SAN JOSE, Calif., June 13, 2018 /PRNewswire/ -- ITUS Corporation (NASDAQ: ITUS) today announced that it has chosen prostate cancer as the first commercial focus for its Cchek™, non-invasive liquid biopsy cancer detection platform.
ITUS has previously reported that its Cchek™ technology, which utilizes immune-profiling using flow cytometry coupled with artificial intelligence, has demonstrated the ability to identify twenty different cancer types through a simple blood test. While testing of additional cancers continues, ITUS has determined that it is now positioned to choose an initial tumor type as its first commercial aim. The decision incorporated a number of factors including, key scientific, clinical, and commercial considerations as follows:
Scientific Considerations: Our recent studies with prostate cancer demonstrate excellent sensitivity and specificity. One highlight is the recent study completed with Memorial Sloan Kettering Cancer Center (MSK) and Serametrix Corporation. This study achieved 92% sensitivity and 92% specificity using 121 prostate cancer and 125 healthy donor samples. The Cchek™ artificial intelligence was trained on 85 late-stage, biopsy verified, prostate cancer samples and 88 healthy donor samples. After training, ITUS was provided an additional 73 unlabeled (blinded) samples, and ITUS correctly identified 33 of 36 prostate cancer samples and 34 of 37 healthy donor samples.
Clinical Considerations: While prostate specific antigen (PSA) testing is the primary method of screening for prostate cancer, it is well known that this test produces large numbers of false results. As a result, most prostate biopsies, successive to high PSA scores, are negative. Therefore, a tremendous opportunity exists to identify many males that do not need expensive, painful and risk-laden biopsy procedures. Eventually, we expect that Cchek™ could be used in conjunction with or instead of PSA for screening.
Commercial Considerations: Cchek™ is a blood test that is fast and does not require advanced preparation by the patient. Therefore, it is similar to the PSA test and ITUS believes a combination of PSA and Cchek™ will be a much better way to detect prostate cancer and will significantly reduce the number of unnecessary biopsies.
Dr. Amit Kumar, CEO of ITUS stated, "While we have chosen prostate for our first commercial effort, we will continue to test other tumor types as they come in from our collaborators. However, our goal is to create a bolus of data on prostate cancer with which we can engage in discussions with regulators. A key component of this data package is going to be how well Cchek™ is able to classify benign conditions like benign prostate hyperplasia (BPH). BPH is the most common inflammatory disease of the prostate, and while it is a disease of the prostate gland, it is not a malignancy requiring a biopsy. We hope our results with benign conditions are as good as our results with cancer." Dr. Kumar continued, "It's important to highlight that there has been a lot of press around recent studies of liquid biopsies for early cancer detection. I want to note that our studies have shown comparable and often better data, even though our sample size is small. I also want to note that most other studies have not considered benign conditions."
ITUS Corporation ITUS, a cancer-focused biotechnology company, is harnessing the body's immune system in the fight against cancer. Its wholly owned subsidiary, Anixa Diagnostics Corporation, is developing the Cchek™ platform, a series of non-invasive blood tests for the early detection of solid tumor based cancers, which is based on the body's immunological response to the presence of a malignancy. Its majority owned subsidiary, Certainty Therapeutics, Inc., is developing CAR-T based immuno-therapy drugs which genetically engineer a patient's own immune cells to fight cancer. ITUS also continually examines emerging technologies in complementary or related fields for further development and commercialization. Additional information is available at www.ITUScorp.com.
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