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
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. (Credit: Tumisu/Pixabay.)
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 covidtesting@provistadx.com.
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)
Source: Company Press Release