The Association for Diagnostics & Laboratory Medicine (ADLM) has published the first comprehensive US guidance designed specifically to help laboratory medicine professionals provide diagnostic services for gender-diverse patients. The document addresses challenges that arise when interpreting laboratory test results in people receiving gender-affirming hormone therapy and outlines practical recommendations for pathology and laboratory practice.
The guidance responds to a growing need as more patients receive gender-affirming care. Hormone therapy can alter the results of routine laboratory tests, including assays used to evaluate kidney, liver, and cardiovascular health. These physiological changes can complicate the interpretation of results if traditional reference intervals are applied without considering an individual's hormone status and clinical context. Rather than relying on a single reporting framework, the guidance recommends a more personalized approach to diagnostic interpretation that incorporates physiology, hormone exposure, and the patient's overall clinical presentation.
Beyond test interpretation, the document highlights changes that could strengthen laboratory-supported clinical care. It recommends incorporating organ inventories into electronic health records so that laboratory findings can be interpreted alongside relevant anatomy and appropriate preventive screening decisions. The guidance also calls for more standardized approaches in transfusion medicine involving transgender and nonbinary donors and recipients, and recommends pathology practices that document both legal sex and affirmed gender identity while using anatomically accurate, gender-neutral terminology.
The recommendations primarily apply to adults who have received gender-affirming hormone therapy for at least six months, reflecting the area with the strongest available evidence. ADLM notes that the evidence base is still developing, but the guidance provides laboratories with an initial framework for adapting diagnostic workflows as knowledge evolves.
ADLM President Paul J. Jannetto says, “For too long, laboratory medicine has lacked clear guidance for meeting the needs of gender-diverse patients, leaving laboratory and other healthcare professionals to navigate critical decisions without a consistent framework. ADLM’s recommendations help close that gap by giving laboratories the tools to interpret test results more accurately, document essential patient information, and support more personalized care. Ultimately, this guidance has the potential to reduce confusion, improve clinical decision-making, and ensure that gender-diverse patients receive the respectful, equitable care they deserve at every stage of life and in death as well.”
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