RFQ Questions and Answers.pdf

1. Can you please share details of requirements for WHISE Grant?

Full details of the grant are not pertinent. The grant highlighted a need to obtain an FDA cleared HPV assay with self-collect.

2. There is very little detail in the SOW around specifics of the HPV Assay itself. With the ultimate goal of the highest patient care standards for our female veterans, have you taken into account the following?

This procurement is for a molecular instrument that has the ability to perform HPV testing with FDA clearance for self-collect. Market research has been performed on the various assays on the market and the government is comfortable with the HPV assay performances that are FDA cleared with self-collection.

a. ASCCP Management Guidelines have recently changed, specifying treatment guidelines based on certain high risk individual genotypes as well as pooled genotypes. BD Onclarity most closely aligns with these new guidelines with the most comprehensive results for both individual genotype results and intentionally pooled results. For example, there is specific guidance around pooled results for genotypes 56, 59, and 66 in these guidelines. BD’s Onclarity HPV assay intentionally provides these results together. Have you considered that other assays do not align with these new guidelines?

i. Resource Link: Journal of Lower Genital Tract Disease

b. With the advent of HPV Patient Self Collection, there are major differences in how specimens are collected, stored, and transported to the laboratory for testing. Most significantly - BD’s collection swab remains in the tube for transport to the lab, whereas other assay collection devices must be use a “swish and swirl” method where the collection device is discarded, resulting in a potential loss of specimen quality and quantity

i. Resource: See attached comparison of self-collected samples from BD and

Roche.

3. From section 2.17: Can you please specify why there is a need for 3 aliquots from a single specimen? Is this needed for testing outside of HPV testing? Is it needed to address high indeterminate rates?

This is a procurement for molecular instrumentation that needs to meet requirements as outlined above in WHISE Grant and laboratory testing needs.

4. From section 2.18: Is this grant is for FDA cleared testing, why is Open Channel capability a requirement?

This is a procurement for molecular instrumentation that needs to meet requirements as outlined

5. From Section 2.19: If this grant is for HPV testing only, why are is there a requirement to run 4 different tests simultaneously?

This is a procurement for molecular instrumentation that needs to meet requirements as outlined https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Furldefense.com%2Fv3%2F__https%3A%2Fjournals.lww.com%2Fjlgtd%2Fpages%2Farticleviewer.aspx%3Fyear%3D2025%26issue%3D04000%26article%3D00005%26type%3DFulltext__%3B!!HLrAl2XzZ3iCLg!GTIo-JuS9tjDL9PKM9GyDrST-iXKn5-onbqoIdES25s8JkeM18mmFM4IGCdXuBn5BvdUt7cQcCgUWRLbspL7ts3p4nJJqP8%24&data=05%7C02%7C%7C6583133346f04a9beb9f08dd713958ba%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638791213294047540%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2Fz7rEmb2vWk%2BykR%2Br6CrbI388bMuMH0LfJ642somL9M%3D&reserved=0

6. From section 2.3.1: Instrument Footprint: Does the 60 x 80 x 48 inch footprint take into account mandatory clearance on the sides of the instrument?

Yes, it does consider clearance.

7. Are all 8 sites able to accommodate the size (including needed clearance) specified in the SOW, or would multiple instrument size options (that run the same Onclarity HPV Assay) be an advantage considering the varying space constraints for the individual laboratories?

Space is an issue at all of our laboratories. A small footprint is needed to ensure laboratory operations are not affected.