Todos Medical Announces Positive Clinical Trial Data for Breast Cancer Blood Test TM-B1 in Dense Breasts

In Clinical Trials by Barbara Jacoby

Source: Todos Medical Ltd.


Todos Medical Ltd. (OTCQB: TOMDF) ( 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.

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