SPECIAL NOTICE
A -- Research Services - Signatera Molecular Residual Disease Assay Services
- Notice Date
- 12/4/2023 1:06:51 PM
- Notice Type
- Special Notice
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E24Q0008
- Response Due
- 12/11/2023 8:59:00 AM
- Archive Date
- 02/09/2024
- Point of Contact
- Ms. Millicent Covert, Contracting Officer, Phone: (No calls accepted)
- E-Mail Address
-
millicent.covert@va.gov
(millicent.covert@va.gov)
- Awardee
- null
- Description
- Regional Procurement Office (RPO) - East intends to negotiate on a sole source basis with Natera, Inc., to perform their Signatera assay on 98 patients with esophageal cancer at 4 separate times during their medical treatment for the VA North Texas Healthcare System (Dallas). The patients will all be enrolled on a clinical trial supported through the VA Office of Research and Development (ORD). STATEMENT OF WORK Background and Scope The Research department at the VANTHCS has a research study that is being funded by the VA Office of Research and Development. This study includes seven participating VA sites with VANTHCS serving as the coordinating/lead site. Natera Inc. is the sole manufacturer and distributor for the Signatera molecular residual disease assay that combines both tumor whole exome sequencing and peripheral blood ctDNA (circulating tumor DNA) detection testing, which imperative for this study. Natera s Signatera is considered a tumor-informed test because it is custom designed for each patient to detect ctDNA secreted by that patient s individual tumor. Other assays on the market only perform ctDNA detection of specific genes (tumor-naïve) or either whole genome or whole exome sequencing of tumors without providing ctDNA detection. Although results can be obtained by separately purchasing an assay that provides whole genome or whole exome sequencing and a second assay that provides tumor naïve ctDNA detection, doing so would significantly increase cost and unacceptably delay activation of the clinical research study. Natera is the only vendor capable of providing this highly specialized and unique product specific to the requirements and timeline of this ORD-funded study. The contractor shall provide comprehensive reference laboratory services including capability and expertise to perform tumor whole exome sequencing and peripheral blood testing for molecular residual disease (MRD) in solid tumors. Services will be provided as Natera receives patient samples. This notice of intent is not a request for competitive proposals. Any responsible sources who wish to identify their interest and capability to provide this equipment or equipment that is compatible must notify this Contracting Officer at Millicent.Covert@va.gov NLT Monday, December 11, 2023, by 11:59 AM EST. Telephone responses will not be accepted. Upon receipt of the interested parties' notification, the Contracting Officer will determine whether to conduct a competitive procurement or proceed with sole source negotiations.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/f3f0c406650742eb8f395127b81e926d/view)
- Record
- SN06901253-F 20231206/231204230050 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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