA covers the utility of assisting in diagnosis of 11 types of cancer: lung, esophageal, gastric, rectal, colon, liver, breast, cervical, thyroid, pancreatic and brain cancers.
The current filing for AnPac Bio's device includes a number of cancer types which don't yet have generally accepted biomarkers, including esophageal, thyroid and brain tumors. Following registration testing of the device, it is expected that clinical trials at multiple hospitals will start in 2022.
In February, AnPac Bio entered into the registration testing phase for its CDA device, a class III medical device for assisting in diagnosis for lung cancer. The device is now waiting in line at an NMPA designated testing lab for registration tests, with a clinical trial expected in the first half of 2022 after its registration tests are completed. AnPac Bio plans to file additional medical device registrations in China and also intends to pursue and offer multi-cancer detection as laboratory developed tests in the U.S. through its certified U.S. lab.
AnPac Bio shares were up 11% to $3.75 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
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August 23, 2021 at 07:08PM
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