SAM #36C24E26Q0118

VA sole source for cGLP-compliant histopathology services supporting neural stem cell therapy study to Virscio, Inc.

This opportunity is a sole source procurement by the Department of Veterans Affairs (VA) for specialized histopathology services supporting a neural stem cell therapy safety study in rats. - Agency: Department of Veterans Affairs, Office of Research and Development, Regional Procurement Office East - Sole source vendor: Virscio, Inc. (New Haven, CT) - Purpose: Support nonclinical toxicology study for FDA IND submission evaluating H9 spinal cord neural stem cells (H9-scNSCs) in a rat spinal cord injury model - Services required: - cGLP-compliant tissue processing, paraffin embedding, histologic sectioning - Hematoxylin and eosin (H&E) staining - Immunohistochemistry (including STEM121 marker) - Digital slide scanning - Pathology evaluation by ACVP-board-certified veterinary pathologist - Quality assurance and final pathology report preparation - Study coordination and project management (16 units) - Scope includes processing and evaluation of thousands of CNS tissue specimens, rodent brain specimens, paraffin blocks, unstained slides, H&E stained slides, and immunohistochemistry slides - Contractor must operate under 21 CFR Part 58, maintain independent Quality Assurance Unit, documented SOPs, personnel training, equipment calibration, chain-of-custody procedures, and demonstrate technical expertise in GLP-compliant histology and pathology for neural stem cell transplantation studies - Only Virscio, Inc. is considered capable of meeting these requirements - Services to be performed at contractor's facility, with deliverables due at various stages throughout the study duration

Description

The Veteran's Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA, intends to negotiate on a sole source basis with Virscio, Inc. based in New Haven, CT, on behalf of the VA San Diego Healthcare System. The requirement is to provide current Good Laboratory Practice (cGLP)-compliant histopathology services supporting a nonclinical toxicology study evaluating the safety of intraspinal administration of H9 spinal cord neural stem cells (H9-scNSCs) in a cervical hemi-contusion spinal cord injury model in athymic nude rats. The services include tissue processing, paraffin embedding, histologic sectioning, hematoxylin and eosin (H&E) staining, immunohistochemistry, digital slide scanning, pathology evaluation by an American College of Veterinary Pathologists (ACVP)-board-certified veterinary pathologist, quality assurance, and preparation of a final pathology report suitable for inclusion in an FDA Investigational New Drug (IND) application.

Specific Tasks and Deliverables:

Study Support for compliance with GLP documentation requirements SPECIFIC TASK: The Contractor shall provide scientific and administrative support necessary to execute the histopathology portion of the nonclinical safety study. Support shall include study coordination, protocol development and refinement, scheduling personnel and meetings with sponsor, sample tracking throughout each process, communication with the Sponsor, quality oversight of GLP procedures and documentation, and coordination of study activities through completion of the final report. DELIVERABLE: Specimen inventory log including the animal number, treatment group, tissue identification, date received, received by, condition upon receipt, and storage location within 1 week of receipt of tissues. Chain-of-custody documentation noting the transfer of specimens from one location to another within 1 week of receipt of tissue. Tissue Trimming received wet SPECIFIC TASK: The Contractor shall receive fixed tissues from a CRO and perform gross trimming of spinal cord, dorsal ganglia, peripheral nervous system, and peripheral organ tissues and process for paraffin embedding (except thoracic and lumbar pieces to be snap frozen and stored at -80°C) for subsequent histologic processing. CNS and PNS Tissue Trimming Tissue Location Number of Tissue blocks Section Orientation Analysis Spinal cord Cranial-2 Immediately Cranial to Cranial-1 (~3 mm block) 1 (30% sucrose), transfer to sponsor N/A N/A Spinal cord Cranial-1 Immediately Cranial (~2 mm block) 1 (FFPE) Transverse H&E <!-- Additional rows omitted for brevity --> Total FFPE blocks = 13 Total FFPE blocks for evaluation = 9 *Brachial Plexus will be collected for the 3-month and 9-month groups. 1-month samples will be stored and transferred to molecular CRO for PCR analysis.

Peripheral Organ Trimming (Group 1-6, 1 month) Tissue Number of Tissue blocks Analysis Heart 1 H&E <!-- Additional rows omitted for brevity --> Thoracic and Lumbar blocks: For all subjects (148 total). From each spinal cord level, 4 pieces of tissue (2-3 mm) will be trimmed. The most rostral block will be embedded in paraffin, and the other 3 will be snap-frozen and stored. Cranial-1 and caudal-1 blocks: For all subjects (148 total), embedded in paraffin, sectioned in the transverse plane. 12 serial sections will be cut, and the remaining block stored. All CNS tissue samples will be dehydrated through gradient alcohols, cleared in xylene, and infiltrated with paraffin wax for embedding. Quantity: 566 tissue specimens DELIVERABLE: Trimmed tissue specimens within 6 weeks of receipt and tissue preparation documentation within 6 weeks of receipt.

Tissue Trimming received rodent brain SPECIFIC TASK: The Contractor shall perform standardized trimming of rodent brain and medulla specimens according to protocol-defined anatomical landmarks to prepare tissues for paraffin embedding and histologic evaluation. Tissue Location Number of Tissue blocks Section Orientation Analysis Brain Whole 3 (FFPE) Standard H&E Quantity: 150 tissue specimens DELIVERABLE: Trimmed brain specimens within 6 weeks of receipt and tissue preparation documentation within 6 weeks of receipt.

