Validated biomarkers are an essential and often under-appreciated tool for detecting and treating diseases, improving drug development, and informing regulatory decision making. Recent advances in genetic and molecular technologies are leading to the identification of sensitive, specific, and validated biomarkers for numerous diseases, including multiple sclerosis, pancreatic cancer, Alzheimer's disease, and more. Development of biomarkers that rely on digital technologies are of great interest to many stakeholders. What is new and promising in this realm of critical tools for the biomedical innovation ecosystem? Are issues of access to these tools by physicians and patients being addressed?