36C24E21Q0062.docx

Contract Opportunity Special Notice

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AN41

Metabolomics 15212-5319 36C24E21Q0062 N 325413 US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319 Contracting Officer Elaine F DiBucci elaine.dibucci@va.gov

(412) 822-3432 The Veterans Administration Palo Alto VA Research and Development Group intends to negotiate on a sole source basis with Metabolon to provide services relating to the analysis of EDTA plasma samples utilizing the DiscoveryHD4TM platform in support of the Million Veteran Program (MVP). Metabolon performed these services for the pilot study and given the unique and limited resource represented by MVP samples, and to maintain consistency in research, a sole source is required. Potential vendors must have the following qualifications, capabilities, and be able to document the following:

a. Headquarters and laboratory facilities where work to be conducted in is located within the Continental United States. No work shall be performed outside of the United States or in any locality outside of the jurisdiction of the laws of the United States.

b. Evidence that the technology to be used works under human plasma derived from whole blood using EDTA as anticoagulant

c. Data that the technology to be deployed covers major biological pathways as evident by bioinformatic reports to support this statement.

d. Evidence that provider has the option to recover further biomarker assays based on original readings

e. Platform to be deployed to include at least 1,000 unique biomarkers

f. Evidence, from publications, that platform to be deployed can identify individuals at high-risk on a wide range of medical entities (i.e., disease agnostic)

g. Provider must demonstrate evidence that have measured >50,000 human samples to date

h. Provider must demonstrate that the laboratory facilities where work will be conducted has the capacity for large-scale measurements in tens of thousands per-year

i. Capacity for long-term storage of biospecimens in the tens of thousands

j. Evidence of at least 100 scientific per-review publications using the technology to be deployed by the provider

k. An extensive chemical reference library (>4000) metabolites representing the following major metabolic pathways:

THIS IS A CRITICAL REQUIREMENT.

l. Ability for Sample tracking and management utilizing bar coding to ensure security & traceability of VA samples.

m. Ability to produce documentation of sample handling and processing attributes/audit trail, etc. that would address sample mixing and sample error tracking.

n. Demonstrated prior experience working with partners in government, biotechnology, and academic industries

o. Extensive working experience with unique/unrecoverable patient plasma (EDTA) samples

p. Highly desirable is expertise in statistical and pathway analysis

q. The contractor shall demonstrate that they are certified in Good Laboratory Practice (GLP)

r. Contractors shall be required to submit for a NACI low level background investigation and security clearance in accordance with the VA IT Security Clause and complete the required training and procedures to comply with these requirements.

In addition to the items above, the potential vendor must have documented quality assurance and the ability to scale to meet the sample throughput at an expected rate of 10,000 to 20,000 samples per year. This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Friday, February 26, 11AM, EST. Interest/capability statements may be sent to Elaine DiBucci at elaine.dibucci@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.