Contract Opportunity Type: Special Notice (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Aug 26, 2021 12:55 pm EDT
Original Response Date:
Inactive Policy: Manual
Original Inactive Date:
Oct 25, 2021
Original Set Aside:
Product Service Code: Q301 - MEDICAL- LABORATORY TESTING
NAICS Code: 621511 - Medical Laboratories
Place of Performance:
Intent to Sole Source 36C24221Q1395. This is an Intent to Sole Source, this is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to provide information based on this requirement. The Department of Veterans Affairs, Network Contracting Office 2, Regional Procurement Office - East, on behalf of the James J. Peters VA Medical Center located at 130 West Kingsbridge Road Bronx, NY 10468 intends to award a Firm-Fixed-Price sole source award to GENOMIC HEALTH,INC. for Polaris test for prostate cancer risk assessment.
The contractor shall provide all resources necessary to accomplish the deliverables described in the Price / Cost Sheet listed below for the Prolaris Test for Prostate Cancer Risk Assessment at the James J. Peters VA Medical Center. The vendor shall provide all necessary shipping/transport supplies free of charge. The specimen shall be returned to the Bronx, VAMC facility, free of charge. Prolaris is a genomic test that analyzes changes in 46 genes in prostate biopsy tissue. It generates a risk score to help predict the likelihood of disease progression in men with localized prostate cancer. Prolaris is intended to guide the decision regarding active surveillance without surgery or radiation for low- or intermediate-grade cancers vs. active treatment with immediate surgery or radiation therapy.
The risk of prostate cancer progression is currently evaluated based on the prostate-specific-antigen or PSA value, the Gleason score, and clinical factors. Prolaris is intended to increase the accuracy of these risk models by adding genetic information, and it provides an estimate of prostate cancer-specific mortality risk and whether the patient s cancer is less aggressive, similarly aggressive, or more aggressive than other patients in the risk group based only on clinical factors. The genetic information alone is used to generate a 10-point score, although the final risk assessment incorporates clinical factors as well as the genetic information.
The potential clinical benefit of Prolaris is that men could make a more informed, personalized decision regarding active surveillance vs. active treatment for localized prostate cancer. This is especially relevant for patients with a low or intermediate risk of disease progression based on clinical factors as calculated by one of the risk scores mentioned earlier.
The Oncotype DX-Prostate PLA 0047U is a mRNA, gene expression profiling by real-time RT-PCR of 17 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score.
Price / Cost Sheet:
PROLARIS TEST FOR PROSTATE CANCER RISK ASSESSMENT
GENOMIC HEALTH, INC. is the only known vendor able to provide the above service requirement. This procurement is being conducted in accordance with FAR 8.405-6 Limited Source Justification Approval and no other vendor will satisfy agency requirements. This notice of intent is not a request for competitive quotes. No solicitation documents are available and telephone requests will not be accepted. However, any firm that believes it can meet these requirements may give written notification to the Contracting Officer by September 3, 2021 at 10:00 am EST. supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. Information must be sent to the Contract Specialist, Janice Brooks by email to Janice.Brooks@va.gov. Telephone requests or inquiries will not be accepted. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, NCO 2 will proceed with the sole source negotiation with GENOMIC HEALTH, INC.
All responses are due no later than 10:00 EST on September 3, 2021.
Contracting Office Address
113 HOLLAND AVE
ALBANY , NY 12208
Secondary Point of Contact
Aug 26, 2021 12:55 pm EDTSpecial Notice (Original)