Breaking News: Todos Medical Signs Novel Coronavirus (COVID-19) Point-of-Care Rapid Antibody Testing Kit Exclusive Distribution Agreement for the United States and Israel with Shanghai Liangrun Subsidiary Gibraltar | Financial Buzz

Breaking News: Todos Medical Signs Novel Coronavirus (COVID-19) Point-of-Care Rapid Antibody Testing Kit Exclusive Distribution Agreement for the United States and Israel with Shanghai Liangrun Subsidiary Gibraltar

  • Colloidal Gold demonstrated 90.4% sensitivity and 100% specificity in Chinese clinical trial
  •  Provides results in two to 10 minutes at the point of care using blood from a finger prick
  •  CE Mark and Chinese National Medical Products Administration (NMPA) approval have been received; Todos will pursue U.S. FDA approval 

Todos Medical Ltd. (OTCQB: TOMDF), a pre-commercial stage in-vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, today announced it has entered into an exclusive distribution agreement for the United States and Israel (the “Distribution Agreement”) with Gibraltar Brothers & Associates, LLC, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology Co. (“Shanghai”), for its proprietary colloidal gold immunochromatography test (“Colloidal Gold”). 

Colloidal Gold has been approved as a diagnostic test for the novel coronavirus (COVID-19) in China by the NMPA (formerly the China FDA) and in Europe under a CE Mark. Todos will be responsible for obtaining U.S. Food and Drug Administration (FDA) approval and plans to do so under the Emergency Use Authorization Program. 

Shanghai has shipped test kits for validation by Todos. During the four-week validation process, Todos intends to place its first purchase order based upon the market demand identified. Shanghai currently has 500,000 Colloidal Gold test kits in stock, and has indicated to Todos that it can manufacture up to 300,000 test kits per day to help meet the demand in the U.S., given that demand for test kits in China has begun to decline.



The Colloidal Gold point-of-care (POC) test kit uses a drop of blood from a finger prick to test for antibodies to COVID-19.  The test kit contains a detection kit, a lancet, a disinfectant wipe, a micropipette, a cotton ball and the reagent.  The kit comes in a sealed plastic bag and includes instructions; the only thing not included is a timer.  This is a rapid test that takes between two and 10 minutes to obtain results, compared with the nasal swab test currently in widespread use that takes two to three days for results.  

“I’m pleased to see Todos take on the task of bringing additional COVID-19 testing capacity into the United States, where we expect significant demand in the coming months as we grapple with the international pandemic,” said Jorge Leon, Ph.D., Chief Medical Advisor to Todos. “The IgM antibody response to the SARS-CoV-2 virus appears at days 5-6 after infection showing recent exposure to the virus, and lasts for up to three weeks, therefore it is an important test to increase the window of diagnostic sensitivity of true positive cases since the molecular test (nucleic acid test), despite being the gold standard,  is not always positive in some patients during the early course of infection. The IgG antibody response peaks at day 21 and lasts for years, indicating the patient was infected with the virus. The Colloidal Gold IgM/IgG tests has become a very important test in the coronavirus testing paradigm, and we will be working to validate the assay here in the United States in the coming weeks in preparation for commercial launch under CLIA and parallel interactions with U.S. federal authorities to expedite its path to FDA approval using the recently enacted Emergency Use Authorization Program. Because Colloidal Gold tests for antibodies to the virus that causes COVID-19 (SARS-CoV-2), instead of testing for the virus itself, this test will be different and complementary to the nucleic acid test Todos will be validating in parallel. Validating and making available the Colloidal Gold and lab-based molecular testing together or in parallel has the potential to create a new paradigm in the screening for COVID-19 that we believe may allow for EUA from US FDA for Colloidal Gold POC test kit.”

Todos and Provista Diagnostics, Inc. have agreed to use Provista’s lab in Alpharetta, Georgia to conduct the validation required to launch the test in the U.S. under CLIA. Todos entered into an exclusive option to acquire Provista, and this transaction is expected to close in the second quarter of 2020. All COVID-19 testing inquiries should be directed via email to 

Rao Mulpuri, Ph.D., Chief Operating Officer of Provista, commented, “We are very pleased to help validate and ultimately offer this new, more comprehensive testing paradigm to meet the needs of our country during this COVID-19 crisis.”  

