Ortho Clinical Diagnostics: global partner for clinical labs, transfusion medicine

Nov. 20, 2015

If you were explaining Ortho Clinical Diagnostics to someone who is not familiar with the organization, how would you characterize its areas of expertise? Ortho Clinical Diagnostics is a global in vitro diagnostics leader serving the global clinical laboratory and transfusion medicine communities. Worldwide, across hospitals, hospital networks, blood banks, and commercial and specialty labs, our high-quality products and services enable healthcare professionals to make better medical decisions to improve and save lives.

For more than 75 years, Ortho Clinical Diagnostics has pioneered some of the most important, life-impacting advances in diagnostics. These advances range from early work in blood typing to the latest developments in laboratory systems.

Martin Madaus, Chairman and CEO Ortho Clinical Diagnostics

“I became Chairman and Chief Executive Officer of Ortho Clinical Diagnostics when it became an independent company in June, 2014. Prior to joining Ortho Clinical Diagnostics, I most recently served on the Board for Quanterix, and was the Chairman, President, and CEO of Millipore prior to it being acquired by Merck.”

I hold a doctor of veterinary medicine degree from the University of Munich, Germany and a PhD in veterinary medicine from the Veterinary School of Hanover, Germany.

I enjoy outdoor activities such as kite surfing, running, and hiking. I also support multiple nonprofit groups, including Project Hope (Health Opportunities for People Everywhere), a group committed to providing lasting solutions to health problems and helping people to help themselves.

To the global transfusion medicine community, we bring donor screening, as well as blood typing products, to help ensure every patient receives blood that is safe, the right type, and the right unit. Around the world, we bring sophisticated testing technologies, automation, information management, and interpretation tools to clinical laboratories to help them run more efficiently and effectively and improve patient care.

Worldwide, Ortho Clinical Diagnostics is a team of diverse, best-in-class talent, united by a shared mission: to help healthcare professionals around the world make better medical decisions with diagnostics.

What major categories of solutions does the company provide for its customers? Customers turn to Ortho Clinical Diagnostics for the innovative technologies, products, services and solutions that help them get accurate test results and also optimize the operations within the lab.

Clinical laboratories appreciate that our core technologies provide reliable, timely, and accurate information. These innovations include our patented dry-slide chemistry, enhanced chemiluminescence for immunoassay testing, and highly advanced laboratory automation. We are continuing to press the boundaries of what’s possible in our quest for new and better assays.

Our leadership in Transfusion Medicine centers on our commitment to patients—we want to make sure that every patient receives blood that is safe, the right type, and the right unit. We do this through responsive automation—our transformational approach to immunohematology testing—with our instrumentation and reagents for blood typing and infectious disease screening.

The company recently received FDA 510(k) clearance for its VITROS Chemistry Products HbA1c Reagent Kit. What benefits will this product have for customers? We are very excited about the recent clearance of the VITROS Chemistry Products HbA1c Reagent Kit. The assay was developed for improved accuracy to meet the recently tightened National Glycohemoglobin Standardization Program (NGSP) certification requirements, as well as to meet the evolving needs of today’s laboratory professionals. It offers operational and performance enhancements that include higher throughput and simplified calibration. Plus, it is easier to use and faster than our earlier assay to enable customers to effectively, productively, and confidently diagnose and monitor diabetes in patients. The VITROS Chemistry Products HbA1c Reagent Kit can be used in patients with hemoglobin variants S, C, D, and E traits without concerns that common hemoglobin variants will interfere with results.

The VITROS Chemistry Products HbA1c Reagent Kit is the latest advancement in a series of laboratory systems Ortho Clinical Diagnostics has pioneered, beginning in 1978. Since then, the VITROS series has expanded and evolved to include more than 125 assays that offer all of the most important clinical chemistry tests, covering major disease states including cardiac disease, cancer, reproductive endocrine disease, infectious disease, thyroid disease, metabolic conditions, and anemia. 

