Q301--Exosome Diagnostics - ExoDx testing FY22 (VA-22-00039685)

LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Contracting Activity: Department of Veterans Affairs, VISN 6, Hunter Holmes McGuire VA Medical Center, 652-22-2-096-0072 (2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Order against: FSS Contract Number: 36F79720D0097 Name of Proposed Contractor: Exosome Diagnostics, Inc. Street Address: 266 Second Ave, Suite 200 City, State, Zip: Waltham, MA 02451 Phone: 844-396-7663 (3) Description of Supplies or Services: The estimated value of the proposed action 1. The Richmond VAMC Laboratory Department has a request for the following service for prostate testing. The ExoDx Prostate Test is a simple, non-DRE, urine-based, liquid biopsy test indicated for men 50 years of age and older with a prostate-specific antigen (PSA) 2-10ng/mL, or PSA in the gray zone , considering an initial biopsy. The ExoDx Prostate test returns a risk score

that determines a patient s risk of clinically significant prostate cancer (Gleason Score 7) on prostate biopsy. A score above the validated cut-point of 15.6 is associated with an increased likelihood of GS 7 PCa on a biopsy and a score below the cut-point of 15.6 is associated with a decreased likelihood of GS 7 PCa. This test can help reassure a patient to avoid a prostate biopsy or improve patient compliance with physician recommendations. ExoDx is only offered by Exosome Diagnostics, and service on the Federal Supply Schedule, contract number 36F79720D0097. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. (CHECK THE APPLICABLE AUTHORITY BELOW AND COMPLETE) FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering, procedures would result in unacceptable delays: Specify the urgency/compelling need. FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; "ExoDx Prostate Test (Intelliscore) is a non-DRE urine-based liquid biopsy test indicated for men 50 years of age and older with a PSA 2 10 ng/mL being considered for an initial prostate biopsy. A patient-specific risk score is calculated based on a proprietary algorithm that combines the weighted expression of a three-gene signature in exosomal RNA. Exosome Diagnostics is the only company that can provide ExoDx testing. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. Specify how the new work is a logical follow-on to the original order and confirm that the original order was not issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: "ExoDx Prostate Test (Intelliscore) is a non-DRE urine-based liquid biopsy test indicated for men 50 years of age and older with a PSA 2 10 ng/mL being considered for an initial prostate biopsy. A patient-specific risk score is calculated based on a proprietary algorithm that combines the weighted expression of a three-gene signature in exosomal RNA. These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit, and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: Exosome Diagnostics is the only company that offers ExoDx, and they have a GSA contract, 36F79720D0097 and price has already been deemed fair and reasonable. (6) Describe the Market Research Conducted: The Contracting Officer conducted further market research showing the following; The query VIP returned 97 SDVOSB and 7 VOSB under the NAICS 621511 with the keyword prostate intelliscore. GSA showed 14 vendors with key work search (prostate) VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Page 3 of 4 (testing) that provide prostate testing but only one that can provide the prostate intelliscore testing which consists of having a three-gene signature in exosomal RNA. SBA shows one vendor under NAICS 621511; MDx Health, a small business that provides a similar prostrate test, but their test only has two biomarkers instead of three. Exosome Diagnostics FSS Contract 36F79720D0097 provides the ExoDo Prostate intelliscore testing. This prostate test is a non-DRE urine-based liquid biopsy test indicated for men 50 years of age and older with a PSA 2 10 ng/mL being considered for an initial prostate biopsy. A patient-specific risk score is calculated based on a proprietary algorithm that combines the weighted expression of a three-gene signature in exosomal RNA. A score above the cut point is associated with an increased likelihood of GS 7 PCa on subsequent biopsy. Specimens are collected and set to the vendor for testing among schedule holders and the results or a statement of the reason market research was not conducted. Exosome Diagnostics is the only company that offers ExoDx under their GSA contract, 36F79720D0097. (7) Any Other Facts Supporting the Justification: none (8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made. N/A (9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.