Israel-based in vitro diagnostics company Todos Medical has expanded the agreement with 3D Medicines for Covid-19 testing products.
As part of the newly signed medical device contract manufacturing agreement, Todos has obtained the exclusive right to seek out US Food and Drug Administration (FDA) emergency use authorisation (EUA) for 3D Med’s SARS-CoV-19.
The company also acquired exclusive branding and distribution rights to 3D Med’s qPCR test kits in the US.
3D Med recently expanded extraction reagent manufacturing capacity by adding 1,000,000 extraction reagent kits per week.
The additional extraction capacity is expected to increase the total US testing capacity per day by approximately 25%. Currently, the country’s testing volume is approximately 550,000 tests a day.
Todos has completed validation of 3D Med’s qPCR kits, pre-loaded extraction reagents and automated machines at its partner CLIA/CAP-certified lab Provista Diagnostics in Alpharetta.
Additionally, 3D Med has validated ‘pool testing’ at a ratio of 10:1. Todos plans to complete ‘pool testing’ validation in the US in the next few weeks to obtain US FDA EUA.
Todos Medical president and CEO Gerald Commissiong said: “It is now unequivocally clear that PCR testing is the gold standard in the US for the foreseeable future until new molecular technologies are able to reach the scale of current PCR testing.
“We are very pleased with the relationship we are building with 3D Med, especially as we see demand for extraction machines and reagents begin to really take off as smaller, independent labs begin to get involved in Covid-19 testing and they identify access to a stable supply of extraction reagents as the rate-limiting step to market entry.”
Meanwhile, Todos has also expanded the international distribution rights to 3D Med’s Covid-19 testing products to include the US, Israel, Singapore, Malaysia, Indonesia, Thailand, Myanmar, Vietnam, Philippine, Taiwan, India and the UK.