Q301--NEW - Karius Next Generation Sequencing Test B+3
ID: 36C25725Q0270Type: Special Notice
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF257-NETWORK CONTRACT OFFICE 17 (36C257)ARLINGTON, TX, 76006, USA

NAICS

Medical Laboratories (621511)

PSC

MEDICAL- LABORATORY TESTING (Q301)

Original Source

https://sam.gov/opp/80d74bcc22b649d787a4437212f70815/view
Timeline
    Description

    The Department of Veterans Affairs (VA) is planning to award a firm-fixed-price contract to Karius, Inc. for the provision of the Karius Test®, a next-generation sequencing blood test designed to detect over 1,000 pathogens through microbial cell-free DNA analysis. This contract aims to enhance the rapid diagnosis and treatment of infections, particularly for immunocompromised patients, within the Texas Valley Coastal Bend Health Care System (TVCBHCS) in Harlingen, TX. The Karius Test® is recognized for its non-invasive nature and high diagnostic accuracy, making it a critical tool in the VA's healthcare offerings. Interested parties may submit capability statements within 10 days of this notice's publication; however, if no affirmative responses are received, the contract will be awarded to Karius, Inc. For further inquiries, interested firms should contact Ognian Ivanov at ognian.ivanov@va.gov or (210) 620-1571.

