This RFQ replaces any previous RFQ posted relating to this requirement. Please, respond per attached RFQ posted on SAM.gov. Interested vendor should follow the RFQ instructions and submit a quote accordingly, by the due date. No reminders will be provided, nor will FDA accept late quotes. Also not the following feedback from industry.
Note****. Our major issue is shipping out slides especially since many of the biopsies might have limited material. Would you be willing to receive Whole-slide images; we use the Aperio GT450 as our standard workhorse scanner; and could provide scanned images (and primary and secondary metadata).
Response:[BDG:] Slides are shipped all the time in pathology. If you have limited material on the slides, there will be limited material on the images. We don’t feel you have described a legitimate issue. Furthermore, the Aperio GT450 is not an FDA cleared device, and the images would have limited value in a validation data set to be used for regulatory purposes. We will consider this offer in comparison to other offers.
RFQ does not have any follow-up clinical data? Would that be of any interest?
Response: [BDG:] No. We have identified the metadata that we want, and it does not include follow-up clinical outcomes.