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Why disruptive innovations matter in laboratory diagnostics.

In the modern era, advances in clinical laboratory screening and diagnostic tests have had a profound impact in improving the quality and value of medical care (1, 2). Today, laboratory diagnostic tests can inform physicians and patients of the exact causes of a number of diseases and disorders, including cancer, chronic diseases, infectious diseases, sexually transmitted diseases, and genetic disorders. This precise ability to identify the nature of illnesses has led to developments of drugs and therapeutic methods that have saved millions of lives (3). Some diagnostic tests, such as those for glycated hemoglobin (type 2 diabetes) and BRCA1/2 (breast and ovarian cancers), are used for early diagnosis of at-risk patients, potentially preventing the onset of costly and deadly cancers and chronic diseases. Laboratory diagnostic tests have always served as the trailblazers of medical innovations by creating new pathways to identify and conquer difficult medical conditions.

Despite this impressive history of evolving diagnostic technologies that reshape and broaden our understanding of diseases, new challenges await us as we look ahead into the 21st century. Difficult-to-treat disorders such as Alzheimer disease, amyotrophic lateral sclerosis (Lou Gehrig disease), lupus, and multiple sclerosis are not well enough understood to be properly diagnosed and classified. Some chronically debilitating and deadly diseases such as cancers, migraines, and Parkinson disease can be diagnosed, but further research is needed to introduce better classification schemes, better preventive screening tests, and more quantitative tests that can effectively track disease progression.

Another challenge facing the clinical diagnostics community is the rising cost of health care. With U.S. direct health care expenses soon to reach …