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Rochester’s Ortho Clinical Diagnostics has been awarded a $53.7 million contract from the U.S. Department of Defense to fund manufacturing capacity expansion dedicated to U.S. customers of the company’s COVID-19 antigen and two antibody tests and for the company’s VITROS System laboratory instruments.
Ortho Clinical, one of the world’s largest pure-play IVD companies, created the first high-volume, COVID-19 antigen and antibody tests to receive Food and Drug Administration (FDA) Emergency Use Authorization at Ortho’s Global Center of Excellence for R&D in Rochester, providing mass-scale testing solutions at the height of the pandemic.
The DoD contract is on behalf of and in coordination with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
“Ortho Clinical Diagnostics has been a fixture in Rochester for over three decades, and we consider it an honor to support the nation with high-quality laboratory analyzers and highly accurate COVID-19 tests as we return to our ‘new normal’ and reopen the world,” said Tony Allen, head of operations for Ortho’s Rochester site. “The continued support from BARDA and DoD is a significant investment in Ortho’s local R&D and operations infrastructure, but equally significant to the local economy and community.”
In June 2020, BARDA awarded Ortho $678,000 in support of the company’s COVID-19 antibody testing program, followed by an additional $12.85 million in September 2020 to support the development of the company’s SARS-CoV-2 antigen test, a diagnostic test designed for the rapid detection of the virus that causes COVID-19 and continued longer-term regulatory pathway support for Ortho’s antibody tests.
The company expects to deliver more than 6.7 million COVID-19 tests per month to the U.S. market by April 2022.
“I’m thrilled that Ortho Clinical Diagnostics has received this significant award that is a testament to their national leadership in the high-tech innovation sector,” said U.S. Rep. Joe Morelle, D-Irondequoit. “Not only is their work critical to strengthening our economy, it is helping our local efforts to fight this pandemic and revitalize our communities. I’m grateful for their longstanding commitment to supporting Rochester and congratulate their team on this exciting opportunity.”
Ortho’s Rochester facilities manufacture fluids and proprietary VITROS XT Microslide assays, which help labs test for antibodies and antigens or detect and measure the amount of substance, hormone or clinical marker in the sample. VITROS XT MicroSlides allow two tests typically performed together — like glucose and calcium — to be performed on the same slide, allowing labs to get results faster.
Ortho Clinical Diagnostics operates three facilities, including two manufacturing facilities and an administrative building, at Canal Ponds in Rochester, which collectively employ some 1,200 people. The new contract will add 30 jobs in both manufacturing and R&D. Ortho Clinical Diagnostics formerly was Clinical Diagnostics Inc., a division of Eastman Kodak Co. before Johnson & Johnson purchased it in 1994.
“Ortho’s ongoing partnership with BARDA and DoD to significantly expand our COVID-19 testing manufacturing capabilities underscores the continued and critical importance of bolstering the nation’s testing infrastructure by leveraging highly accurate, automated and scalable diagnostic and serological tests that are FDA emergency use authorized,” said Ortho Clinical Chairman and CEO Chris Smith. “Our high-volume testing solutions have already been an indispensable asset for hospitals, reference labs and public health leaders across the country, particularly in rural and underserved communities. We look forward to expanding the availability of these testing solutions to communities in need.”
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