Summary
The Association for Diagnostics and Laboratory Medicine released new guidance discouraging clot-based testing in patients receiving direct oral anticoagulants (DOACs). However, some laboratories, like Cedars-Sinai Medical Center, are reevaluating their lupus anticoagulant testing strategies due to the prevalence of DOAC use. Laboratories are implementing various strategies, such as using DOAC-neutralizing products and incorporating DOAC screening into their algorithms, to address the challenges posed by DOACs in coagulation testing.
January 2026—Coagulation testing on patients who are treated with direct oral anticoagulants was up for discussion when CAP TODAY publisher Bob McGonnagle met online Nov. 20 with eight others to talk about that and about automation, middleware, and viscoelastic testing. Among those participating were Kristi Smock, MD, chair of the CAP Hemostasis and Thrombosis Committee; Oksana Volod, MD, member of the committee; and Andrew Goodwin, MD, former chair of the committee and advisor through 2025 and now a member of the CAP Council on Scientific Affairs.
CAP TODAY’s guide to coagulation analyzers begins here.
The Association for Diagnostics and Laboratory Medicine released new guidance on coagulation testing for patients who are on direct oral anticoagulants. Andrew Goodwin, do you have any comment to make about it or about these drugs?
Andrew Goodwin, MD, professor and interim chair, Department of Pathology and Laboratory Medicine, University of Vermont Larner College of Medicine, and medical director of the thrombosis and hemostasis laboratory, University of Vermont Medical Center: When that class of anticoagulants—direct oral anticoagulants—came out and were approved by the FDA without laboratory methods for measuring the drug, I can understand why, given their predictable pharmacokinetics and dynamics, it wasn’t a focus for the FDA to prioritize having laboratory testing available. Thus while routine monitoring was not required, there were plenty of clinical scenarios in which we needed to measure these anticoagulants.
I’m concerned that as the next generation of anticoagulants is being developed, the anti-XI drugs, we’ll be in the same boat. It’s imperative we get ahead by developing routine, readily available testing so we don’t suffer from the same lack of understanding—laboratories need to have quantitative measurements for new classes of anticoagulants prior to their release.
Dorothy Adcock, chair of the CAP Publications Committee, and Mike Laposata and many other distinguished coagulation pathologists have been working with us extensively to try to help laboratorians get up to speed on this new class of drugs. Oksana Volod, do you have a comment on the new guidance?
Oksana Volod, MD, director of coagulation consultative service and professor of pathology, Cedars-Sinai Medical Center, and professor of pathology, David Geffen School of Medicine at UCLA: It is my understanding that ADLM discourages clot-based testing in patients receiving DOAC therapy. I am currently reevaluating our lupus anticoagulant testing strategy as we work to implement Stago software intended to improve the efficiency and standardization of LA testing.
While working with the team on this project, I reviewed the ISTH [International Society on Thrombosis and Haemostasis] and CLSI [Clinical and Laboratory Standards Institute] guidelines. The ISTH guidelines specifically advise against lupus anticoagulant testing in patients on DOACs. If testing is deemed necessary, it must be clearly stated that the result is based on DOAC removal.
Given these recommendations, I am leaning toward not performing lupus anticoagulant testing on patients actively receiving DOAC therapy. Currently, LA testing accounts for approximately one-third of our ordered tests, suggesting that a substantial proportion of patients being tested are on DOACs. Despite consultative comments, clinicians continue to order LA testing in this setting.