(Photos courtesy of Ortho)
Last year, Ortho Clinical Diagnostics made a conscious decision to participate in the war against the coronavirus, creating the first high-volume COVID-19 antigen and antibody tests to receive emergency authorization. Today, the local facility continues to play an instrumental role in that fight, recently winning a $53.7 million federal contract.
The Defense Department award, on behalf of and in coordination with the Biomedical Advanced Research and Development Authority, will fund manufacturing capacity expansion for U.S. customers of Ortho’s COVID antigen and two antibody tests, and for the company’s Vitros System laboratory instruments, which help detect active and past coronavirus infections. Ortho expects to deliver more than 6.7 million COVID tests per month in the U.S. market by April 2022.
Once part of Kodak, Ortho’s presence in Rochester spans three facilities at Canal Ponds in Greece, employing roughly 1,200 employees. The new contract will add 30 jobs in both manufacturing and research and development, and increase speed to market, officials say.
“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,” says Chris Smith, chairman and CEO of Ortho.
Ortho was owned by the Carlyle Group, a private equity firm, which bought the health care, screening, diagnostic and monitoring company from Johnson & Johnson in 2014 for more than $4 billion. In January, Ortho went public and now trades on NASDAQ with the ticker symbol OCDX.
Johnson & Johnson had purchased the Kodak unit in 1994. At that time, Ortho was widely known for its ability to determine Rh+ or Rh- blood type.
Given its expertise in this space, Tony Allen, head of operations for Ortho’s Rochester site, says the pandemic prompted the company to repurpose and realign itself to make a difference. Rochester researchers developed a COVID test based on a successful, existing platform. The company’s foray into COVID testing attracted $678,000 from BARDA last June, which was followed by another $12.85 million last September, for development of Ortho’s SARS-CoV-2 antigen test for the rapid detection of the virus and continued longer-term regulatory pathway support for Ortho’s antibody tests, the company says.
“They saw how we were progressing and the quality of our products, the quality, the sensitivity (and) especially specificity of the product,” says Allen, adding that the conversation then shifted to manufacturing capability and capacity for future use, leading to the continued partnership with BARDA.
Ortho’s facilities here manufacture fluids and its Vitros XT Microslide assays. These tests help labs detect antibodies and antigens, or detect and measure the amount of substance, hormone, or clinical marker in a patient sample.
The Vitros SARS-CoV-2 Antigen Test is a laboratory immunoassay for the in-vitro qualitative detection of the SARS-CoV-2 nucleocapsid antigen. Immunoassays are tests that rely on the ability of an antibody to bind to a specific structure. With the Ortho test, results are reported as either reactive (positive) or non-reactive (negative) on the same day, alleviating lab backlog. It can determine when an individual is infectious as well, with high sensitivity and specificity. Up to 130 tests per hour can be processed on a single Vitros analyzer. More than 1,000 labs in the United States house these analyzers, including rural regions.
The antigen test is an alternative to polymerase chain reaction, or PCR, testing, which at the onset of the pandemic was considered the gold standard. Allen says the Vitros SARS-CoV-2 Antigen Test scores major points over PCR, especially when it comes to testing speed. Labs that use Ortho’s Vitros analyzers can easily conduct many tests whereas the cost of PCR testing and its accessibility, particularly in rural areas, has been challenging. And, a month ago, a PCR test was ineffective in detecting a virus variant in France.
“They’re comparable in terms of sensitivity and specificity, there’s no doubt about that,” Allen says. “But in terms of being able to test them fast, get good throughput, and get results back to the patients, we’re way ahead of PCR.”
Ortho’s Total antibody test aims to find recent or prior coronavirus infections, detecting all COVID-related antibodies, while its COVID IgG antibody test can detect the IgG antibody, which can be present in a patient’s blood at a later stage of infection and remain at a high level even after recovery.
Allen recalls how Ortho employees “burned the midnight oil” for several months to ensure the quality, specificity and stability of these tests to get it to a point where the team was confident these tests could offer accurate results.
“We had R&D scientists working literally 24 hours, seven days a week. We were eating, drinking and sleeping on site,” he says. “When it came to releasing the product, we took the best of operators and formulators and scientists from the manufacturing environment and transferred them into that process. And they went through the same thing … working the weekends and shipping and ensuring everything was correct. And it was also the support services associated with it, quality control and such.”
Adds Allen: “One of our core values is ‘every test is a life.’ So, we wanted to continue that core value right through into our COVID testing also. We wanted to make sure we were continuing the trust with our customers and our patients and that we develop and ship a very reliable product. That’s why we got very good feedback and continue to get very, very good feedback from various labs and hospitals.”
It remains a very exciting time at the sites in Rochester. Ortho is still shipping its tests and is fine-tuning its efforts to detect variants of the COVID virus. The company is back to its pre-COVID level of activity.
Allen, who is extremely proud of the local team, says the work and the federal contracts have “fueled the future for Rochester.”
“It’s an exciting, busy time,” he says. “I think everybody in the company in Rochester, that’s the way they want to be.”
Smriti Jacob is Rochester Beacon managing editor.