    Point(s) of Contact
    Ognian IvanovContract Specialist
    (210) 620-1571
    ognian.ivanov@va.gov
    Files
    Title
    Posted
    36C25725Q0270.docx
    The Department of Veterans Affairs (VA) plans to award a firm-fixed-price contract to Karius, Inc. for providing the Karius Test®, a next-generation blood test for detecting over 1,000 pathogens through microbial cell-free DNA analysis. This service will specifically cater to the Texas Valley Coastal Bend Health Care System (TVCBHCS) in Harlingen, TX. Karius, Inc. is identified as the exclusive source for this test, with the procurement being justified under 41 U.S.C. 3304(a)(1) due to the unavailability of equivalent alternatives. This notice serves as a call for capability statements from interested parties who may want to offer similar services, with a response deadline set for 10 days post-publication. If there are no affirmative responses, the contract will proceed to Karius, Inc. There are additional instructions regarding communications with the point of contact and the absence of a solicitation for proposals or quotations. The document reinforces the VA's adherence to regulatory frameworks while ensuring access to unique medical testing services for veterans.
    SOW Karius Test.docx
    The Texas Valley Coastal Bend Health Care System (TVCBHCS) seeks to contract Karius Next Generation Sequencing testing to enhance the rapid diagnosis and treatment of infections, particularly in immunocompromised patients. The Karius test is notable for its non-invasive nature and high diagnostic accuracy, identifying over 1,000 pathogens from a plasma sample. The contractor is responsible for specimen transportation, testing, analysis, and timely reporting of results, ensuring compliance with CLIA standards and offering communication channels for status inquiries. Security and confidentiality of patient data are paramount, requiring contractors to adhere to strict HIPAA regulations and undergo background checks. The contract spans from April 1, 2025, to March 31, 2029, with provisions for quality control, testing methodology changes, and thorough documentation of test results. Compliance with information security protocols and regular audits will be essential for safeguarding sensitive patient information. This engagement reflects the VA's commitment to utilizing innovative technologies for improving healthcare outcomes while maintaining stringent security and confidentiality standards.
    Lifecycle
    Title
    Type
    Q301--NEW - Karius Next Generation Sequencing Test B+3
    Currently viewing
    Special Notice
    Similar Opportunities
    6640--FY25 Q3 Micro Molecular Testing (VA-25-00029953)
    Buyer not available
    The Department of Veterans Affairs (VA) is issuing a presolicitation notice for the procurement of Micro Molecular Testing supplies for the West Palm Beach VA Hospital, under Solicitation No. 36C24825Q0395. The procurement includes various laboratory items and equipment, such as testing kits and the leasing of laboratory instruments, with a requirement for vendors to be Authorized Distributors and provide proof of their status. This initiative is part of the VA's commitment to enhancing its laboratory capabilities to effectively serve veterans. Interested vendors must submit their quotations via email by March 12, 2025, at 2:00 PM Eastern Time, and are encouraged to stay updated on any changes to the solicitation through the Beta-Sam website. For further inquiries, vendors can contact Contract Officer David Henry at David.Henry3@va.gov or by phone at 561-631-3352.
    Q301-- Five (5) Full-Time Equivalent Certified Medical Technologists
    Buyer not available
    The Department of Veterans Affairs is seeking to procure the services of five full-time certified Medical Technologists to support the Public Health National Program Office. These professionals will be responsible for performing high-complexity molecular laboratory testing and laboratory information management services, which are critical for the nation's biodefense strategy and public health preparedness, particularly in diagnosing emerging pathogens and high-consequence infections. Interested vendors must respond with their company details and capabilities by March 13, 2025, with a preference for submissions from service-disabled veteran-owned and veteran-owned small businesses. For further inquiries, potential respondents can contact Contracting Officer Larry Facio at Larry.Facio@va.gov or by phone at 916-923-4553.
    Q301--Biodesix, Inc. (621 II) (PENDING PROPOSAL)
    Buyer not available
    The Department of Veterans Affairs is soliciting proposals for reference laboratory services under the Federal Supply Schedule (FSS) program, specifically for medical laboratory testing related to disease diagnosis and patient health assessment. The procurement aims to establish contracts for services that comply with federal, state, and local regulations, including necessary licensing and accreditation, while ensuring that only new items are provided and that grey market goods are strictly prohibited. This opportunity is critical for enhancing the quality of healthcare services provided to veterans, with a focus on compliance with the Trade Agreements Act and other regulatory requirements. Interested vendors should contact Contract Specialist Brian O'Connell at Brian.O'connell@va.gov for further details, and they must adhere to the submission deadlines outlined in the solicitation documents.
    6640--Notice of Intent (NOI) to Sole Source to Roche Diagnostics. Cobas 6800 system, assays, reagents and supplies.
    Buyer not available
    The Department of Veterans Affairs (VA) intends to award a Sole Source contract to Roche Diagnostics for the provision of equipment and supplies related to the Cobas 6800 system, which is critical for conducting various medical tests including those for HIV, HCV, HBV, HPV, and SARS-CoV-2. This procurement involves a Firm-Fixed-Price Indefinite Delivery Indefinite Quantity (IDIQ) contract, structured with a base year and four additional ordering periods, ensuring a reliable supply of assays, reagents, controls, and consumables necessary for routine medical testing at the Central Arkansas Veterans Healthcare System (CAVHS). The initiative aims to enhance diagnostic capabilities while maintaining high standards for quality, safety, and regulatory compliance, reflecting the VA's commitment to efficient healthcare delivery for veterans. Interested parties must submit their qualifications and any evidence of capability to compete for this contract to Contracting Officer Anthony Marion via email by March 25, 2025, with the anticipated award date set for May 1, 2025.