“In these extraordinary times, the value of widespread medical testing has become clearer than ever.  We are proud to use our business development expertise to identify multiple solutions that together have the potential to significantly increase testing accuracy and capacity in the U.S. by screening large numbers of patients in places where traditional lab testing methods may not be able to meet the demand,” said Gerald Commissiong, President & CEO of Todos Medical. 

“The concept behind a rapid test is to triage and quarantine the patient as quickly as possible after detection,” he added.  “This test can be done at a doctor’s office or in a clinic by a nurse practitioner, but we are particularly focused on nursing homes and senior care centers.  These locations typically house seniors with underlying medical conditions that make them the most at-risk population due to lack of mobility.  Through testing we believe communities can quickly identify infections earlier and limit a group’s overall exposure to COVID-19, which is particularly deadly in this demographic. There are more than 65 million Americans over the age of 65, and this is one of the most at-risk populations for whom we must ensure early detection. We also are looking to ensure solutions for various government organizations, self-insured employers, small businesses as well as other groups who need access to testing.”

Clinical Results from Clinical Trial in Wuhan, China

All samples were tested using the Colloidal Gold diagnostic device, and the results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs and symptoms) of Novel Coronavirus. Colloidal Gold was evaluated with 188 blood samples obtained from clinically confirmed COVID-19 patients from multiple Chinese Hospitals and the Chinese CDC laboratories (positive), as well as 182 non-SARS-CoV-2 infected patients (negative). The results were:

  •  Sensitivity (positive): 90.43% (170/182)
  •  Specificity (negative): 100% (182/182) 

About Novel Coronavirus (COVID-19)

Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries. COVID-19 is the disease caused SARS-CoV-2.

About Todos Medical Ltd.

Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer’s disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), 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, have received the CE mark. Todos owns 19.99% of Breakthrough Diagnostics, Inc., a joint venture with Amarantus Bioscience Holdings, Inc. (OTCPK:AMBS) that is developing the LymPro Test®, a blood test for diagnosing Alzheimer’s disease. Todos has exercised its option to acquire Breakthrough and expects to close on that transaction in the first half of 2020. Todos has also entered into an exclusive option to acquire breast cancer blood testing company Provista Diagnostics, Inc. that is commercializing the Videssa® breast cancer blood test. 

Todos has entered into a non-excusive distribution agreement with 3DMedicine Science & Technology Co (3DMed), a China-based cancer precision medicine company, for distribution in the US and Israel of 3DMed’s ANDiS® SARS-CoV-2 Detection Kit (COVID), ANDiS® SARS-CoV-2  & Influenza A/B Detection Kit (COVID/Flu) and its proprietary ANDiS®350 3DMed Automated Solution countertop real-time PCR machine (3D Machine). 3DMed’s COVID, COVID/Flu and 3D Machine have received a CE Mark in Europe. 3D Machine also has received approval from the Chinese FDA. 3DMed is currently engaged in discussions with the FDA regarding approval of its products.

Additionally, Todos has entered into an exclusive distribution agreement with Gibraltar Brothers & Associates, LLC, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology Co. (“Shanghai”), for its proprietary colloidal gold immunochromatography test (“Colloidal Gold”) Rapid Test for the novel coronavirus that can deliver test results in two to 10 minutes at point of care. Colloidal Gold has been approved as a diagnostic test for COVID-19 in China by the NMPA (formerly the China FDA) and in Europe under a CE Mark. Todos will be responsible for obtaining U.S. Food and Drug Administration (FDA) approval.

For more information, the content of which is not part of this press release, please visit

Sponsored Content Release. Click for Full Disclosure

  • Sponsored Content Release, a leading financial news informational web portal designed to provide the latest trends in Market News, Investing News, Personal Finance, Politics, Entertainment, in-depth broadcasts on Stock News, Market Analysis and Company Interviews. A pioneer in the financially driven digital space, video production and integration of social media, creates 100% unique original content. also provides financial news PR dissemination, branding, marketing and advertising for third parties for corporate news and original content through our unique media platform that includes Newswire Delivery, Digital Advertising, Social Media Relations, Video Production, Broadcasting, and Financial Publications.

    Please Note: is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on (the ‘Site’) is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content),, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. receives fees for producing and presenting high quality and sophisticated content on along with other financial news PR media services. does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. For todos medical ltd. video production, filming editing, news reporting, financial and corporate news dissemination, has signed a six-month agreement with the company. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. has agreed to five million restricted shares, will always disclose any compensation in securities or cash payments for financial news PR advertising. does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security., members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use, please visit: