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WHO COVID-19 Initiative Enters Sublicense Agreement for COVID Serology Test

NEW YORK – The World Health Organization's COVID-19 Technology Access Pool (C-TAP) initiative has entered into a nonexclusive sublicense agreement with Biotech Africa to manufacture a serology assay to detect previous SARS-CoV-2 infection.

The assay detects anti-SARS-CoV-2 antibodies developed in response to COVID-19 infection or vaccination.

The nonexclusive sublicense agreement was formed between South Africa-based Biotech Africa and the WHO's Medicines Patent Pool under the auspices of C-TAP, according to a statement from WHO. The sublicense allows Biotech Africa to manufacture and commercialize a COVID-19 serology test that was previously licensed by WHO and MPP from Spain’s National Research Council, also called CSIC.

The agreement covers all related patents and biological material needed to manufacture the test, and CSIC will provide know-how and training to Biotech Africa. The license will be royalty-free for low- and middle-income countries and will remain valid until the date the last patent expires.

C-TAP was founded in 2020 to facilitate equitable and affordable access to COVID-19 therapeutics, diagnostics, vaccines, and other health technologies. It is a "global one-stop-shop for developers" to share knowledge and data, WHO said, and to license intellectual property to manufacturers through nonexclusive and transparent licenses. By pooling technologies, developers of COVID-19 health products can boost manufacturing capacity in all regions and expand access to lifesaving tools, WHO added.

"This new agreement means we can take advantage of untapped manufacturing capacity so more people in more countries can have easier access to affordable diagnostics," WHO Director-General Tedros Adhanom Ghebreyesus said in a statement.

Jenny Leslie, Biotech Africa's chief operations officer, noted that the firm is the first biotechnology company in Africa to collaborate with C-TAP to facilitate the local manufacture of affordable COVID-19 surveillance devices.

"This recognition is a product of our perseverance and dedication to become a global player in the manufacture of the highest quality recombinant proteins," Leslie said, adding, "The signing of this agreement emphasizes the company's ongoing goal to support diagnostics needs around the world."

The US recently agreed to provide 11 federally-funded technologies to C-TAP. These include a Chelex resin-based sample prep technology, a pooled sequencing-based test, and a point-of-care molecular technology called RNase-H-assisted detection assay for RNA, or RADAR.