Invigorated by next-generation sequencing (NGS) and other advanced testing technologies, laboratory testing services have surged from obscurity to a leading market strategy for new clinical diagnostics. The $100 billion-plus clinical lab services market features strong demand in the United States for laboratory developed tests (LDTs). These advanced testing services allow labs and diagnostic manufacturers to bring tests to market without FDA approval and have been crucial to the development of clinical sequencing markets for oncology and non-invasive prenatal testing (NIPT).