SAT-LB024 Imprecision in Biomarker Analysis: Major Hurdle to Detection and Reversal of Disorders of Aging?

Age-related metabolic diseases, such as CVD and diabetes (prediabetes and insulin resistance), are major contributors to morbidity, mortality, and healthcare costs, which are now estimated at over $350 billion per year in direct expenditures (National Assoc. Biomedical Res, 2016). Biomarkers are essential to diagnosis and manage these common diseases. Yet, clinical indicators such as HbA1C, fasting glucose, and insulin vary widely over time when measured at various (CLIA) labs and should not be the sole drivers to diagnose, monitor, or intervene, particularly when using pharmaceuticals. 100 subjects were assessed with FG, insulin, and HbA1C through two reputable labs for each of two sets of lab tests (Draws 1 and 2). The samples were taken from the same blood draw, identical protocol, procedure and shipping. Significant differences were found (p<.05) between all 3 biomarkers at 2 points in time, separated by 4 to 6 months. When comparing deltas between the two time points, there significant differences in absolute values. Moreover, the direction of the delta was inconsistent between labs. In some subjects, the biomarkers in Lab A revealed increases in FG, insulin, and/or HbA1C, while Lab B showed decreases in the same values drawn at precisely the same time and handled identically. The differences documented between two labs were not systematic, and clinically challenging to interpret. Differences in deltas were even more dramatic when using separate labs for Draws 1 and 2. The choice of laboratory significantly impacts diagnosis and interventions, ultimately impairing accurate outcomes and limiting informed decision-making. Laboratory options are typically dictated by variables outside of the physician control, such as insurance coverage, location, and practice policies. These inter-laboratory variations must be taken into consideration when exploring therapeutic management. Lack of biomarker precision highlights the need for a deeper understanding of alternative modalities to monitor patients with disorders of aging, adaptable advances that are synergistic to biomarkers, such as wearable continuous glucose monitors, and education to lead awareness on the part of clinician with respect to choices in partnering their patients. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.