Germline PGx Molecular testing

Background: The Department of Veterans Affairs (VA) National Oncology Program is issuing this RFI in accordance with FAR 15.201(e). The agency does not intend to award a contract but rather gather information on capability, delivery, and other market information pertinent for acquisition planning. The result of this market research will contribute to determining the method of procurement and identify parties having an interest in and the resources to support this requirement.

Summary of Key Deliverables: Molecular Testing Requirements applicable to:

Germline Genetic Testing Mandatory methodologies: DNA-based testing such as multi-gene panels, whole exome sequencing, whole genome sequencing, single gene assays, and single allele assays using next generation (massively parallel) sequencing Sanger sequencing, or other methodologies with a description of platform each test is run on (Ex: genome or exome backbone). Provide at least 75% of preferred tests as described in (Attachment A -Key Deliverables) and Germline Genetics Price Schedule.

Gene lists for panels must comply with required genes according to ACMG, ESMO and other published standards for germline genetic testing. Preferred genes within panels are indicated in the Germline Genetics Price Schedule. The proposal must include reference to how well contractor gene lists overlap with those described in the Schedule. See Attachment C (Test Offerings) Pharmacogenomics Molecular Testing Offer appropriate testing methodologies specific to pharmacogenomics needs.

Molecular analyses including DNA-based tests such as next generation sequencing (NGS) for the mandatory genes and genetic variants described above any preferred gene panels listed above. See Attachment C (Test Offerings) All Molecular Testing Offer ordering provider created custom gene panels (ability to add/subtract genes from already curated panels) at no additional cost. Have the ability to reflex to a larger panel of genes associated with phenotype at no additional cost when no additional specimen is needed.

Offer STAT testing with expedited turnaround times when needed. Provide site specific mutation testing utilizing a previous family member’s test. Provide evidence of current CAP/CLIA accreditation with certificates. Offer testing and interpretation on site or at wholly own subsidiaries.