Anixa Biosciences, Inc., a biotechnology company focused on using the body’s immune system to fight cancer, announced that it has entered into a strategic alliance with ResearchDx to launch its Cchek™ Prostate Cancer Confirmation (Cchek™ PCC) test as a Laboratory Developed Test. ResearchDx is a CLIA certified, CAP Accredited laboratory located in Southern California. Once launched, Cchek™ PCC will be available to patients throughout the United States, with the exception of New York state, which requires additional regulatory certification.
ResearchDx will begin clinical validation of Cchek™ PCC with the goal of launching the test in the third quarter of 2019. The steps necessary to launch the test include running samples to train the neural network (Anixa’s artificial intelligence application for analysis), followed by analytical and clinical validation. Cchek™ PCC is designed to confirm the presence of cancer in a preliminarily diagnosed patient prior to biopsy. ResearchDx will perform the test in its CLIA laboratory according to the Anixa developed protocols and Artificial Intelligence (AI) analysis.
Dr. Amit Kumar, CEO of Anixa Biosciences stated, “We are pleased to commence this non-exclusive partnership with ResearchDx to launch our test as a laboratory developed test. We are looking forward to enabling patients and physicians to utilize this test as a tool to help manage their prostate health.”
“We have evaluated the market opportunity for Anixa’s Cchek™ PCC, and we are excited about launching the test. After reviewing the performance of the test, which combines flow cytometry and artificial intelligence, we feel confident that we can reproduce the results and complete the requisite validations in our hands in our CLIA laboratory,” stated Dr. Mathew Moore, Co-founder and Principal of ResearchDx.