This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on June 17, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Clinical Laboratory Molecular Diagnostics Test using inVivoScribe reagents kit.
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The National Institutes of Health, through its Office of Logistics and Operations and Office of Acquisition and Logistics Management, intends to award a non-competitive contract to Invivoscribe, Inc. for the provision of Clinical Laboratory Molecular Diagnostics Test reagents, specifically the inVivoScribe IgH + IgK B-cell clonality assay kits and Specimen Size Control Ladder, to support molecular oncology testing for cancer diagnosis, prognosis, and residual disease assessment. This procurement is classified under NAICS code 541990 with a size standard of $19.5 million and will be executed under the Federal Acquisition Regulation Part 13 Simplified Acquisition Procedures, with an estimated value not exceeding $350,000, exempting it from full and open competition requirements. The contract will incorporate all applicable provisions from FAC 2026-01 and is authorized under FAR 13.106-1(b)(1) for single-source procurement due to the unique capabilities of Invivoscribe’s proprietary reagents, which are currently used by the only CLIA- and CAP-certified molecular diagnostics laboratory within the NCI serving NIH patients. This presolicitation notice is not a request for competitive bids but serves as an announcement of intent to negotiate a non-competitive award, though interested parties may submit capability statements, technical proposals, cost-price proposals, and required certifications, including a Unique Entity ID, Taxpayer Identification Number, and business size certification, to be considered for potential competition. All submissions must be received by June 29, 2026, at 9:00 AM Eastern Time and must be sent electronically to James Law, Contracting Officer, at James.Law@nih.gov, with no faxed responses accepted. Respondents must maintain an active SAM registration and clearly reference solicitation number 75N98026Q00654. The government reserves full discretion to determine whether to proceed non-competitively or reopen the procurement based on responses received, acknowledging that all responsible sources may submit information to be evaluated for future award decisions.
General Info
Agency
NAICS
Place of Performance
Bethesda, MD, 20892, USASet-Aside
Documents
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Timeline
Submission Closed
Organization & Contact Information
Full Description
General Information
Document Type:
Presolicitation
Synopsis Number:
75N98026Q00654
Posted Date:
June 17, 2026
Original Response Date:
June 29, 2026
Current Response Date:
June 29, 2026
Set Aside:
N/A
NAICS Code:
541990
Contracting Office Address
National Institutes of Health (NIH), Office of the Director (OD)
Office of Logistics and Operations (OLAO)
Office of Acquisition and Logistics Management (OALM)
Hospital and Laboratory Support Division
6701 Rockledge Drive
Bethesda, MD 20817
Description
INTRODUCTION
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).
The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:
Invivoscribe, Inc.
10222 Barnes Canyon Road Building 1
San Diego, CA 92121
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 541990 with a Size Standard $19,500,000.
REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01, March 13, 2026. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000).
STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.
GENERAL INFORMATION
- Title: Clinical Laboratory Molecular Diagnostics Test using inVivoScribe reagents kit.
- Background Information: The Molecular Diagnostics Laboratory of the Laboratory of Pathology performs molecular testing to assist in the diagnosis of a variety of cancers. The laboratory develops tests that assist in pathologic diagnosis, predict prognosis and identify potential targets for rational personalized therapies. It is currently the only CLIA and College of American Pathology approved clinical laboratory within the NCI certified for performing molecular oncology testing on materials from NIH patients. InvivoScribe IgH +IgK B-cell clonality Assays is for identification of clonal immunoglobulin heavy chain and kappa light chain gene rearrangement, which are useful for the detection of variety B-cells malignancies, lineage determination of leukemias and lymphomas, monitoring and evaluation of disease recurrence, detection and assessment of residual disease in cancer patients.
Specimen Size Control Ladder is for identifying the amplifiable fragmented DNA in the sample, which is useful to determinate the quality of each patient DNA sample.
CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by June 29, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98026Q00654. Responses may be submitted electronically to Mr. James Law, Contracting Officer at James.Law@nih.gov. Fax responses will not be accepted.
"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”
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