NEW YORK – In vitro diagnostic company 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.
The testing products, developed by China-based 3D Medicines, have received CE marking and approval from the Chinese National Medical Products Administration, according to Rehovot, Israel-based Todos.
Todos said 3D Medicines' test demonstrated 99.3 percent sensitivity and 100 percent specificity in a Chinese clinical trial and that the 3D Medicines' technology has completed more than 100,000 tests in Wuhan, China, where the coronavirus disease COVID-19 outbreak originated.
Todos further said that it has partnered with Provista Diagnostics in the US to use Provista's lab in Alpharetta, Georgia, to conduct CLIA validation required to launch the test in the US. 3D Medicines has shipped materials to the Provista lab to support validation over the coming weeks.
In January, Todos announced it had entered into an exclusive option agreement to acquire Provista.
Combining influenza A and B testing with coronavirus testing is "clinically meaningful" because of the extended flu season in the US "that will create additional doubt among healthcare providers regarding the cause of symptoms for patients," Jorge Leon, a chief medical advisor to Todos, said in a statement.
Todos said it anticipates targeting nursing homes and senior-care centers for product distribution and will ensure that governments have access to its testing.
Further, 3D Medicines is in discussions with the FDA about regulatory approvals for its products, according to Todos.