Q301--Natera Signatera ctDNA Analysis for RIVAL Research Study

Regional Procurement Office (RPO) - East intends to negotiate on a sole source basis with Natera, Inc., to perform their perform circulating tumor DNA (ctDNA) analysis on approximately 40 patients with locally advanced non-small cell lung cancer (NSCLC) for a VA-funded research study by the VA Ann Arbor Healthcare System.

STATEMENT OF WORK

A. GENERAL INFORMATION

Requirement:

The supplies and services requested by this contract are to support the following VA-funded research study: RIVAL: Repositioning Immunotherapy in VeterAns with Lung Cancer. One of the study objectives is to evaluate whether circulating tumor DNA (ctDNA), which is present in Veterans with locally advanced non-small cell lung cancer (NSCLC) will decrease following administration of chemotherapy plus immunotherapy (chemoIO) and whether the clearance of ctDNA can be used to predict progression-free survival. Signatera is a highly sensitive and personalized assay used to measure ctDNA that is owned by Natera. Participants in this study have a baseline sample that is sent to Natera through a separate contract between the National Precision Oncology Program (NPOP) and Natera. The RIVAL study proposes to collect samples for two additional time points: 9 weeks and 20 weeks post chemoimmunotherapy treatment. These samples would also be sent to Natera for ctDNA analysis.

Natera will perform analysis on approximately 40 samples (20 patients x 2 time points.

Sites participating in RIVAL

a. VA Ann Arbor Healthcare System

(Lead site responsible for payment of samples collected at each site)

2215 Fuller Rd. Ann Arbor MI, 48105

PI: Dr. Nithya Ramnath

Louis Stokes Cleveland VA Medical Center

10701 E Blvd. Cleveland OH, 44106

PI: Dr. Charles Nock

Durham VA Medical Center

507 Fulton St. Durham NC, 27705

PI: Dr. Michael Kelley

Michael E. DeBakey VA Medical Center

2002 Holcombe Blvd. Houston TX, 77030

PI: Dr. Daniel Shin

Omaha VA Medical Center

4101 Woolworth Ave. Omaha NE, 68105

PI: Dr. Apar Ganti

Richmond VA Medical Center

1970 Roanoke Blvd. Salem VA, 24153

PI: Dr. Bhaumik Patel

West Haven VA Medical Center

950 Campbell Ave. West Haven CT, 06516

PI: Dr. Michal Rose

Scope and Methodology:

Blood for ctDNA analysis will be collected at specified time points as per the clinical protocol and shipped to Natera as per company shipping guidelines. Natera will be responsible for: 1) processing blood for ctDNA, 2) performing quality control of sequence data, 3) comparing ctDNA between baseline and 2 subsequent timepoints, and 4) reporting of results from ctDNA data. Natera has significant experience with the ctDNA platform (has CAP and CLIA approved platform) and is well suited to take on the analysis challenges associated with this proposal.

Period of Performance: The period of performance (POP) shall be Base Year plus 2 option years. Each POP shall be 12 months in length.

Place of Performance: Performance of the contract will take place at the Contractor s facility. Results will be sent to VA Ann Arbor Healthcare System

Type of Contract: Firm Fixed Price

Natera is a leader in the ctDNA testing sphere. Their test for ctDNA, called Signatera, has been characterized in more than 100 peer-reviewed publications and has been tested on more than 200,000 patients. Signatera is a molecular residual disease assay (MRD) and a positive Signatera result predicts relapse with overall positive predictive value of greater than 98%. For this reason, Signatera is used to help clinicians make informed decisions about a patient s treatment plan. The laboratory performing the Signatera test is both accredited by the College of American Pathologists (CAP) and certified by the Clinical Laboratory Improvement Amendments (CLIA), ensuring the accuracy and reliability of results.

The primary reason why no other supplier can be used is due to the fact that the baseline sample for the participants in the RIVAL study will be analyzed using the Signatera assay via a separate contract between Natera and NPOP. It is essential to use the same platform to compare subsequent samples to ensure that ctDNA is being detected in the sample with the same sensitivity and specificity. Using a different platform would compromise the analysis between the baseline sample and the 9- and 20-week samples and would make the data meaningless.

The Signatera assay was named in the awarded VA Merit, which underwent scientific peer-review and administrative review by the VA Office of Research and Development. Subsequently, the protocol which also named Signatera as the assay for ctDNA testing was approved by the Central IRB and by the Research and Development Committees of all VA sites involved in the study.

This notice of intent is not a request for competitive proposals. Any responsible sources who wish to identify their interest and capability to provide this equipment or equipment that is compatible must notify this Contracting Officer at Millicent.Covert@va.gov NLT Friday, January 31, 2025, by 11:59 AM EST. Telephone responses will not be accepted. Upon receipt of the interested parties' notification, the Contracting Officer will determine whether to conduct a competitive procurement or proceed with sole source negotiations.