B.1.4 NOI PCA-NHGRI-10510 Statement of Need .docx
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- Attached to
- Notice of Intent to Award to a Single Source
- Solicitation number
- PCA-NHGRI-10510
About this file
This is a Statement of Need for a single-source procurement by the National Human Genome Research Institute (NHGRI), a component of the National Institutes of Health under the Department of Health and Human Services. NHGRI requires replacement of an existing, non-operational Meridian BreathID instrument to continue ongoing patient history studies and support an upcoming clinical trial. The replacement unit must be the same model as the current instrument to maintain consistency in sample analysis, instrument performance, data collection, and study procedures. The BreathID is used to conduct propionate oxidation breath tests that measure whole body enzyme activity in patients with rare genetic disorders affecting the mitochondrial pathway. The requirement is critical to prevent interruptions in research activities and data collection that track patient health over time and measure the effectiveness of future gene therapy clinical trials.
The procurement is being conducted on a sole-source basis with Meridian BioScience under the authority of 41 U.S.C. 3204(b)(2), as Meridian is identified as the owner and developer of the required product. The requirement includes provision of a 4-year extended warranty for the unit. However, the government has issued a Notice of Intent to Award inviting other vendors to submit capability statements demonstrating their ability to provide comparable products that would fully satisfy the requirement while accounting for the continuity needs of ongoing research studies. Any interested parties must submit written documentation addressing compatibility concerns prior to the closing date specified in the notice, with evaluation solely determining whether to conduct the procurement on a competitive basis.
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Other files
| File | Type | Posted |
|---|---|---|
| A.3 Award Notice.docx | DOCX document |
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PCA-NHGRI-10510 Meridian BreathID replacement
Statement of Need: A replacement Breath ID instrument is required to replace the existing unit, which is no longer operational. The replacement must be the same model as the current instrument to ensure consistency and continuity in the ongoing patient history studies and for an upcoming clinical trial this fall. Using the same model is necessary to maintain consistency in sample analysis, instrument performance, data collection, and study procedures. Introducing a different model could create variability in measurements or require changes to established study methods, potentially affecting comparability of data collected before and after replacement. The replacement is also critical to the continuation of important ongoing patient-history studies that rely on this instrument for data collection and analysis. Without a functioning Breath ID instrument, we will be unable to continue these studies as planned, which could result in interruptions to data collection and delays in research activities.
Purpose and Need
This machine is used on patients with rare disorders enrolled in our natural history and gene therapy protocols for a breath test (propionate oxidation breath test) that measures whole body enzyme activity of their respective disease gene.
Support of NIH/HHS Mission This replacement directly supports NHGRI’s mission to advance genomic research and the development of innovative genomic therapeutics. The government requires a replacement BreathID machine to enable measurement of propionate metabolism in patients with genetically inherited disorders of that mitochondrial pathway both to track health in the patient population over time and to determine the effectiveness of future clinal trial therapies.
Limitations of Current In-House Capabilities Our current equipment is no longer operational or reliable and there is no other effective in-house method to replace this system.
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