NOTICE OF INTENT Invivoscribe.pdf

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT

Requisition No: 26-001837 Intended Source: InvivoScribe, Inc Period of performance: Within 15 days after award Description of Requirement: Clinical Laboratory Molecular Diagnostics Test using InvivoScribe IGH+IGK Clonality Mega-ABI Assays

This contract action is for the acquisition of services for which the Government intends to solicit and negotiate with only one source under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1(b)(1). The National Cancer Institute (NCI), Office of Acquisitions (OA) intends to award a single source purchase order to InvivoScribe at 1022 Barnes Canyon Road, Building 1, San Diego, CA 92121.

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.

The purpose of this requirement is to purchase InvivoScribe IgH +IgK B-cell clonality Assays which is for identification of clonal immunoglobulin heavy chain and kappa light chain gene rearrangement, which are also 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 also required for identifying the amplifiable fragmented DNA in sample, which is useful to determine the quality of each patient DNA sample.

All tests performed in our laboratory have been comprehensively validated based on CLIA and CAP regulations for clinical uses. Regulatory oversight requires development of Standard Operating Procedures (SOP) using defined reagents. To maintain the consistency and reproducibility of each test, the lab must order the same reagent from the same company. InvivoScribe currently is the only provider that carries this IGH/ IGK kit that fits the need of the Molecular laboratories servicing the many protocols of Clinical Center. For consistency, the lab have been using these specific reagents since 2009.

The applicable North American industry Classification System (NAICS) Code for this procurement is 325413.

Period of Performance: Within 15 days after award

NCI will solicit and negotiate directly with InvivoScribe, Inc or this requirement. This notice of intent is not a request for competitive proposals or quotations; however, eligible responsible sources may submit a capability statement which shall be considered by the agency. However, this does not compel the agency to change this acquisition to a full and open requirement. In other words, a determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. Eligible offerors must have an active registration in SAM.GOV (SAM) www.sam.gov. Interested parties must also express their interest by a submission in writing via email to Ahmed Hassan (Ahmed.Hassan@HHS.gov) and Caran Fizer (Caran.Fizer@hhs.gov) and are due by 10:00 AM, Feb 17, 2026.

Only electronic documents via email will be accepted.

http://www.sam.gov/ mailto:Ahmed.Hassan@HHS.gov mailto:Caran.Fizer@hhs.gov