Due an error by Todos Medical, 3D Medicines was incorrectly identified as 3D Biomedicine Science & Technology in an earlier version of this article. We have corrected the company name.
NEW YORK – Todos Medical said Thursday it has inked an exclusive agreement with Gibraltar Brothers & Associates to distribute a rapid point-of-care kit in the US and Israel that detects antibodies against SARS-CoV-2, the coronavirus that causes COVID-19.
Gibraltar Brothers is a US-based subsidiary of China-based Shanghai Liangrun Biomedicine Technology, the test supplier.
Financial and other terms of the agreement were not disclosed.
The test, called Colloidal Gold, which uses colloidal gold immunochromatography, can provide results in less than 10 minutes at the point of care, using blood from a fingerprick, according to Rehovot, Israel-based Todos.
The test has demonstrated 90.4 percent sensitivity and 100 percent specificity in a Chinese clinical trial located in Wuhan where the coronavirus disease COVID-19 outbreak originated. Investigators evaluated Colloidal Gold using 188 blood samples obtained from patients with clinically confirmed COVID-19 and 182 non-SARS-CoV-2 infected patients.
The test has received CE marking and Chinese National Medical Products Administration (NMPA) approval to detect the coronavirus, Todos said.
It anticipates pursuing US Food and Drug Administration Emergency Use Authorization for the test.
Jorge Leon, chief medical advisor for Todos, said that the "IgM antibody response to the SARS-CoV-2 virus appears at days [five to six] after infection, showing recent exposure to the virus, and lasts for up to three weeks."
He added that it "is an important test to increase the window of diagnostic sensitivity of true positive cases since [a] molecular test…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.
Shanghai Liangrun Biomedicine has shipped test kits to Todos for validation. The Chinese firm has 500,000 Colloidal Gold test kits in stock and has indicated it can manufacture up to 300,000 test kits per day to help meet demand in the US. Todos said it will validate the assay in the US in the coming weeks in preparation for initial commercial launch as a laboratory-developed test. It will use Provista Diagnostics' lab in Alpharetta, Georgia to conduct validation activities.
Todos said that the rapid test could be used to triage and quarantine patients as quickly as possible after detection. A nurse practitioner can conduct the test in a doctor’s office or clinic, the firm said, but its distribution focus will be on nursing homes and senior care centers.
Todos noted that it has inked an exclusive option agreement to acquire Provista and anticipates the transaction will close in the second quarter of this year.
Because Colloidal Gold tests for antibodies to SARS-CoV-2, the test will complement a nucleic acid test that Todos is also validating, the firm said.
Todos Medical said Tuesday it has inked a non-exclusive agreement for distribution in the US and Israel of 3D Medicines' 3DMed 2019-nCoV Detection Kit, 3DMed 2019-nCoV & Flu A/B Detection Kit, and Andis350 3DMed Automated Solution real-time PCR machine.