Todos Medical Announces Positive Clinical Trial Data for Breast Cancer Blood Test TM-B1 in Dense Breasts
- TM-B1 demonstrates 80% accuracy vs. 50% accuracy for current gold standard
- Todos Medical to attend 2019 ASCO Annual Meeting in Chicago, IL
REHOVOT, Israel, June 03, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTCQB: TOMDF) (http://www.Todosmedical.com) today announced positive results from a clinical trial completed at CGH Hospital in Singapore. The trial related to the Company’s proprietary TM-B1 Assay for breast cancer screening, initiated in July 2016. The trial was prospective, two arms, enrolling 257 female patients over a period of over 2 years. The study was focused primarily on subjects of Asian descent, a population in which women have the highest rate of dense breast tissue. In patients with dense breasts, mammograms typically result in inconclusive results, leading patients to be referred for additional invasive tests, such as biopsy.
The results of the TM-B1 trial presented a high degree of accuracy of more than 80% with respect to identifying healthy and benign versus malignant breast tumor in women tested. The current standard of care is estimated to range from 50% accuracy in women with dense breasts and an accuracy rate of 75% in the standard population. TM-B1 results were compared against gold standard breast cancer screening methods, such as mammography, ultrasound and biopsy. As a result of this data, we are evaluating partnering opportunities in Asia.
“This trial is an important step as we further refine our initial intended use statements for commercial launch and begin to provide valuable information to physicians so that they may make better decisions with regards to management of patients with dense breasts,” said Dr. Herman Weiss, Chief Executive Officer of Todos Medical. “We believe that our target of bringing the TM-B1 blood test to be accepted as a standard of care test for general breast cancer screening worldwide remains the long-term goal for Todos. We are pleased with the results as they demonstrate TM-B1’s accuracy in the Asian population, where it is estimated that women have the highest rate of dense breast tissue. These results are comparable to those we received in our Israeli trials for the same test and provides a strong support for the further development of our TBIA platform in other cancer indications, like our TM-C1 for colon cancer detection.”
Todos Medical to Attend 2019 American Society of Clinical Oncology
Dr. Colin Bier, board member of Todos Medical will be attending the 2019 ASCO annual meeting in Chicago, IL. Founded in 1964, the American Society of Clinical Oncology is the world's leading professional organization for physicians and oncology professionals caring for people with cancer.
About TM-B1 Breast Cancer Blood Test
The TM-B1 assay is indicated for women aged 25 years and older without a diagnosis of inflammatory disease. The assay is intended to be used as a diagnostic method to indicate whether or not a breast malignancy is present. TM-B1 results are initially intended to be used in conjunction with other common diagnostic tests as part of breast cancer screening.
About Todos Medical
Todos Medical Ltd. (OTCQB: TOMDF), an Israeli company headquartered in Rehovot, is an in-vitro-diagnostic company engaging in the development of a series of blood tests for the early detection of a variety of cancers and neurodegenerative disorders, such as Alzheimer's disease. The company has developed two cancer screening tests based on TBIA, a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2 are CE marked in the EU.
For more information, the content of which is not part of this press release, please visit http://www.Todosmedical.com.
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
Todos Medical Ltd.
Released June 3, 2019