Statement of Work_Pardo Blood Assay.docx

STATEMENT OF WORK FORMAT

INTRODUCTION/BACKGROUND:

We discovered that normal, healthy aging in the absence of neurodegenerative disease is associated with decline in the metabolism of the anterior cingulate cortex (ACC), a region of the brain supporting important cognitive functions such as selective attention. Furthermore, the metabolism in the ACC appears to mediate the relationship between age and attentional performance. The pathophysiology of these phenomena are entirely unknown but could provide insights into age-associated cognitive decline.

Redox stress is universally observed associated with aging from prokaryotes to humans. One hypothesis is that the high rates of metabolism occurring in the ACC result is oxidative free radicals as an outcome of oxidative metabolism. If so, ACC hypometabolism should correlate with oxidative stress as measured with the redox potential from spectroscopic measurements of healthy participants. This hypothesis, if supportive, would motivate clinical trials using antioxidants such as nicotinamide riboside. We are also exploring this relationship in PTSD participants, to examine the effect of such stress on healthy aging.

OBJECTIVE:

The objective of this study is to define normal aging related changes in the human brain to chart where pathology occurs. This will be done with MRI imaging and PET/CT scans on normal human participants. To determine that older participants are exhibiting normal aging, and not undergoing disease-related aging symptoms (eg. from Alzheimer’s, dementia, or other neurodegenerative disease), our team assesses cognitive health with chart reviews and normed neurocognitive assessments. To eliminate the influence of preclinical Alzheimer’s on our results, it is necessary to utilize available blood tests to assess Alzheimer’s risk. These blood tests will consist of APOE and p-Tau 231, which sensitively differentiate amyloid positive from amyloid negative cognitively intact patients.

The human specimen will be labeled by randomized number separate from participant’s ID number. The blood sample will be collected by the government personnel at the VA Medical Center (1 Veteran’s Drive, Minneapolis, MN 55417) and will ship the required volume to the contractor express on dry ice. The contractor shall process the blood samples using APOE and pTau217. The contractor shall deliver sample test results to the study team within 15 days of receiving the sample. The contractor shall notify the study team within 10 days upon receipt of insufficient sample (defective, incomplete, or otherwise do not meet vendor requirements), along with the reason for insufficiency. Invoices will be generated upon the initiation of the contract and at the end of each month in which samples are processed.

MAJOR REQUIREMENTS:

For the Contractor to accomplish the work under this task order/purchase order, it shall be necessary for the Contractor to complete the following tasks:

· Have published evidence of their ability to perform sensitive, repeatable, and validated APOE and pTau217 blood tests with a high sample recovery rate

· Perform tests in vendor’s lab using pre-frozen 1.5mL EDTA plasma/ 1.5mL red blood cells/ associated buffy coat.

· Perform samples as individually received (not batched) and provide results in ng/mL.

· Share results of the tests with study team within 15 days of receipt or notify of insufficient sample within 10 days of receipt.

· Invoice in Tungsten within 45 days of sending the test results to the study team.

Requirements for Contract

a) Firm-fixed price/Indefinite Delivery/Definite Quantity (IDIQ) contract to be able to purchase services/tests in smaller batches (indefinite delivery) during period of performance of the entire contract.

b) Separate task orders will be ordered against contract at time of individual study need.

c) Funding will be obligated on individual task orders.

d) Each order under a task order is active immediately upon the start date of the period of performance of the task order.

Contract Type - (IDIQ)

a) Indefinite quantity, indefinite delivery- There is no set total amount of Research Studies identified for utilizing this Blood Assay Contract. Vendor shall have the capability to satisfy all new/future Research Study Task Order submissions throughout the life of the contract.

b) Task orders will be requested as needed, defining the clin item, quantity, and dollar amount will be identified within each task order.

a. Task orders are not exceed a 12 month period.

c) This will be a 3 year IDIQ contract (Base, Year 1 & Year 2) with no option years.

Estimated Quantity for the entire Period of Performance of the Contract

The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor’s employees.

CONTRACTING OFFICER'S REPRESENTATIVE (COR):

No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification.

REPORTS/DELIVERABLES:

· Reports with APOE and PTau231 results within 15 days from receiving each sample (25 samples per year over 3 years, 75 samples total)

PERIOD OF SERVICE:

10. CONTRACTOR QUALIFICATIONS:

The contractor shall:

· provide all resources as necessary to accomplish the deliverables described in the Statement of Work except as may otherwise be specified.

· provide unique instrumentation, expertise, and infrastructure to enable the faculty, trainees, and staff to accomplish the planned.

· have expertise in providing accurate and sensitive APOE and ptau-231 assays

· have CLIA or other relevant lab certifications