    Q301--Unrestricted- Immunohistological Stains Reference Testing for Rocky Mountain Regional VA Medical Center
    Buyer not available
    The Department of Veterans Affairs is seeking proposals for a five-year Blanket Purchase Agreement (BPA) for immunohistological stains reference testing at the Rocky Mountain Regional VA Medical Center. The contractor will be responsible for providing a range of laboratory testing services, including immunohistochemical stains and molecular testing for various malignancies, with a focus on maintaining high accuracy and quick turnaround times without specimen splitting. This procurement is crucial for ensuring timely and comprehensive healthcare services for veterans, with an estimated award amount of $41.5 million for the contract period from July 1, 2025, to June 30, 2030. Interested parties should contact Contract Specialist Karly L Morris at Karly.Morris@va.gov for further details and to discuss collaboration opportunities, particularly for service-disabled veteran-owned small businesses.
    ClonoSEQ Reference Testing Service
    Buyer not available
    The Department of Defense, specifically the Department of the Army, is planning to award a sole-source firm fixed contract for ClonoSEQ Reference Testing Services to Adaptive Biotechnologies Corporation. This procurement involves providing FDA-cleared in vitro diagnostic testing services, which include 15 genomic sequence analyses per year, and will be managed under FAR Part 13, Simplified Acquisition Procedures, covering a base year plus four optional years. These specialized medical laboratory services are crucial for maintaining medical readiness within the military. Interested providers must contact Colleen M. Rye by March 14, 2025, to demonstrate their capability to deliver the required services, as the award will be based on the lowest price/technically acceptable proposal, focusing exclusively on brand name products.
    6550--GenMark ePlex Reagents - Notice of Intent to Sole Source
    Buyer not available
    The Department of Veterans Affairs (VA) intends to negotiate a sole source contract for GenMark ePlex Reagents, specifically the ePlex Respiratory Pathogen Panel 2, to support testing for respiratory viruses, including COVID-19, at the Chillicothe VA Medical Center in Ohio. This procurement is justified under FAR Part 6.302-1, which allows for contracts with a single responsible source when only one vendor, Roche Diagnostics Corp., is deemed capable of fulfilling the specific requirements due to the unique compatibility of the reagents with the existing GenMark ePlex Analyzer. The anticipated contract will be a firm fixed price with no option years, and responses to this notice must be submitted by 4:00 pm EST on March 13, 2025, to Contract Specialist Lonnelle Jones at lonnelle.jones@va.gov.
    Alinity mp Pre-Analytical System
    Buyer not available
    The Department of Veterans Affairs is seeking qualified vendors to provide the Alinity mp Pre-Analytical System for the VA Northern California Healthcare System (VANCHCS) located in Mather, California. This procurement aims to enhance the efficiency of testing for sexually transmitted infections (STIs) and HPV by automating the aliquoting of liquid-based cytology samples, thereby addressing critical staffing shortages and reducing sample handling errors. The initiative is particularly important given the high prevalence of HPV-related conditions among the veteran population, and the selected system must be compatible with existing infrastructure while adhering to space limitations. Interested parties are required to submit a statement of capability, along with relevant documentation, by 1:00 PM on March 20, 2025, to Jason S. Olliff at jason.olliff@va.gov. Responses should include business size, socio-economic status, and proof of authorized distribution, as well as any pertinent past performance information.
    6640--Coagulation Follow-on Contract (VA-25-00007795) 589-25-3-1598-0003
    Buyer not available
    The Department of Veterans Affairs is preparing to award a firm fixed price contract for coagulation testing services and supplies across multiple facilities within the VISN 15 network. This procurement aims to cover the cost per reportable result for PT/PTT coagulation equipment and associated testing supplies, with a contract structure that includes a base period and four optional years. The services are critical for ensuring accurate and timely coagulation testing, which is essential for patient care in various medical settings. Interested bidders must be registered and active in the System for Award Management (SAM) to participate, with the solicitation expected to be released electronically on or around March 4, 2025. For further inquiries, potential contractors can contact Contracting Officer Lisa A. Buchanan at lisa.buchanan1@va.gov or by phone at 913-946-1990.
    6515--Point of Care Testing Solution
    Buyer not available
    The Department of Veterans Affairs is seeking proposals for the procurement of Point of Care (POC) Blood Testing Units to enhance medical services at the VA Maryland Healthcare System in Baltimore, MD. The contract aims to provide clinical staff with eighteen i-STAT 1 analyzers, along with necessary components such as downloader recharger kits and training for effective integration into the Electronic Health Record (EHR). This initiative underscores the VA's commitment to improving patient care through advanced diagnostic equipment. Interested contractors must submit their proposals electronically by February 28, 2025, with the contract expected to be awarded by September 30, 2025. For further inquiries, potential bidders can contact Contracting Officer Ryan Singletary at ryan.singletary@va.gov or by phone at 202-745-8000.