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AI-based blood testing
October 2019
by Ilene Schneider  |  Email the author
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REHOVOT, Israel—Todos Medical Ltd., a clinical-stage in-vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, is expanding the distribution of its products by means of two recent agreements.  In addition, Todos announced positive results for its proprietary TM-B1 Assay.
 
Specifically, Todos Medical shared positive results earlier this year from a clinical trial for the TM-B1 Assay for breast cancer screening completed at CGH Hospital in Singapore.
 
The prospective trial, which began in 2016, had two arms enrolling 257 female patients over a period of over two years and 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, mammography can be inconclusive, 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 percent in identifying healthy and benign versus malignant breast tumor in women tested. The current standard of care is estimated to range from 50-percent accuracy in women with dense breasts and an accuracy rate of 75 percent 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, Todos Medical began to evaluate partnering opportunities in Asia.
 
After examining its options, Todos Medical entered into a binding term sheet with HWH World Pte Ltd., a wholly owned subsidiary of Singapore eDevelopment. Todos granted exclusive marketing rights for its TM-B1 and TM-B2 tests to HWH World’s network of members in Singapore, Malaysia, the Philippines, Vietnam, Thailand, Indonesia, South Korea, Hong Kong, China, the United States and Canada. HWH World, a marketing firm focusing on health and wellness, will work closely with Todos Medical to achieve regulatory approval in Singapore, where Todos Medical recently completed clinical studies, and then expand into other markets. Under the terms of the agreement, Todos Medical can partner with other companies to market and distribute its diagnostic tests through traditional means, including direct to consumer, through physicians, hospitals and/or government health systems.
 
Dr. Herman Weiss, president and CEO of Todos Medical, said, “Having just completed a substantial clinical study in Singapore that demonstrated the superiority of our assay versus mammography in prospectively classifying cancer and non-cancer subjects, especially among those with inconclusive mammogram results (BI-RADS III/IV), we are pleased to secure our first Asian partner in HWH World.  Our two companies are aligned in viewing the significant value by utilizing a blood test that will determine whether a biopsy is necessary in breast cancer.”
 
“Todos Medical’s innovative artificial intelligence-based blood testing technology has shown strong results for breast cancer screening and diagnosis in Singapore. This represents a tremendous opportunity for HWH World members to take control of their healthcare by getting better information about potential cancer to ensure they are seeking treatment early in the disease progression,” added Heng Fai Chan, chairman of HWH World. “This will improve the well-being of our female members and help differentiate us from other wellness programs in the market. Many Asian women are forced to have unnecessary breast biopsies because mammograms are not very effective in this population. Todos has identified a solution to this problem, and HWH World is looking forward to bringing the TM-B1 and TM-B2 tests to our members, both in Asia and as we expand into North America.”
 
Todos Medical also entered into a non-binding memorandum of understanding (MOU) with Orot+,  the operational division of Orot-Luces, to expand the existing launch and distribution partnership for the commercial sale of Todos’ early breast cancer detection blood tests TM-B1 and TM-B2 into Japan. Orot+ has agreed to spend a minimum of $2.5 million toward clinical development, regulatory approval and commercial launch of the tests via a soon-to-be-formed Japanese Distribution Company that will have exclusive rights to sell and distribute TM-B1 and TM-B2 in Japan. The MOU expands the relationship between the two companies, which signed a definitive exclusive distribution agreement for both of TM-B1 and TM-B2 in Romania and Austria in April 2019.
 
Weiss said that Todos Medical is “excited to expand our commercialization network for TM-B1 and TM-B2 into Japan” and “especially happy we are again partnering with Orot+, who will drive the market launch and distribution efforts.” He added that the company’s blood tests “are designed to detect the presence of breast cancer at early stages of disease, and we know that early diagnosis and treatment greatly improves patient outcomes.”
 
According to Weiss, “Japan, like much of Asia, has an enhanced need for alternatives to mammogram as the primary breast cancer diagnostic, due to the high incidence of women with dense breast tissue, making this an especially important market for us.”
 
Ron Streichman, CEO of Orot-Luces, remarked, “We are satisfied that Todos has recognized our unique market position and decided to partner with us to launch their cancer detection blood test in the Japanese market. While Japan has the world’s second-largest economy, there are serious unmet needs in cancer care. Orot is focused on offering unique and customized diagnostic solutions.”
 
Code: E101902

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