As the President of LDT2FDA LLC, Eric White brings a wealth of expertise in molecular diagnostics and clinical laboratory operations, positioning himself as a pivotal figure in the consulting landscape for CLIA labs. With a strong foundation in next-generation sequencing (NGS) research and development, Eric...
As the President of LDT2FDA LLC, Eric White brings a wealth of expertise in molecular diagnostics and clinical laboratory operations, positioning himself as a pivotal figure in the consulting landscape for CLIA labs. With a strong foundation in next-generation sequencing (NGS) research and development, Eric is adept at guiding laboratories through the intricate regulatory requirements associated with Laboratory Developed Tests (LDTs) and FDA submissions. His extensive experience in clinical assay development and test launch has equipped him with the nuanced understanding necessary to navigate the complexities of CLIA, CAP, and NYCLEP accreditations.
At LDT2FDA, Eric leads a dedicated team focused on providing tailored consulting services that empower CLIA labs to achieve compliance and operational excellence. His hands-on approach ensures that clients not only understand the regulatory landscape but also implement best practices in assay design, validation, and submission processes. Eric's proficiency in biochemistry, biotechnology, and bioinformatics enhances his ability to develop innovative solutions that meet the evolving needs of the diagnostics industry.
Key projects under Eric's leadership include the successful launch of multiple molecular diagnostic assays that have significantly improved patient outcomes. By leveraging his skills in genomics, DNA analysis, and gel electrophoresis, he has been instrumental in advancing the capabilities of clinical labs to deliver accurate and timely testing results. Eric’s commitment to excellence and his strategic insights make him a trusted partner for laboratories seeking to thrive in a competitive and highly regulated environment.