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A--Intent to Sole Source Olsteoarthritis Biomarker Protocol

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VA26815Q0029Federal

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The VA Office of Research and Development at the Salt Lake City VA Medical Center is planning to negotiate a sole source contract with Artialis for specialized biomarker assay testing in support of a VA-approved clinical research project on knee osteoarthritis. This sole source acquisition is being pursued under FAR 6.302-1, and while this notice does not solicit competitive proposals, other capable parties may submit capability statements within five days. The government retains full discretion over whether to proceed with competitive procurement based on those submissions. The contractor, Artialis, will be responsible for performing biomarker tests as part of a double-blinded clinical trial involving 160 knee osteoarthritis patients. The patients will be evaluated at Baseline, 12, 24, and 48 weeks, with biomarker assays conducted at each interval. The specific biomarkers to be analyzed include CTXII, Coll2-1, Coll2-1-NO2 in urine and serum, and s-COMP in serum. These biomarkers are critical for assessing cartilage degradation and inflammatory processes involved in osteoarthritis progression. This contract under the NAICS code 541380 aims to support precise and timely data collection essential to the research study’s success.

General Info

Sole source contract with Artialis for biomarker testing in knee osteoarthritis clinical trial.

Agency

N/A

NAICS

541380 - Testing Laboratories and Services

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

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special-notice

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Organization & Contact Information

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AgencyN/A
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Full Description

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The VA Office of Research and Development, Salt Lake City VA Medical Center, Research Department intends to negotiate on a sole source basis with contractor Artialis pursuant to FAR 6.302-1; for services in support of a VA approved research project. 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 within 5 days of this posting. Interest/capability statements may be sent to Keith Costantino at contact@example.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. A description of the required services are as follows: The VA Salt Lake City research department requires the services of Artialis, to provide biomarker assay testing for the Salt Lake City research departments double blinded clinical trial for knee osteoarthritis patients. The study requirements consist of 160 patients being evaluated by the VA at Baseline, 12 weeks, 24 weeks and 48 weeks. Biomarker tests will be performed at each interval by the contractor. The biomarkers will be CTXII, Coll2-1 (a degradation produce to type II collagen whose concentration increases in osteoarthritis disease, consequently to the cartilage degradation) and Coll2-1-NO2 (the nitrated form of Coll2-1, a marker of the inflammatory process related to the cartilage degradation) in urine and serum, and s-COMP in serum.

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