SAM #75N98026Q00654

NIH Procurement of Invivoscribe Molecular Diagnostics Testing Services

This procurement opportunity is issued by the National Institutes of Health (NIH), Office of Logistics and Operations (OLAO), Hospital and Laboratory Support Division. - The NIH seeks clinical laboratory molecular diagnostics testing services using reagents kits from Invivoscribe, Inc. - OEM Highlight: Invivoscribe, Inc. is the sole manufacturer and vendor specified for this requirement. - Products/Services Requested: - Molecular diagnostics testing services utilizing Invivoscribe IgH + IgK B-cell clonality assays - Use of Specimen Size Control Ladder for DNA quality assessment - Purpose and Application: - Identification of clonal immunoglobulin heavy chain and kappa light chain gene rearrangement - Diagnosis of B-cell malignancies, leukemia, and lymphoma - Monitoring disease recurrence and residual disease in cancer patients - Notable Requirements: - Brand-name only procurement; no substitutes accepted - No specific part numbers or quantities provided in the notice - NAICS code: 541990 (All Other Professional, Scientific, and Technical Services) - Procurement conducted under FAR Part 13 Simplified Acquisition Procedures

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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