Check out the New Clinical Flow Cytometry Wiki There are lots of interesting cases, useful resources, and an opportunity for YOU to contribute and make it even better. Clinical Flow Cytometry Wiki
The Caribbean Cytometry & Analytical Society (CCAS) has opened their official society website. Click here to visit the CCAS site.
The 21st Annual International Clinical Flow & Image Cytometry Course will be held at Roswell Park Cancer Institute from Aug 30 - Sept 4, 2009. Please click here for more details.
The 5th European Course on Clinical Cytometry and the 9th Euroconference on Clinical Cell Analysis will be held on8-12 September 2009 in Saint- Etienne, France. Click here to visit the ESCCA site.
CLIA Manual Available for Free!
Representatives from CCS and ISAC have been working on an updated Flow Cytometry CLIA Compliance Manual for members of the two societies. There are extensive changes, particularly in the area of Quality Assessment, and this document should prove useful to flow cytometry laboratories. At the most recent CCS and ISAC council meeting, there was unanimous agreement that this document should be made freely available to registered members of CCS and/or ISAC. After logging into CCS as a member you can access the document from the member services page.
ANNOUNCEMENT:
After the regulatory affairs session at the last meeting there was some confusion about the new FDA guidance document regarding the production of antibody"cocktails". Specifically, it was not clear to many whether the sentiments in that document applied to individual laboratories making their own cocktails of ASRs purchased from manufacturers. I had a discussion with Dr. Steven Gutman, director of the in vitro diagnostics device division at FDA, and he clarified the situation and approved the following statement: There is no intent for the FDA position to apply to individual laboratories, or to prevent them from making cocktails; laboratories have the responsibility to validate the use of ASRs as components of laboratory assays, but they are free to do this validation using either individual ASRs or cocktails that they themselves assemble, depending upon their laboratory practice. There is no requirement that a laboratory making such cocktails submit any documentation on their performance to the FDA.
At the same time, he made it clear that manufacturers WILL have responsibility for FDA submissions if they are going to continue to market antibody combinations. We are exploring ways in which CCS can help manufacturers with these submissions.
Representatives from CCS and ISAC have been working on an updated Flow Cytometry CLIA Compliance Manual for members of the two societies. There are extensive changes, particularly in the area of Quality Assessment, and this document should prove useful to flow cytometry laboratories. At the most recent CCS and ISAC council meeting, there was unanimous agreement that this document should be made freely available to registered members of CCS and/or ISAC. After logging into CCS as a member you can access the document from the member services page.
Society Journal