Single Source Justification MPT to SAT Signed.pdf

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#: 36C257‐25‐AP‐1839

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C257-25-AP-1839 JOFOC Log Number: FY25-NCO 17-795

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 17, located at

5441 Babcock Rd, Suite 302 San Antonio, TX 78240, in support of Texas Valley Coastal Bend Health Care System (TVCBHCS) 2601 Veterans Drive Harlingen, TX 78550-8942.

Requisition Number (2237): 740-25-3-2121-0048.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Karius Next Generation Sequencing Test is a unique Laboratory Developed Test (LTD) which identifies and quantifies microbial cell-free DNA from plasma using metagenomic next generation sequencing technology. The test is unique because it is non-invasive and does not require a specimen from the site of infection. The Karius test is the only test of its kind currently on the market as a non-invasive approach for rapid, high yield diagnosis of over 1,000 clinically relevant pathogens, including bacteria, fungi, parasites, and DNA viruses. In a landmark validation study published in Nature Microbiology, Karius test was found to have >95% sensitivity and >99.99% specificity when compared to hundreds to clinical samples with known infectious status.

Estimated amount to include option years: $245,000.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Karius Test® is a diagnostic tool that uses next-generation sequencing (NGS) to analyze microbial cell-free DNA (cfDNA) in blood plasma. It is designed to detect over 1,000 pathogens, including bacteria, fungi, DNA viruses, and protozoa, from a single blood draw. This non-invasive test provides rapid and comprehensive results, typically within 24 hours of sample receipt, making it an invaluable tool for diagnosing infectious diseases, particularly in critically ill or immunocompromised patients.

Key Features o Pathogen Detection: Identifies a wide range of pathogens down to the species level, including those that are difficult to culture or require invasive biopsies.

o Applications: Used for diagnosing conditions like pneumonia, febrile neutropenia, endocarditis, invasive fungal infections, and fever of unknown origin.

o Speed: Results are available faster than traditional methods, which can take days to weeks.

o Non-Invasive: Reduces the need for invasive procedures by detecting cfDNA from bloodstream and deep-seated infections.

Clinical Benefits o Higher Diagnostic Yield: Detects pathogens missed by conventional methods and remains effective even when patients are on antibiotics.

o Optimized Treatment: Helps clinicians adjust antimicrobial therapies based on pathogen identification and antimicrobial resistance data.

o Avoids Delays: Provides actionable results quickly, improving outcomes in time-sensitive cases

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C257‐25‐AP‐1839

Process The test involves:

i. Collecting a standard blood sample.

ii. Extracting cfDNA from plasma.

iii. Performing high-depth sequencing and bioinformatics analysis in a CLIA-certified lab to identify pathogens.

The Karius Test® is a proprietary laboratory-developed test (LDT) based on next-generation sequencing (NGS) of microbial cell-free DNA (cfDNA), developed and commercialized by Karius, Inc. It is protected by intellectual property derived from Stanford University and utilizes proprietary technology in genomics and artificial intelligence.

As a small business, Karius, Inc. is the sole source provider for this service.

4. Description of market research conducted and results or statement why it was not conducted:

Market Research was conducted in accordance with FAR part 10 and VAAR part 810.

DSBS search for Veteran Owned Small Business or Joint Venture and Service-Disabled Veteran Owned Small Business or Joint Venture rendered five results of the five, only Karius Inc. can perform this service. Keywords and NAICS code used: “Karius Sequencing Test”, 621511.

AbilityOne Market Research utilizing keywords “Karius Sequencing Test” rendered zero results.

A search in UNICOR utilizing keywords “Karius Sequencing Test” rendered zero results.

A search in FPDS rendered multiple recent noncompetitive awards made to Karius Inc., a small business vendor.

A search in GSA Advantage utilizing keywords “Karius Test” rendered zero results.

Conducting market survey: A Notice of Intent to Sole Source was publicly posted for ten days

(February 3, 2025 - February 13, 2025) to allow interested parties to submit objections or express interest. No responses were received.

Karius, INC., has submitted a Sole Source letter that confirms they are the sole source provider of the Karius Test®; that it is not available from any other source, and that no other product serves the same purpose.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

MICHAEL J. TUSINGER Date Contracting Officer, Branch Chief Lab Support Team Network Contracting Office 17