On October 15, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported it has filed an IVD pre-submission with the US Food and Drug Administration (FDA) for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test (Press release, Anixa Biosciences, OCT 15, 2018, View Source [SID1234530496]). The FDA’s Pre-Submission Program (Pre-Sub) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA. In the submission, Anixa requested a face-to-face meeting with the FDA to discuss the agency’s feedback on the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory path.
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Dr. Amit Kumar, CEO of Anixa stated, "We are pleased to request a Pre-Sub meeting with the FDA. This meeting will be an important step in the commercialization path for Cchek as a prostate cancer test, which will be the first in a series of cancer detection and confirmation tests using our Cchek technology." Dr. Kumar continued, "This is a major milestone event for us as we begin the process of interfacing with the FDA on our diagnostic testing technology."
Dr. Kumar added, "This request for a meeting is in addition to a meeting already scheduled with the FDA regarding our CAR-T ovarian cancer therapy. I want to make clear that these are two separate and independent paths that address two different potential products. We are excited to have both of our programs ready for discussions with the FDA, and we plan on sharing the results of those meetings as appropriate."