NOI for InvivoScribe IGH+IGK Clonality Mega-ABI Assays
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of Health and Human Services (HHS), specifically the National Cancer Institute (NCI), has issued a Notice of Intent (NOI) to award a sole source contract to InvivoScribe, Inc. for InvivoScribe IGH+IGK Clonality Mega-ABI Assays. This action is based on the determination that InvivoScribe is the only responsible source capable of meeting the agency's specific requirements. While this is not a request for competitive proposals, interested parties may submit capability statements by February 17, 2026, at 10:00 AM ET.
Purpose & Scope
This NOI signifies NCI's intent to procure InvivoScribe IgH +IgK B-cell clonality Assays for its molecular laboratories. These assays are crucial for identifying clonal immunoglobulin heavy chain and kappa light chain gene rearrangement, which are essential for detecting B-cell malignancies, determining lineage in leukemias and lymphomas, and monitoring disease recurrence. A Specimen Size Control Ladder is also required to identify amplifiable fragmented DNA in samples. The NCI's Molecular Diagnostics Laboratory has been using these specific reagents since 2009, citing consistency and reproducibility as key factors.
Contract Details
- Type: Sole Source Contract (Notice of Intent)
- Intended Awardee: InvivoScribe, Inc. (1022 Barnes Canyon Road, Building 1, San Diego, CA 92121)
- Period of Performance: Within 15 days after award
- Product Service Code: 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits And Sets)
- NAICS Code: 325413
- Place of Performance: San Diego, CA, United States
Submission & Evaluation
This is not a request for competitive proposals or quotations. However, eligible and responsible sources who believe they can meet the requirement may submit a capability statement. Submissions must be in writing via email to Ahmed Hassan (Ahmed.Hassan@HHS.gov) and Caran Fizer (Caran.fizer@hhs.gov). Only electronic documents will be accepted.
Eligibility / Set-Aside
This is a sole source award to InvivoScribe, Inc. There is no set-aside designation. Eligible offerors must have an active registration in SAM.gov.
Additional Notes
The NCI's Molecular Diagnostics Laboratory is the only CLIA and College of American Pathology approved clinical laboratory within the NCI certified for performing molecular oncology testing on NIH patient materials. InvivoScribe is identified as the sole provider of the specific IGH/IGK kit required by the NCI.