Ortho Clinical Diagnostics Overview & Q&A

Ortho Clinical Diagnostics Overview & Q&A Interview


Michael S. Iskra, Executive Vice President of Commercial Excellence and Strategy at Ortho Clinical Diagnostics 

  1. For those not familiar with all the great work that you have been doing, can you give us a brief overview of your latest major achievement?

I’d be happy to. Hospitals, hospital networks, clinical laboratories and blood banks around the world count on us for our innovative technology and tools that ensure test results are fast, accurate and reliable.

Diagnostic test results are responsible for 70% of all medical decisions, and we are proud that our tests impact more than 800,000 patients each day. For us at Ortho, it’s about more than diagnostics — it’s about the impact we have on people — Because Every Test Is A Life.™ 

Like other companies in our industry, we focused our attention on helping our customers during the pandemic. When the world needed highly accurate COVID-19 diagnostic solutions, we leveraged the company’s 80+ years of experience and developed high-quality, highly accurate solutions that provided immediate utility for backlogged labs and communities across the world. In just 19 days, we went from concept to launch of our VITROS® COVID-19 Total COVID-19 total antibody test. Two weeks later, we received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for our VITROS® COVID-19 IgG antibody test.

Our tests were the first high-volume COVID-19 antibody and antigen tests with FDA Emergency Use Authorization. Both tests, which also have CE Mark, help clinicians understand whether a patient has been exposed to and developed antibodies to SARS-CoV-2 and offer high specificity, providing an extremely high level of confidence for both patients and clinicians. 

We continue to innovate to bring to market solutions that help labs and public health officials combat the pandemic, and I’ll go into more detail next. 

  1. Congrats on the EUA for your Total Nucleocapsid Antibody Test. Can you share more details about this?

Thank you so much. Our VITROS® Anti-SARS-CoV-2 Total N Test detects the individual’s immune response to the COVID-19 virus and is intended to help clinicians understand if their patient had a recent or prior COVID-19 infection. However, our N Test is only one assay in our VITROS® COVID-19 Testing Solutions, which include a quantitative test.  

We’ve been supporting our customers from the beginning of the pandemic with reliable, high-throughput testing solutions, including an antigen test and numerous antibody tests that offer SARS-CoV-2 infection and antibody testing on our trusted VITROS® Systems. Because they were already installed in more than 1,000 labs across all 50 states in the U.S. and in over 5,400 labs across the world, our customers were able to quickly process 150 antibody tests or up to 130 antigen tests each hour, helping deliver critical results fast. 

Now, with vaccine and booster programs broadly rolled out across the nation, health care teams are relying more heavily on antibody tests to measure immune response and deliver more personalized guidance for specific subsets of the population (immunocompromised people, the elderly, children). Especially in the more vulnerable populations, accurate measurement of immune response is critical when supporting decisions on lifestyle (to attend an event, go back to work, etc.) and population-specific studies.

As we shift away from a broad population approach, it is important to use a highly accurate quantitative test to measure antibodies to the viral protein used in the vaccine to understand the level of protection. In addition, tests need to move to being standardized and measured on the same scale, like the World Health Organization’s standard for SARS-CoV-2 immunoglobulin, to ensure they’re compatible across tests, regions and studies. Otherwise, the data means little because it is not measured on the same “ruler.”

When public policy moves from a single population health approach to appreciating our individual health differences, aided by the right diagnostics, we’ll be more effective to move toward an end to the pandemic.

  1. Not many companies have the experience that Ortho Clinical Diagnostics has. You have been transforming in vitro diagnostics (IVD) for more than 80 years. With over 130 countries served and 40 distribution centers, can you tell us about the team and leadership that help make the operation run so well?

When you think about where we contribute to health care, our brand promise — our focus — is Because Every Test Is A Life.™Our dedicated teams know that every specimen on our instruments is so much more than that — it’s somebody’s life. 

We never forget how high the stakes are, which is why we work every day to deliver accurate test results, easy-to-use technology and continuous collaboration to ensure our customers achieve the most important measure of success — exceptional patient care. 

Our senior executives comprise individuals who have significant executive leadership experience across the diagnostics, life sciences and health care industries. Their diverse backgrounds bring unique perspectives to Ortho, helping drive performance and ensuring exceptional customer service.

For all our teammates, it is about more than diagnostics — it’s about making an impact on people’s lives, and that’s really what drives us. 

  1. What is next, in the future, pipeline, etc.?

When we look at health care in general, we do it with an eye on operational financial impacts as well. We know there’s pressure on reducing costs in health care, and we believe that our instruments, which are not just our tests but the analyzers we use, are all geared to deliver the lowest total cost of ownership for our target markets. Our customers can do business with Ortho and know they’re getting the best quality results and a solution that fits financially.

As I mentioned above, the use of highly accurate quantitative antibody tests will continue to be needed as vaccine and booster programs roll out and health care teams take a more personalized approach to delivering lifestyle guidance for at-risk populations and children. 

  1. Where do you see the company in the next five years?

In the next five years, I anticipate continued growth in geography and pipeline while delivering on customer needs to help them provide exceptional patient care.

We have a great responsibility as well as a great opportunity to advance innovation in the field, reduce health care costs and reinforce our high standards for customer service and value. 

We will expand our global footprint, including growing in emerging markets and further penetrating the mid- to high-throughput labs that would benefit from greater use of our in vitro diagnostics. Establishing shared service centers in different geographies and time zones around the world allows us to innovate faster. It also positions service and support teammates closer to our current and potential customers. 

Protecting the environment and advancing sustainability go hand in hand with our mission to improve and save lives with diagnostics, so we will continue to incorporate environmentally responsible practices into our products, manufacturing, packaging and supply chain. 

Finally, we will maintain our continuous focus on speed of test results so customers can deliver the highest quality test results to the clinicians who determine treatments.

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