Karyotyping Upgrade and Controller Equipment

The Department of Veterans Affairs, Network

Contracting Office (NCO) 22, located at 4811 Airport Plaza Drive, Long Beach, CA 90815 is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a firm fixed price, Sole Source Award. The intended Contractor is a small vendor Applied Spectral Imaging Inc. located at 6160 Innovation Way, Carlsbad, CA 92009. The VA Greater Los Angeles Healthcare System Cytogenetics Laboratory requires a software and hardware upgrade to its existing Applied Spectral Imaging (ASI) GenASIs imaging systems to add automated (Aided) Karyotyping capability. The upgrade adds ASI s Aided Karyotyping software licenses, which provide automatic chromosome segmentation and , together with the GenASIs version 8.0 software update and the supporting hardware (high-end PCs, NVIDIA T1000 8GB graphics cards, and memory upgrades) required to run it, plus a Gen 2 stage controller and on-site installation and calibration. The upgrade covers six existing installed systems: two 9-slide scanning platforms (S/N SC230006 and SC160015), three capture stations (S/N FV110030, ASIINC0045, and BV240012), and one review station (S/N RV160046). The upgraded systems will be used in the clinical Cytogenetics Laboratory to perform automated metaphase karyotype analysis on patient specimens, reducing manual analysis time, standardizing karyotype interpretation, and improving turnaround time for chromosome studies that support Veteran diagnostic care. Applied Spectral Imaging, Inc. (ASI) is the Original Equipment Manufacturer (OEM) and the sole developer, owner, and licensor of the proprietary GenASIs imaging platform and the Aided Karyotyping software module. This requirement is not the purchase of a new, stand-alone karyotyping system; it is an upgrade to the laboratory s six existing, ASI-manufactured GenASIs systems that are already installed and in clinical production use. The following characteristics limit availability to ASI as the only source: Proprietary software and hardware. The Aided Karyotyping license, the GenASIs version 8.0 software update, and the matched hardware upgrades are proprietary to ASI and can only be licensed, installed, and integrated on ASI s own GenASIs systems. No other vendor can provide, install, or integrate this software on ASI equipment. Native integration with the installed base. The upgrade must operate on the laboratory s existing installed ASI scanning, capture, and review stations without replacing the installed microscopes, cameras, and imaging hardware. No competing product performs automatic chromosome segmentation and directly on the installed ASI GenASIs platform. Active Platinum Service Contract and warranty integrity. The systems are covered under an active ASI Platinum Service Contract, and the quoted upgrade

pricing and discounts are tied to that contract. Only the OEM can perform these software and hardware upgrades without voiding the existing warranty and service coverage. Avoidance of duplicative cost and clinical disruption. The installed ASI systems are already validated and in clinical use under CAP and CLIA

requirements. Obtaining an equivalent capability from another manufacturer would require purchasing entirely new imaging systems, full clinical revalidation, and staff retraining at duplicate capital expense; it would not be a like-for-like alternative and would interrupt patient diagnostic testing. For these reasons, no other supplier s supplies or services can meet the Government s requirement, and the requirement can be satisfied only by Applied Spectral Imaging, Inc.

Place of Performance Department of Veteran Affairs VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, CA 90073 DRAFT STATEMENT OF WORK 1. Introduction The purpose of this Statement of Work (SOW) is to obtain ASI Karyotyping Software and Controller for the cytology department in Pathology & Laboratory Medicine Department at VA Greater Los Angeles Healthcare System. 2.

Background The VAGLAHS at 11301 Wilshire Blvd, CA 90073 is part of the Desert Pacific Healthcare Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system. 3. Scope Manual metaphase organization is labor-intensive and slow. By automating chromosome segmentation and , the lab instantly recaptures countless hours of technologist time. This empowers staff to shift their focus away from tedious manual sorting and toward high-level clinical interpretation. Automated Analysis: Upgrades all scanning, capture, and review platforms to Version 8.0, integrating an Aided Karyotyping license for "automatic chromosome segmentation and ". Massive Processing Power: Replaces obsolete hardware by deploying High-End PCs to scanning systems and equipping manual capture stations with dedicated Nvidia T1000 8GB graphics cards and 8GB of memory. Precision Hardware: Installs a Gen 2 ASI Stage Controller to guarantee highly responsive, accurate slide navigation. Aggressive Cost Savings: Leverages the Platinum Service Contract to secure heavy price reductions, including a completely waived installation and calibration visit fee. Must perform automated metaphase scanning, capture, and analysis for clinical cytogenetic specimens. Must natively integrate with and upgrade the laboratory s existing installed ASI GenASIs imaging systems (scanning, capture, and review stations) without requiring replacement of the installed microscopes, cameras, or imaging hardware. Must operate on the GenASIs software platform, version 8.0, and be deliverable as a software license upgrade to systems currently under an active service contract. Must support a shared, networked karyotyping workflow across capture, scanning, and review stations so that images acquired on one station can be analyzed and reviewed on another. Must include the hardware required to run the aided karyotyping software at clinical performance, including a high-end PC, an NVIDIA T1000 8GB (or equivalent) graphics card, and a memory upgrade, where applicable to the upgraded system The scope includes delivery, installation, configuration, testing, training (as required), and support of the following items: Products: Part Code Part Name Qty CPQUGPF-S Upgrade for a Pathology Scanning System Includes: GenASIs Software Update - applicable for system(s) with 8 software version (under service contract) platinum Aided Karyotyping Scanning & Analysis software license, for automatic chromosome segmentation and High-End PC Upgrade Pathology Scanning PL -System Number: SC230006 & SC160015 2 CPQUGHA-R Upgrade for Review System to Software Version 8.0 Includes: GenASIs Software Update - applicable for system(s) with 8 software version (under service contract) platinum Aided Karyotyping Analysis software license, for automatic chromosome segmentation and Upgrade Review PL (All PL) -System Number: RV160046 1 CPQUGHA-M Upgrade for Cyto Manual System to Software Version 8.0 Includes: GenASIs Software Update - applicable for system(s) with 8 software version (under service contract) platinum Aided Karyotyping Capture & Analysis software license, for automatic chromosome segmentation and Graphic Card Nvidia T1000 8GB Memory 8GB Upgrade Cytogenetic Manual PL -System Number: FV110030 3 FPRSP0069 Stage Controller Gen.2 1 FPRSV0050 Visit fee (support, system move or installation) for an ASI Engineer - for up to 2 working day, out of Warranty and Service. 1 Salient Characteristics Aided Karyotyping Software Upgrade: Must provide fully automatic chromosome segmentation and (aided karyotyping) to reduce manual analysis time and improve consistency of clinical karyotype results. Must perform automated metaphase scanning, capture, and analysis for clinical cytogenetic specimens. Must natively integrate with and upgrade the laboratory s existing installed ASI GenASIs imaging systems (scanning, capture, and review stations) without requiring replacement of the installed microscopes, cameras, or imaging hardware. Must operate on the GenASIs software platform, version 8.0, and be deliverable as a software license upgrade to systems currently under an active service contract. Must support a shared, networked karyotyping workflow across capture, scanning, and review stations so that images acquired on one station can be analyzed and reviewed on another. Must include the hardware required to run the aided karyotyping software at clinical performance, including a high-end PC, an NVIDIA T1000 8GB (or equivalent) graphics card, and a memory upgrade, where applicable to the upgraded system. Must be validated for clinical in vitro diagnostic use (IVDR compliant / FDA-cleared product family) consistent with CAP and Joint Commission