Advocacy Committee
The Advocacy Committee proactively identifies regulatory, reimbursement and practice challenges affecting the International Clinical Cytometry community’s ability to deliver patient care in all geographies.
The Advocacy Committee alerts ICCS and its associated clinical flow cytometry societies to these issues, and invites them in turn to alert The Advocacy Committee similarly.
When possible and appropriate, the Advocacy Committee and ICCS membership will engage with stakeholder groups and agencies in order to provide expert guidance in the area of clinical flow cytometry to thereby ensure patient access to this crucial diagnostic modality.
Interested in joining the Advocacy Committee? Use the link in the right menu to download the application and submit it to info@cytometry.org.
Chair: Sara Monaghan
Members:
Andy Rawstron
Christopher Trindade
Dietrich Werner
Gerald Marti
Friederike Kreisel
Horatiu Olteanu
Mike Borowitz
Mike Linden
PK Wallace
Pranav Dorwal
Stephanie Toney
Thomas Denny
Teri Oldaker
Virginia Litwin
Wolfgang Kern
Source Guidance
CLSI H62 Validation of Assays Performed by Flow Cytometry, 1st edition
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs): DRAFT GUIDANCE
Companion Document Regarding Adverse Event Reporting For LDTs
Past Projects
Response from the ICCS to the Draft LCD for Flow Cytometry DL30692
A draft guidance for cytometers and flow cytometric assays directed at industry and FDA staff was published in October, 2014. As ICCS members are also stakeholders in this document, the Advocacy Committee drafted a comment letter and encouraged members to submit their own letters. A total of 25 comments were received (as per the regulations.gov website) but they haven't been posted publicly. We'll update this notice as information becomes available.