Black Swan, Salamanca, and the FDA: Debut of a Highly Sensitive New MRD Test
March 26, 2014
A significant event in the evolution of the IMF's Black Swan Research Initiative occurred this past weekend in Salamanca, Spain. On March 21-22, the IMF-EuroFlow Workshop - co-organized by Lisa Paik (Senior Vice President of Clinical Education and Research Initiatives at the IMF) and the Salamanca-based flow cytometry team - focused on a breakthrough in the standardized detection of minimal residual disease (MRD) in myeloma.
This new technique is an automated and highly sensitive flow cytometry for the standardized detection of minimal residual disease (MRD) in multiple myeloma. Excited to learn about the latest advance in this method, approximately 70 participants from 13 different countries attended the workshop. There, they learned in a "hands-on" fashion the full details of the new myeloma detection antibody panel and the computer software, which provides results in a standardized automated fashion: identifying each single cell (myeloma or not) in the bone marrow and/or blood samples.
I am thrilled to report that the workshop was a success! Attendees left ready and enthusiastic to introduce the new methods in their home laboratories. Professor Alberto Orfao (Head of the Flow Team in Salamanca) and Professor Jacques van Dongen (his colleague from the EuroFlow team at Erasmus in Amsterdam) did a fantastic job in constructing and implementing an intense and detailed program that more than fulfilled the educational needs of the attendees.
From there, Dr. Bruno Paiva (a key Black Swan investigator from Pamplona in Spain and expert at analyzing patient outcomes) and I traveled directly to the FDA in Silver Spring, Maryland to participate in the FDA-NCI Roundtable: "Symposium on Flow Cytometry Based on the Detection of Minimal Residual Disease in Multiple Myeloma." The bottom line for this roundtable was also tremendously helpful and important for the Black Swan Research Initiative. There is a strong consensus evolving that MRD assessment is both required and recommended for response assessment in clinical trials, and that the new flow methodology is the most promising current approach.
Thus, MRD testing is becoming mainstream and flow is the method of choice. So the Black Swan Research Initiative is definitely "going with flow" right now and we have high expectations that new trials including MRD assessment will lead to better outcomes for all myeloma patients.
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