B-371 Significant opportunities for US clinical labs to enhance guideline adherent Multiple Myeloma (MM) diagnostic testing

Abstract Background Multiple Myeloma (MM) is among the cancers having the longest delay from first symptoms to diagnosis. Patients often initially present to their primary care providers (PCPs) and may visit multiple times before being referred to a specialist. Laboratory testing is pivotal in the diagnostic workup, especially in primary care settings where initial investigations often occur. The College of American Pathologists (CAP) has published guidelines for the laboratory detection and initial diagnosis of monoclonal gammopathies in 2022. Timely diagnosis has been proven to result in fewer complications and improved patient outcomes. This study by the Binding Site, part of Thermo Fisher Scientific, assessed the awareness of recommended MM diagnostic workup as well as the current approach to MM diagnosis among US PCPs to identify opportunities for improving laboratory test ordering practices for improved patient care. Methods A quantitative survey was designed by the Binding Site and fielded by Bioinformatics, LLC between October to December 2024. Responses were received from 300 US PCPs, comprising 276 physicians and 24 nurse practitioners/physician assistants from specialties including Family Practice (50%), Internal Medicine (43%), General Practice (6%), and Geriatric Medicine (1%). The survey assessed PCPs’ understanding of guideline-adherent MM diagnostic testing, including awareness of specific diagnostic tests and reliance on laboratory services. Key metrics assessed through the survey included the utilization of serum protein electrophoresis (SPEP) and serum Free Light Chain (sFLC) co-testing, adherence to plasma cell dyscrasia diagnostic testing guidelines, access to predefined MM diagnostic panels and awareness of common MM symptoms. Results While all surveyed PCPs would order SPEP when suspecting a plasma cell disorder, only 71% (n=212) would consider ordering sFLC. However, just 40% (n=84) order sFLC alongside SPEP, despite their combined use being recommended in CAP guidelines for accurate diagnosis, highlighting a significant gap between professional guidelines and actual clinical practice among US PCPs. Only 21% have access to predefined order sets/test panels, though 54% would prefer using them if were available. Among the test panels offered by labs to the surveyed PCPs (n=77), SPEP, sFLC, and immunofixation electrophoresis (IFE) were included in 84%, 60%, and 49% of the current panels, respectively, indicating the inadequacy of currently offered panels. Only about 20% of respondents were extremely confident in knowing which tests to order and how to interpret results. Most surveyed PCPs said they must rely on their peers and hematologists for the interpretation of the results. Conclusion The study reveals significant gaps in the understanding and practice of MM diagnostic testing in primary care. Results imply insufficient knowledge and inadequate utilization of testing guidelines, including low confidence in test ordering and interpretation of test results. Our survey also suggests the lack of comprehensive, uniform and guideline-adherent MM diagnostic panels offered by US laboratories. Insights from this survey warrant a focus on the development and dissemination of comprehensive laboratory diagnostic panels and interpretation tools tailored to the needs of PCPs. Improvement of laboratory service strategies in this field could lead to improved patient outcomes in MM and related plasma cell disorders.