An investigational drug, M-B1, demonstrates 80% accuracy vs. 50% accuracy for the current gold standard, reports Todos Medical at the ASCO meeting in Chicago.
What is TM-B1?
TM-B1 is an assay 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. The results are initially intended to be used in conjunction with other common diagnostic tests as part of breast cancer screening.
The results of the 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 ranges 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. The significant data has led to partnering opportunities in Asia.
The CEO of Todos Medical, Dr. Herman Weiss, stated “This is an important step as we further refine our initial intended use statements for commercial launch and being to provide valuable information to physicians so that they make better decisions with regards to management of patients with dense breasts.”
Founded in Israel in 2009, Todos Medical team is a multidisciplinary group that includes experts in medicine, physics, biochemistry, digital signal processing and electrical engineering. Traded over the country as TOMDF, they are headquartered in Rehovot. They are 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.