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.
AI Contract Overview
The National Institutes of Health (NIH) plans to award a non-competitive contract for clinical laboratory molecular diagnostics testing using the inVivoScribe reagents kit. This presolicitation notice, issued under solicitation number 75N98026Q00654, is intended for Invivoscribe, Inc., located in San Diego, CA. The contract falls under NAICS code 541990 with a size standard of $19.5 million and will be conducted under simplified acquisition procedures with an estimated value not exceeding the $350,000 threshold. The procurement aims to support the Molecular Diagnostics Laboratory of the NIH’s Laboratory of Pathology, which specializes in molecular testing to aid in cancer diagnosis and personalized therapy. Specifically, the contract covers reagents for detecting clonal immunoglobulin gene rearrangements, which assist in the identification, monitoring, and assessment of B-cell malignancies and other hematologic cancers, as well as a control ladder for determining DNA sample quality. This acquisition is issued as a single-source solicitation without full and open competition, following federal regulations that exempt it from standard competitive requirements. While this is not a request for competitive proposals, interested parties may submit capability statements along with technical and cost proposals by June 29, 2026, at 9:00 AM Eastern time. Responses must include relevant business and registration information, such as Unique Entity ID and System for Award Management (SAM) registration, and be sent electronically to the designated contracting officer. The government reserves the right to determine whether to proceed on a non-competitive basis or pursue competition based on the submissions received. The performance location is Bethesda, Maryland, where the NIH Office of Acquisition and Logistics Management will oversee the contract.
General Info
Agency
NAICS
Place of Performance
Bethesda, MD, 20892, USASet-Aside
Documents
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Timeline
Response Deadline
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.”