Q515 - Notice of Intent to Sole-Source Requirement: Artera AI Prostate Exam Testing - Cleveland VAMC

Notice of Intent to Sole-Source Requirement The Department of Veterans Affairs, Network Contracting Office (NCO) 10, intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The associated NAICS code for this is 541380, Size Standard is $19 Million. Product Service Code (PSC) is Q515. The sole-source contract will be awarded to:

ARTERA, INC UEI: S8PHW2AWT2R7 Description of requirements: The VA Northeast Ohio Healthcare System (VANEOHS) requires access to specialized multi-modal artificial intelligence (MMAI) prostate risk stratification testing of prostate biopsies or surgical specimens to assess the likelihood and severity of prostate recurrence or progression. Multi-modal artificial intelligence (MMAI) is a precision medicine platform designed to optimize cancer treatment, primarily for prostate and breast cancer patients. This testing consists of the following to generate patient specific prostate cancer risk stratification:

Data Integration: Artera AI analyzes H&E-stained pathology slides alongside patient clinical information, such as age, tumor stage, and lab results;

Predictive Modeling: The AI algorithm predicts which patients are likely to benefit from specific therapies, such as short-term androgen deprivation therapy (ST-ADT) in prostate cancer;

Outcome Estimation: It estimates long-term outcomes, including disease progression and metastasis risk, helping clinicians tailor treatment plans Artera AI Prostate is the first MMAI test recommended in the NCCN Clinical Practice Guidelines for prostate cancer. It identifies patients who may benefit most from hormone therapy and supports early-stage treatment decisions.

Benefits of this testing are early intervention providing actionable insights to guide therapy selection and improve patient outcomes for our prostate cancer patients. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This notice of intent is not a request for competitive proposals.

IAW FAR 5.207 all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. This is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that demonstrates the ability to comply with the requirement and that competition would be advantageous to the Government. The Government will not pay for information submitted.

A determination not to compete based on responses to this notice is solely within the discretion of the Government. All responses to this intent to sole source must be emailed to Thomas Bellamy: thomas.bellamy@va.gov and Samantha Jarrett: samantha.jarrett@va.gov by 3:00 p.m. EST November 10th, 2026.