I don't know if anyone else found the following details on the...

I don't know if anyone else found the following details on the new MRD test.  Here is the link.

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM402062.pdf

Heavy reading but worth it. It appears that if PAT-SM6 performs in the upcoming trials approval could be around the corner.

Independent of the preferred methodological platform(s) for evaluation of response to treatment, based on the success of newer drugs it seems reasonable to argue that with more active agents becoming available, there is emerging need to assess not just if complete response has occurred, but the exact magnitude of response and if there is any evidence of MRD. Given that virtually every study focusing on MRD testing in myeloma has reported MRD negativity (vs MRD positivity) to be associated with better progression-free survival, and some studies have found MRD negativity to be associated with better overall survival, it seems logical to propose that MRD testing needs to be integrated in future uniform response criteria for multiple myeloma, and, consequently, should be considered for regulatory purposes including drug approval in the field of multiple myeloma. In order to facilitate this process, there is urgent need for consensus criteria for MRD negativity in myeloma.


But the FDA raises important issues about using MRD as a clinical endpoint.

"For minimal residual disease (MRD) to be used as a surrogate endpoint, there must be a clear understanding of the disease process, and the effect of the intervention on both the clinical benefit endpoint and the biomarker. It is important to understand if there is a difference in the effect on the biomarker with different interventions and if there are other factors involved which may diminish the correlation of the biomarker and the clinical benefit endpoint. Also, standardization of the definition and assessment methods for MRD is necessary for wider implementation, generalizability, and interpretation of the results generated."

There is a lot going on in the background with Patrys which they are not telling us about and I get the feeling the moves been made hint that PAT-SM6 is very valuable to someone.

The cat must be getting restless.