Ortho Clinical Diagnostics Honored by Blood Centers of America for Critical Contributions During COVID-19 Pandemic

Recognition Applauds Mass-Scale Antibody and Antigen Tests

Ortho Clinical Diagnostics (NASDAQ: OCDX), one of the world’s largest pure-play in vitro diagnostics (IVD) companies, has been recognized by Blood Centers of America (BCA) with its Critical Infusion Award for helping the BCA overcome the unique challenges the pandemic posed to the blood and plasma donation field. Ortho is one of 10 suppliers recognized with the award.

As providers of over 50% of the total American blood supply, BCA members and affiliated community blood centers led the way in collecting convalescent plasma (CCP), a blood product that carries infection-fighting antibodies from people who have recovered from COVID-19, for early COVID-19 treatments. The centers ultimately collected more than 20,000 doses per week.

Ortho was recognized with the Critical Infusion Award for its role in helping the BCA ensure the availability of CCP while helping to maintain a secure and stable supply of blood and plasma for hospitals. Ortho’s antigen test, designed to detect active infection with utility for mass-scale testing, was also lauded by the BCA, which called it a “critical asset readily available at centers across the country during the pandemic.”

“Since the beginning of the pandemic, Ortho Clinical Diagnostics has not stopped working to ensure our partners and the communities they serve are equipped with diagnostic tools capable of mass-scale testing that yields accurate, trusted results,” said Warren Stone, president, Americas, Ortho Clinical Diagnostics. “We are humbled to be recognized for our contribution and Because Every Test Is A Life™ will continue to innovate so that our partners like the BCA can continue their life-saving work.”

When the U.S. Food and Drug Administration issued its Emergency Use Authorization (EUA) for the use of COVID-19 convalescent plasma to be used for the treatment of hospitalized patients, it required all donor blood units be tested with Ortho’s COVID-19 IgG antibody test as a manufacturing step before release to hospitals and patients.

As part of the National Expanded Access Program (EAP) sponsored by the Mayo Clinic, which was the basis of the FDA EUA, donor units tested by Ortho’s COVID-19 IgG antibody test that were found to have high levels of antibodies against SARS-CoV-2 were categorized as high titer COVID-19 convalescent plasma, thought to be most beneficial for critically ill patients.

BCA works with hundreds of suppliers that kept the supply chain moving during critical months of the pandemic, but recipients of the Critical Infusion Award stood out for going above and beyond to solve logistics, testing and equipment supply challenges.

“We received so many thank you notes from grateful patients that received CCP and felt that it saved their lives,” said John Hagins, BCA Board Chairman.” BCA and its member blood centers recognize that we could not have collected and distributed CCP to patients in need without our supplier partners supporting us behind the scenes.”

“The pandemic did not stop the demand for blood and plasma donations – in fact, it significantly increased it in some cases. We are so grateful for our partners across the supply chain, who all kept these critical supplies moving despite significant, unprecedented challenges,” said BCA President and CEO Bill Block. “Congratulations to our Critical Infusion Award recipients. We commend your resiliency and flexibility throughout the COVID-19 pandemic.”

About Ortho’s VITROS® COVID-19 Testing Solutions

Authorized for use in the U.S. in January 2021, Ortho’s VITROS® SARS-CoV-2 Antigen Test offers reliable detection of acute COVID-19 infection with high sensitivity and specificity. With utility for mass-scale testing and same-day results for labs, Ortho’s antigen test can be processed at a rate of up to 130 tests per hour on a single analyzer, bolstering the ability of hospitals and reference labs to address testing backlogs, supply shortages, and delayed results that have undermined previous testing efforts. The VITROS® SARS-CoV-2 Antigen Test also offers a practical and cost-effective testing alternative to polymerase-chain reaction (PCR) tests, which, while highly accurate, can be expensive and require long processing times during testing surges.

Ortho’s Total Antibody Test, designed to indicate recent or prior SARS-CoV-2 infection, detects all COVID-19 related antibodies (IgA, IgM and IgG). The company’s COVID-19 IgG antibody test detects the IgG antibody, which appears in a patient's blood in the later phase of infection and remains elevated even after recovery. Offering high sensitivity and specificity, both the Total and IgG tests – which have FDA EUA and CE Mark – provide public health leaders with an exceptional tool in tracking viral community spread, bolstering serological surveillance efforts, and managing patient treatment pathways.

The tests – including Antigen, IgG, and Total – are processed on Ortho’s trusted VITROS® system, which is already installed in more than 1,000 labs across all 50 states in the U.S. This includes more than 500 analyzers located in rural regions, where coronavirus testing needs are especially urgent.

Questions from laboratories, health care providers, or government officials regarding Ortho’s COVID-19 solutions can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. 

^{The VITROS Anti-SARS-CoV-2 Total and IgG Antibody Tests and the VITROS SARS-CoV-2 Antigen Test have not been cleared or approved by the U.S Food and Drug Administration (FDA). They have been authorized by the FDA under an Emergency Use Authorization (EUA) and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate- or high-complexity tests. The VITROS antibody tests have been authorized only for the detection of either total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. The VITROS antigen test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.}

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies.

More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life™, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs.

From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years.

The company is powered by Ortho Care™, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.

About Blood Centers of America

Blood Centers of America (BCA) is the largest blood supply network in the U.S., uniquely positioned to sustain, mobilize, and advocate for the nation's blood supply. Our 60+ independent community blood centers collect and distribute over 50% of the blood supply in the US, delivering reliable service with a profound commitment to the communities we serve. Recently, in response to the COVID-19 pandemic, we have helped spur lifesaving donations of convalescent plasma, which carries infection-fighting antibodies from people who have recovered from COVID-19.