Q301--CareDx AlloSure Lab Test 07/01/2022 - 06/30/2023

The Sioux Falls, SD VA Contracting Department anticipates award of the following sole source procurement due to an Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2 exists.

A 12 month service contract shall be awarded on a sole source basis for molecular laboratory testing services for the Iowa City Health Care System (ICHCS), Pathology and Laboratory Medicine Service. The time period will be for one year.

This request is for molecular laboratory testing to include CareDx AlloSure Donor Derived Cell-Free DNA testing. The Iowa City VA is a major kidney transplant organ center for the VA, roughly performing one transplant a week for patients across the United States. The purpose of this test is to identify transplant rejection earlier compared to waiting on serum creatinine to start increasing which means there is more significant allograft damage to the patient. This AlloSure test by CareDx is the only non-invasive test that can assess organ health by directly measuring allograft injury. Testing for patients would occur at months 1, 3, 6, 9 and 12 post transplant.

Services will be available Monday through Friday 0800 1700 PST, excluding federal and contractor holidays. The contractor will provide specimen collection kits, requisitions, shipping supplies including prepaid shipping labels, specimen final result reports, direct data review, real time consultation and preliminary result reports when requested. The Contractor shall provide a mobile lab service for drawing patient samples at the patient s home at no additional cost to the ICVAHCS or patient. If requested, additional laboratory specimens pertinent to patient care shall also be drawn and delivered to the ICVAHCS at no additional cost. The ICVAHCS shall communicate what additional samples to draw and provide the contractor with copies of laboratory orders in a timely manner prior to the mobile lab arriving at the patient s home. AlloSure samples drawn at the patient s home shall be mailed directly to Contractor by the mobile lab service technician.

The base period of performance will be from 07/01/2022 to 06/30/2023 with an estimated value of $568,150.00. Awarded contract Y371A27ZEUM4 to CAREDX, INC. for 568150.00000000 on 2022-08-10.