Medical Devices

Public Workshop - In Vitro Diagnostic Testing for Direct Oral Anticoagulants, October 26, 2015

The Food and Drug Administration (FDA) is announced a public workshop entitled “In Vitro Diagnostic Testing for Direct Oral Anticoagulants”. The objective of the workshop was to discuss analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs), and the clinical circumstances under which patients receiving these agents would require testing. Specifically, this workshop aimed to 1) evaluate the impact of DOACs on traditional coagulation testing results; 2) identify clinical circumstances where testing of DOACs anticoagulant activity or concentration would be relevant; 3) discuss clinically meaningful interpretation of coagulation testing results for patients on DOACs; and 4) review the regulatory requirements for granting clearance for in vitro diagnostic devices intended for coagulation testing in patients treated with DOACs.


Date, Time and Location

This meeting was held October 26, 2015, beginning at 9:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

The meeting was webcast.

Webcast Archive

Transcript

Agenda

AM Session
TimeEventSpeaker
9:00–9:10amIntroduction and WelcomeLeonthena Carrington, FDA/CDRH
Laboratory and Clinical Perspectives
9:10am–9:30amOverview of DOACs and their clinical indicationsRobert Califf, FDA
9:30–9:50amChallenging Cases Involving Emergency Department Patients on Novel Oral AnticoagulantsFrederick Korley, Johns Hopkins
9:50–10:00amMeasurement of the DOACs: Basic Principles and Attributes of an Ideal AssayAdam Cuker, University of Pennsylvania
10:00–10:20amMethods for measuring Direct Oral AnticoagulantsDorothy Adcock-Funk, Colorado Coagulation
10:20–10:40amThe clinical laboratory establishing and offering a DOAC measurement test: What's important? Robert Gosselin, University of California, Davis
10:40–10:50amQuestions for speakers 
10:50–11:10amBreak
11:10–11:30amWhen are tests for DOAC measurement clinically needed and how to interpret and use the resultsStephan Moll, University of North Carolina, Chapel Hill
11:30–11:40amMeasurement of the DOACs: Suggestions and Guidance StatementsAdam Cuker, University of Pennsylvania
11:40am–12:00pmNew Oral Anticoagulants Pharmocokinetics, Pharmacodynamics, and Exposure-ResponseMartin Rose and Jeffry Florian, FDA/CDER
12:00–12:10pmQuestions for speakers 
12:10–1:00pmLunch

PM Session

TimeEventSpeaker
Commercial Development
1:00–1:20pmIn Vitro Diagnostic Testing for Direct Oral AnticoagulantsBryan Laulicht, Perosphere
1:20–1:40pmDevelopment of Assays for the Testing of Direct Oral AnticoagulantsMark Triscott, Instrumentation Laboratory
1:40–2:00pmDOAC Detection on TEG®6sMarc Doubleday, Haemonetics
2:00–2:20pmTesting for Direct Oral Anticoagulants-An IVD Perspective Francois Depasse, Daniel Kaczor, Stago
2:20–2:30pmQuestions for speakers 
2:30–2:50pmBreak
FDA Perspective
2:50–3:10pmTest Outputs and InterpretationMarina Kondratovich, FDA/CDRH
3:30–3:50pmRegulatory ConsiderationsAbraham Tzou, FDA/CDRH
3:50–4:00pmQuestions 
4:00–4:30pmPanel Discussion 
4:30–4:45pmMeeting Wrap-Up and Adjourn  Leonthena Carrington, FDA/CDRH

Contact Us

For questions regarding workshop content please contact:

Claudia Dollins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5554, Silver Spring MD 20993, 301-796-4807, email: Claudia.dollins@fda.hhs.gov

Page Last Updated: 12/16/2015
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