LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.

Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.

Data from a newly published case series underscores the effectiveness of Cytosorbents Corp.’s blood purification technology in treating critically ill COVID-19 patients.

Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.

CAJICA, Colombia – Cuba’s Finlay Institute of Vaccines is moving forward with Soberana 2, a domestically developed conjugate vaccine against SARS-CoV-2. This is the second vaccine under development in the small country of 12 million people.