Quest Diagnostics is emphasizing the critical role of in vitro diagnostics (IVDs) in shaping modern healthcare and advancing precision medicine, according to Dr. Neelam Dhiman, director of science for molecular infectious diseases at Quest.
IVDs, defined by the Food and Drug Administration as reagents, instruments and test systems used to diagnose disease, influence about 70% of healthcare decisions. These tests range from laboratory-based diagnostics to point-of-care and direct-to-consumer options, covering conditions from infectious diseases to oncology.
“Diagnostics provide health systems with essential information to help manage diseases,” Dhiman said during a recent interview. She noted that approximately 40,000 IVD products are available today. IVDs are central to precision medicine, enabling identification of patients who may benefit from specific treatments. Advanced tools such as next-generation sequencing analyze genetic variants to tailor care. Companion diagnostics, a subset of IVDs, guide safe and effective use of targeted therapies by identifying patients likely to respond, assessing risk of side effects and monitoring treatment response.
Developing these tests requires rigorous validation and regulatory approval, often involving partnerships between manufacturers and central laboratories. Dhiman said Quest Diagnostics national footprint, extensive biorepository and infrastructure make it a leading partner for IVD manufacturers. The company processes up to 150 million patient data points annually and offers more than 3,500 assays. Quest Diagnostics provides space for large instruments, access to predicate devices, and dedicated staffing for clinical trials. Its CLIA-, CAP- and ISO-certified labs support FDA submissions, ensuring quality and compliance.
“Our motto is on budget, on time and on quality,” Dhiman said, underscoring Quest Diagnostics commitment to efficient, high-quality trial execution.
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