Changes in the diagnostics industry demand agility, innovation

A friend recently took one of the popular swab-your-cheek, at-home ancestry tests and, knowing that I’ve spent my career in the diagnostics industry, asked for my perspective on these tests.

I’m all for them. Not just because they can give us an interesting view into our history and health, but because I hope they will spark an even greater interest in what’s involved in any diagnostic test. I believe that this growing trend of at-home, non-disease-oriented, consumer-performed testing will lead to better dialogue about and understanding of the more traditional disease-oriented diagnostic tests that underpin the entire health care ecosystem.

The trend toward patients becoming more comfortable asking for and controlling their own health information is driven by home-based tests and by lab portals where you can retrieve your test results, and also by the broader shift of patients becoming more in tune with their own health needs. The rapid cycles of innovation that consumers are seeing in every industry they touch, from high-tech to retail, transportation, travel, and entertainment, are empowering people to ask for — and expect — fast, meaningful answers to questions about their health. If you can order a ride across town or that movie your colleague recommended with just a swipe and a tap of your finger, why should you have to wait for your lab results?

I work in the industry known as in vitro diagnostics, which literally translates to diagnosis “in glass,” meaning equipment like test tubes and beakers. We have come a long way since the days when lab techs would shake fluids in test tubes and hold them up to the light to wait for a reaction. Today’s in vitro diagnostics are sophisticated, automated, and integrated.

It’s an intensely rigorous field that is often overlooked by the institutions it serves and by patients awaiting diagnosis and treatment. Diagnostic tests influence 66 percent of clinical decisions, yet the in vitro diagnostics industry accounts for only 2.3 percent of US health care spending. Even that fraction is under threat, as competing parts of the health care continuum grapple for funds in the face of increasing complexity and heightened standards in health care.

There are stark differences between what consumer-focused companies, such as those that show your genetic health profile or tell the story of your ancestry, and what traditional in vitro diagnostics companies are doing. Those of us developing tests and analyzer platforms for clinical labs and blood banks are driven by the need for precision and reliability. The work done in the lab informs life-and-death diagnosis and treatment decisions. Diagnostic tests can identify critical problems such as kidney failure, heart attacks, and HIV infection in time for meaningful treatments to take effect, or quickly match blood so patients get the right blood for their type.

High-stakes diagnostics are undertaken against a backdrop of increasing pressure on the lab. According to the National Accrediting Agency for Clinical Laboratory Science, the nation’s labs need to fill more than 7,000 jobs annually. Yet US clinical laboratory education programs produce only about 6,000 qualified professionals each year. In addition, the average lab technician is in his or her late 40s to early 50s and starting to think about retirement. The shortage of laboratory technologists is a real and growing challenge for today’s labs.

What’s the industry’s response to these challenges? The right one: innovation. Innovation in the in vitro diagnostics field is qualitatively different from the open-ended innovation being performed in other fields, because of the need for precision and accuracy.

While innovation in diagnostics always works toward a set endpoint — the correct result — it continues to become broader and more creative. The days of focusing only on developing new assays are gone. The industry now employs a corps of engineers and software developers who help us build complex, scalable, automated analyzers that efficiently perform ever more sophisticated tests. And we work with optics experts who help us deliver visual information in a way that resonates with newer generations of lab techs. The race in this industry is becoming less a marathon and more of a decathlon; successful companies need to perform well on many previously disparate types of work.

Personalized medicine is a clear example of where in vitro diagnostics is headed. The fast-growing core personalized medicine market will be worth more than $149 billion by 2020. The concept here is that a patient’s unique genetic and biological makeup is used to inform and tailor his or her treatment. Immunotherapy cancer protocols, for example, can be stunningly successful, but may work for only certain individuals. Identifying those individuals quickly is essential, requiring that diagnostic techniques become more specific, more sensitive and more precise in order to elucidate the exact nature of a patient’s condition with a high degree of certainty.

The notion that medical advances drive innovation in diagnostics is true in blood matching, as well. People with diseases that require frequent blood transfusions, such as sickle cell disease, are living longer than ever before. This tremendous success brings with it a previously rare complication: alloimmunity. This is an immune reaction to various elements of the blood, triggered by repeated exposure to transfused blood. In these situations, immunohematology — the science of blood matching — will have to go far beyond distinguishing between A, B, and O blood types to find a match on more than a dozen elements order to ensure a safe transfusion.

The industry is also rapidly developing innovative immunoassays that diagnose diseases faster, giving clinicians more time to intervene with new and effective therapies that can change the course of disease.

It’s a fascinating time in diagnostics. My friend waits for test results that will tell her about her ancestry, perhaps revealing new insights into her family and even her health history. While in vitro diagnostics may never grab consumer attention in the same way, we are reimagining what is possible in the lab. When my friend next visits her doctor looking for answers about a health problem, we will be there behind the scenes, delivering the precise, accurate answers that drive medical decision-making today.

Martin Madaus is the chairman and CEO of Ortho Clinical Diagnostics, a global in vitro diagnostics company headquartered in Raritan, N.J.