Processing to paraffin blocks SPECIFIC TASK: The Contractor shall process protocol-specified tissues through dehydration, clearing, paraffin infiltration, embedding, and preparation of FFPE tissue blocks while maintaining specimen identity and quality control. Quantity: 928 DELIVERABLE: FFPE tissue blocks within 2 weeks of tissue trimming Histology processing records within 2 weeks of tissue trimming Quality control documentation within 2 weeks of tissue trimming

Unstained slides SPECIFIC TASK: The Contractor shall section FFPE tissue blocks and prepare unstained microscope slides: CNS/PNS Tissue. Lesion Block: For all subjects (148), sectioned in the horizontal plane. 12 serial sections (1 slide each) at each level, separated by ~200 µm, resulting in at least 6 levels. Cranial-1 and caudal-1 blocks: Sectioned in transverse plane, 12 serial sections, remaining block stored. Thoracic and Lumbar blocks: Sectioned, 1 slide each. Brain blocks: Sectioned, 1 slide each. Peripheral Tissue: For all subjects n=52 from the 1-month time point, embedded in paraffin, sectioned, 1 slide each. Quantity: 9912 DELIVERABLE: Unstained tissue slides within 8 weeks of paraffin embedding, sectioning logs, and slide inventory.

H&E with slide cutting, scanning & pathology evaluation SPECIFIC TASK: Under GLP conditions, the contractor shall perform H&E staining of specified tissue sections, and conduct microscopic evaluation by an ACVP-certified veterinary pathologist. All stains and assays will follow established methods and be quality checked. Lesion block: 1 slide from each level Cranial-1 and caudal-1 blocks: 1 slide each Thoracic and Lumbar blocks: 1 slide each Brain blocks: 1 slide each Peripheral Tissue: 52 samples from the 1-month time point, 1 slide each. Quantity: 1166 DELIVERABLE: Histopathology evaluation records within 12 weeks of paraffin embedding.

IHC - Manual per marker with scanning and evaluation SPECIFIC TASK: The Contractor shall perform manual immunohistochemical staining using protocol-specified antibodies, including the human-specific STEM121 marker, with digital slide scanning and microscopic evaluation by an ACVP-certified veterinary pathologist. Lesion block: 1 slide from each level stained for STEM121. Quantity: 900 DELIVERABLE: Pathology evaluation records within 12 weeks of paraffin embedding and IHC quality control documentation within 12 weeks.

Pathology report SPECIFIC TASK: The Contractor shall prepare a comprehensive pathology report summarizing histologic and immunohistochemical findings, including methods, observations, images, interpretations, and conclusions suitable for FDA IND submission. DELIVERABLE: Draft report within 8 weeks of slide evaluation Final report within 4 weeks of draft

Study Coordination SPECIFIC TASK: The Contractor shall provide study coordination services throughout the study, including schedule management, sponsor communication, progress monitoring, issue resolution, and routine project communications. Quantity: 16 estimated DELIVERABLE: Project management support throughout the study Written progress communications at each stage Meeting documentation including agendas, attendance, and minutes within 1 week of each meeting

6. Contractor Qualifications The Contractor shall demonstrate the qualifications and capabilities necessary to perform GLP-compliant histology and pathology services for an FDA IND-supporting study involving human neural stem cell transplantation in an athymic nude rat spinal cord injury model. At a minimum, the Contractor shall meet the following requirements:

Regulatory and Quality Requirements Operate in compliance with 21 CFR Part 58 (GLP) for all activities. Maintain an independent Quality Assurance Unit responsible for GLP inspections, audits, and quality statements. Maintain current SOPs for all procedures including tissue receipt, processing, embedding, sectioning, staining, review, data management, archiving, and reporting. Maintain documented personnel training, equipment calibration, and chain-of-custody procedures.

Technical Expertise Histological processing of rodent CNS tissues. Histopathologic evaluation of spinal cord injury models. Processing and evaluation of tissues from immunodeficient rodents. Evaluation of tissues from human cell transplantation studies. Processing FFPE and frozen tissues. Serial sectioning of spinal cord tissue in transverse and horizontal orientations. Performing H&E staining under GLP. Performing GLP immunohistochemistry with human-specific antibodies, including STEM121. Identifying donor cell engraftment, lesion morphology, inflammation, tissue repair, ectopic tissue formation, and neoplastic changes. Experience with histopathologic evaluation of spinal cord tissues following neural stem cell transplantation or similar regenerative approaches.

Pathology Qualifications Evaluations performed by an ACVP-certified veterinary pathologist or equivalent. Experience in rodent neuropathology, spinal cord injury pathology, and regenerative medicine interpretation. Capability to evaluate graft survival, donor cell persistence, inflammation, tumorigenicity, ectopic tissue formation, and tissue origin.

Laboratory Capabilities Process, embed, section, stain, and archive tissues. Produce high-quality serial sections. Perform GLP-compliant immunohistochemistry with controls. Generate and maintain digital whole-slide images. Archive slides, blocks, records, and data per GLP standards.

Previous Experience The Contractor shall demonstrate prior experience in GLP nonclinical studies supporting regulatory submissions, especially pathology data for FDA IND applications. Experience in CNS tissue evaluation, spinal cord injury models, and regenerative medicine studies is required. The Contractor shall also demonstrate familiarity with validated workflows, tissue processing, immunohistochemistry, and documentation practices aligned with FDA expectations. The ability to produce consistent, scientifically valid pathology data suitable for regulatory review is essential.

The requirement will take place at the contractor's facility. The sole source is pursuant to FAR 6.302-1, Only One Responsible Source. This notice is not a request for proposals; any responsible source capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office by Monday, Sept 7, 2026, 10:00 AM EST. Submissions should be sent to Michael Haydo at Michael.haydo@va.gov. No phone responses will be accepted. The Government's decision not to compete will be at its sole discretion.

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