Ortho’s VITROS® SARS-CoV-2 Antigen Test for Accurate, Mass-Scale COVID-19 Testing is the First High-Volume Test to Receive Authorization by Health Canada

Raritan, NJ

• Ortho’s VITROS® SARS-CoV-2 Antigen Test is the first high-volume COVID-19 antigen test to receive Authorization by Health Canada
• With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour
• The test is run on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world

RARITAN, N.J. (May 18, 2021) – Ortho Clinical Diagnostics (Nasdaq: OCDX), one of the world’s largest pure-play in vitro diagnostics companies, today announced that its VITROS® SARS-CoV-2 Antigen Test, designed to detect acute infection, has become the first high-volume COVID-19 antigen test to receive Authorization by Health Canada.

With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results.

“As the pandemic continues to devastate our communities and economy, laboratory professionals have been working under extraordinary circumstances to deliver critical COVID-19 testing data to patients, clinicians and communities,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. “Even as vaccine inoculation programs roll out, mass-scale testing remains an essential tool in fighting COVID-19. Ortho’s accurate, high-volume COVID-19 antigen test can play a pivotal role in the global response to this virus.”

About the VITROS® SARS-CoV-2 Antigen Test

The VITROS® SARS-CoV-2 Antigen Test produces accurateⁱ , clinically reliable results on Ortho’s high-volume VITROS® Systems, which are installed in over 5,600 laboratories around the world.

These analyzers normally run a broad menu of over 150 different tests from blood and body fluid samples, but now are also able to run samples derived from swabs. Additional analyzers are available for shipment and can be installed rapidly to further increase capacity since they don’t require an external water source to operate.

Ortho’s COVID-19 antigen test is an alternative to real-time polymerase chain reaction (PCR) testing, which although highly sensitive, can be expensive and require long processing times during testing surges.

Other COVID-19 diagnostic testing platforms, including rapid antigen tests, have limited capacity to run multiple tests simultaneously or require short time windows to read results, making it challenging to test more than a handful of patients at a time. Ortho is currently able to deliver several million tests per month.

About Ortho’s VITROS® COVID-19 Testing Solutions

Ortho’s new SARS-CoV-2 Antigen Test is the latest addition to the company’s COVID-19 solutions, which include two COVID-19 antibody tests — Total and IgG — both of which have FDA EUA and CE Mark.

Because Ortho’s VITROS Systems are already installed worldwide, reporting times may be further improved because lab staff require no additional training, and the instruments are already connected to existing laboratory information systems and software. These systems are self-contained and do not require an external water source to run.

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

For more information visit: https://www.orthoclinicaldiagnostics.com/global/covid19/.

About Ortho Clinical Diagnostics

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

More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life^TM, 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 among the first 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^TM, 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.