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Ortho Clinical Diagnostics to Expand COVID-19 Test Production With $53.7M BARDA, DoD Contract

NEW YORK ─ Ortho Clinical Diagnostics said on Wednesday that it anticipates the award of a $53.7 million US government agency contract to support a more than threefold increase in US production of its COVID-19 antibody and antigen diagnostic tests.

The US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defense (DoD) have awarded Ortho an undefinitized contract that will lead to the $53.7 million award under a separate contract to accelerate test production, the Raritan, New Jersey-based company said.

The funding will support capacity expansion to provide up to 6.7 million COVID-19 tests per month for the US market by the second quarter of 2022, Ortho added.

Ortho expects to expand production of its Vitros Systems and two COVID-19 antibody tests – Total and IgG – as well as its Vitros SARS-CoV-2 Antigen Test, which received US Food and Drug Administration Emergency Use Authorization in January.

US government agencies use undefinitized contracts when one or more elements of a contract cannot be agreed upon and there is an urgent need to begin production. The new contract to support production expansion is part of BARDA's and the federal government's ongoing COVID-19 medical countermeasure development efforts, Ortho said.

Ortho's partnership with BARDA and the DoD "underscores the continued and critical importance of bolstering the nation's testing infrastructure," Chris Smith, chairman and CEO of Ortho, said in a statement. Ortho's high-volume tests are being used by US hospitals, reference labs, and public health organizations, particularly in rural and underserved communities, he added.