Nicole Tolan, Ph.D.

Nicole Tolan headshot

My clinical-translational research and clinical service expertise involves the implementation of new, novel technologies and critical and point-of care testing applications in the clinical diagnostics laboratory; with an emphasis on quality improvement to advance standard practice and improve patient outcomes. I am recognized for my work with critical and point-of-care testing, validation of new assays, and as a proponent of assay standardization.

I have mass spectrometry industry experience, primarily focusing on clinical-translational research and improving diagnostic testing through innovative technologies and novel assay designs. I held a leadership role in the oversight of FDA-cleared/exempt in vitro diagnostic (IVD) assay submissions, hardware and software components of medical device instruments, and research use only (RUO) reagents.

 I have experience leading strategic planning and roadmapping for product development and also providing consultation as to the medical significance of testing and requirements for clinical diagnostic products.

I am active in a number of professional societies, namely the American Association for Clinical Chemistry (AACC) Society of Young Clinical Laboratorians (SYCL) and the College of American Pathologists (CAP) Instrumentation Resource Committee. I’ve committed much of my time to education, providing mentorship through the AACC SYCL Mentorship Programs and SYCL 360, as well as, teaching medical residents and providing continuing education at local section and annual scientific meetings.