36C24123Q0897.docx
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- Attached to
- Q301--Notice of Intent to Sole Source - ExoDX Prostate Intelliscore Testing - 5 Year BPA
- Solicitation number
- 36C24123Q0897
About this file
This special notice announces the Department of Veterans Affairs' intent to enter into a five-year blanket purchase agreement with Exosome Diagnostics, Inc. on a sole source basis for ExoDX Prostate Intelliscore testing. The testing is a non-DRE urine-based liquid biopsy test for men ages 50 and older with a PSA of 2-10 ng/mL being considered for an initial prostate biopsy. It provides a patient-specific risk score through a proprietary algorithm combining the weighted expression of a three-gene signature in exosomal RNA. Interested parties may respond by July 24, 2023 to provide evidence that competition would benefit the government. The notice includes five clinical item numbers for 360 units of ExoDX Prostate Intelliscore testing annually for five years. The applicable NAICS code is 621511 with a $36.5 million size standard.
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| File | Type | Posted |
|---|---|---|
| PWS - Prostate Intelliscore Testing 7.17.2023.pdf |
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Special Notice Special Notice
| SUBJECT* |
| Notice of Intent to Sole Source - ExoDX Prostate Intelliscore Testing - 5 Year BPA |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 04330 |
| SOLICITATION NUMBER* |
| 36C24123Q0897 |
| RESPONSE DATE/TIME/ZONE |
| 07-24-2023 3PM EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 30 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| PRODUCT SERVICE CODE* |
| Q301 |
| NAICS CODE* |
| 621511 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330
POINT OF CONTACT*
Contract Specialist Dewan Britton Dewan.Britton@va.gov 910-343-5300 ext. 3931 N/A
ADDITIONAL INFORMATION
| AGENCY’S URL |
| https://www.va.gov/ |
| URL DESCRIPTION |
| Department of Veterans Affairs Home Page |
| AGENCY CONTACT’S EMAIL ADDRESS |
| Dewan.Britton@va.gov |
| EMAIL DESCRIPTION |
| Contract Specialist's Email Address |
DESCRIPTION
The Department of Veterans Affairs (VISN1) hereby announces its intent to enter into a 5-year Sole Source Blanket Purchase Agreement (BPA) with EXOSOME DIAGNOSTICS, INC., 266 SECOND AVE, STE 200, WALTHAM, MA 02451-1167.
This notice is not a request for quotes, but rather a notice of intent to conduct a sole source procurement in accordance with FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements.
The applicable North American Industry Classification System (NAICS) code is 621511, with a size standard of $36.5M.
"ExoDx™ Prostate Test” (Intelliscore) is a non-DRE urinebased 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. Physicians can utilize the result in conjunction with other standard of care prognostic information to determine whether to proceed with a tissue biopsy."
YR 1 Testing - CLIN 0001:
Item: ExoDX Prostate (Intelliscore) Manufacturer: Exosome Diagnostics, Inc.
SIN# 621-200
CPT Code: 0005U Estimated Qty: 360 Unit of Issue: Year
YR 2 Testing - CLIN 0002:
Item: ExoDX Prostate (Intelliscore) Manufacturer: Exosome Diagnostics, Inc.
SIN# 621-200
CPT Code: 0005U Estimated Qty: 360 Unit of Issue: Year
YR 3 Testing - CLIN 0003:
Item: ExoDX Prostate (Intelliscore) Manufacturer: Exosome Diagnostics, Inc.
SIN# 621-200
CPT Code: 0005U Estimated Qty: 360 Unit of Issue: Year
YR 4 Testing - CLIN 0004:
Item: ExoDX Prostate (Intelliscore) Manufacturer: Exosome Diagnostics, Inc.
SIN# 621-200
CPT Code: 0005U Estimated Qty: 360 Unit of Issue: Year
YR 5 Testing - CLIN 0005:
Item: ExoDX Prostate (Intelliscore) Manufacturer: Exosome Diagnostics, Inc.
SIN# 621-200
CPT Code: 0005U Estimated Qty: 360 Unit of Issue: Year
Interested parties may identify their interests and capabilities by responding to this requirement by the due date listed on this notice. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Government. No reimbursement for any cost connected with providing capability information will be provided.
See attached document: PWS - Prostate Intelliscore Testing 7.17.2023.
| *= Required Field |
| Special Notice |
Special Notice
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