Late last year, Ortho Clinical Diagnostics introduced the Astute NEPHROCHECK Test System, to assess risk for acute kidney injury (AKI). What does this system add to AKI diagnostics, an area of growing clinical concern? Ortho Clinical Diagnostics is focused on bringing targeted solutions to our customers that address unmet clinical needs and drive improvements to quality care. The NEPHROCHECK Test System is a perfect example. AKI is a common, costly, and potentially fatal complication in hospitalized ICU patients with acute cardiovascular or respiratory compromise. Identifying risk of AKI is paramount because AKI usually lacks signs and symptoms and can potentially result in irreversible kidney damage if recognition is delayed. The NEPHROCHECK Test System is designed to help healthcare providers assess patients at risk of developing moderate or severe AKI within 12 hours of patient assessment. This early recognition window is vital to help manage the risk of acute kidney injury in these at-risk patients.

I think many of our readers may associate the company most with its contributions to transfusion medicine and the blood bank. Can you tell us, for instance, about the value of the ORTHO VISION Analyzer and the ORTHO Workstation? Transfusion Medicine has been an integral part of the Ortho Clinical Diagnostics’ business since 1944, and it continues to be one of our two core business segments. In August of this year, our ORTHO VISION Analyzer became commercially available in the U.S. and Puerto Rico—a version of it had already been available in Europe, Japan, Latin America, Canada, and Australia. This is a fully automated analyzer for transfusion medicine laboratories, enabling labs to address unpredictable demands with confidence, while reducing a lab’s reliance on manual methods.

The ORTHO Workstation is the only integrated 2-in-1 compact system with reliable Ortho ID-MTS Column Agglutination Technology. There are three distinct areas where this product is a “win” for customers. It has a simple to use combined centrifuge and incubator; it uses Ortho ID-MTS Gel Cards that feature proprietary Column Agglutination Technology; and it was designed with the environment in mind. Being considerate of the earth and its resources is a longstanding commitment of Ortho Clinical Diagnostics; we factor sustainability and environmental impact into the design of our products and in our everyday operations.

The company was purchased last year by The Carlyle Group. How will this ownership change affect customers going forward? The acquisition of Ortho Clinical Diagnostics by The Carlyle Group was a very positive change for our clients and for us. We are more committed than ever to enhance the customer experience, and we are investing in the business in a major way to better serve our clients with state-of-the art solutions for modern hospital labs. For example, we have greatly increased the sales and service resources that support our customers in the USA.

Ortho is now developing a range of new chemistry analyzer immunoassays that will be fully automated and allow customers to standardize on the VITROS platform in their labs. Since the acquisition, we have also received FDA clearance on our ORTHO VISION Analyzer and the VITROS Chemistry Products HbA1c Reagent Kit, two new innovations designed to better meet the needs of customers and patients.

We are making scientific progress, as well. At this year’s American Association for Clinical Chemistry meeting, our researchers presented data on five assays under development. These assays address a range of important areas for clinical lab testing including HIV screening, acute kidney injury prevention, and cardiac troponin monitoring for heart attacks. Ortho Clinical Diagnostics is emerging stronger than ever since becoming a standalone company, and we will continuously build on that momentum with further advancements.

What’s it like to be the CEO of an organization with the scope and reach of Ortho Clinical Diagnostics? What over-arching goals do you hope to accomplish? This year, Ortho Clinical Diagnostics celebrated its first anniversary as a standalone in vitro diagnostics company. It was a milestone celebrated across the globe, as we noted the ways the company has grown and evolved as an independent entity. Looking ahead, I expect to see as much change, excitement, and opportunity as we have seen in our first year. We are investing in our future, pursuing new growth opportunities, and expanding our commercial capabilities. We continue to enhance the quality of our products and have a pipeline of new products in development for our Clinical Laboratory business and our Transfusion Medicine business that will better position us for future success. It is an exciting time to be part of Ortho Clinical Diagnostics, and everyone on our team takes ownership and plays a key role in moving the company forward. I feel privileged and proud to lead this great company through its transformation, and I look forward to us delighting our customers as we move to the next phase of our journey and beyond.