Anixa Biosciences has filed an IVD pre-submission with the FDA for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test.

Anixa Biosciences formerly ITUS Corporation , a biotechnology company focusing on cancer diagnostics for all cancers and CAR-T cell immunotherapy for ovarian cancer, could have a profound impact on the cancer diagnostics industry. Anixa's approach includes analyzing immune system cells, combining a patented flow cytometry with an artificial intelligence screening network and database. It transforms cancer screening into a simple blood draw, one that is more accurate and applicable to many more cancers than many existing tests.

Anixa Biosciences announced it has filed an IVD pre-submission with the FDA for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test. 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.

The company has presented a poster that discusses prostate cancer detection - its first commercial focus. The data discuss Cchek's ability to distinguish between tumor bearing and healthy individuals as well as between tumor bearing and those with benign prostate conditions, such as benign prostatic hyperplasia (BPH). It is well known that the majority of men (upwards of 85-90%) who get prostate biopsies do not have cancer. The current screening technique, which measures circulating levels of prostate specific antigen (PSA), causes many men to undergo unnecessary biopsies due to its poor accuracy. Its recent Cchek data demonstrates that many of these unneeded biopsies may be avoided.