LSJ MDx Health Final signed.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C259-20-AP-2919 J&A Tracking Number: 2020-08-05T04:02:39

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 19, 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111

Organizational Activities: PURCHASE REQUEST (2237):

VA Montana Health Care System, 1892 Williams St, Fort TBD – Funding memo provided Harrison, MT 59636

VA Eastern Colorado Health Care System, 1700 TBD – Funding memo provided N Wheeling Street, Aurora, CO 80045

VA Western Colorado Health Care System, 2121 North Ave, TBD – Funding memo provided Grand Junction, CO 81501

Oklahoma City VA Health Care System, 921 NE 13th St, TBD – Funding memo provided Oklahoma City, OK 73104

VA Salt Lake City Health Care System, 500 Foothill Blvd, TBD – Funding memo provided Salt Lake City, UT 84148

(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). The department of Veterans Affairs requires MDx genetic prostate cancer testing services in support of the above listed VISN 19 VA Medical Centers.

The proposed procurement will be a sole source, single award BPA. This award will be a firm fixed-price BPA funded by yearly task order by each VA facility. The period of performance will be October 1, 2020 through September 30, 2021, followed by four (4) option years.

Order against: FSS Contract Number: V797D-70066

Name of Proposed Contractor: MDx Health, Inc.

Street Address: 15279 Alton Pkwy, Ste 100

City, State, Zip: Irvine, CA 92618

Phone: 813-951-1112

(3) Description of Supplies or Services:

The estimated value of the proposed action is $539,944.76 for 5 years. The estimated value of the base year is $106,505.10.

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The procurement shall provide specialized genetic testing service to the Pathology and Laboratory Medicine Services for MDx Cancer testing on previously negative prostate biopsy specimens from men who are considered at risk for prostate cancer. This service is critical to the support of the prognosis and treatment of a VA patient with regard to prostate cancer through the identification of specific genetic markers. This supports the mission of the VA to provide timely, accurate and appropriate pathology services in support of patient care. These tests are only available from MDx Health. The tests to be covered under this BPA are:

ConfirmMDx (81551) at $1845.45 per test

SelectMDx (81479) at $404.04 per test

The requirement shall contain a one-year base period, followed by four (4) one-year Government option years.

Base Year – October 1, 2020 – September 30, 2021

Option Year 1 - October 1, 2021 – September 30, 2022

Option Year 2 - October 1, 2022 – September 30, 2023

Option Year 3 - October 1, 2023 – September 30, 2024

Option Year 4 - October 1, 2024 – September 30, 2025

(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.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

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;

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.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

The ConfirmMDx is a tissue based testing solution which addresses false-negative biopsy concerns, helping urologists “Rule-out” otherwise cancer-free men from undergoing unnecessary repeat biopsies and screening procedures, helping to reduce complications, VHAPM Part 808.405-6 Limiting Sources Page 3 of 5

Revision 02 Eff Date: 02/21/2020 patient anxiety and excessive healthcare expenses associated with these procedures.

The NPV for ConfirmMDx is 96%. For men with an initial negative biopsy, independently published clinical studies have shown that the ConfirmMDx test is the most significant, independent predictor of patient outcome relative to other available clinical factors such as age, PSA and DRE results. Incorporating ConfirmMDx for Prostate Cancer into clinical practice can substantially reduce the number of unnecessary repeat biopsies and can aid Urologists with patient management decisions regarding the need for repeat biopsy with the identification of low-risk patients testing negative for DNA hypermethylation. The test uses 3 genes which are run 48 different times to produce the result you will get. There are currently no other tests on the market that provide the results the ConfirmMDx test does. This test is proprietary to MDx Health in both its analyzer/supplies as well as its testing methodology and algorithms.

The SelectMDx is a liquid biopsy test which helps Urologists identify patients at increased risk of aggressive disease, thereby aiding in the selection of men for prostate cancer, thus reducing the number of initial biopsies. SelectMDx provides the likelihood of detecting prostate cancer upon biopsy, and the probability for high-grade vs low-grade disease, with an AUC of 0.89 (95% CI: 0.86-0.92). SelectMDx for Prostate Cancer is a reverse transcription PCR (RT-PCR) assay performed on post-DRE (digital rectal examination), first-void urine specimens from patients with clinical risk factors for prostate cancer, who are being considered for biopsy. The test measures the mRNA levels of the DLX1 and HOXC6 biomarkers, using KLK3 expression as internal reference, to aid in patient selection for prostate biopsy. Higher expression levels of DLX1 and HOXC6 mRNA are associated with an increased probability for high-grade (Gleason score (GS) ≥ 7) prostate cancer. There are currently no other tests on the market that provide the results the SelectMDx test does. This test is proprietary to MDx Health in both its analyzer/supplies as well as its testing methodology and algorithms.

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.

(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:

This requirement is for tests that are both necessary for patient care but are also proprietary to MDx Health. There are currently no alternatives to using MDx Health because they are the only ones who can provide the required tests. Tests from any other vendor would not fully meet the requirement, which would lead to increased risk to patient care. The best value to the Government is to award to MDx Health under a limited source justification as the tests they offer have been in place within VISN 19 facilities for the past 5 years and are proprietary to MDx Health. There are no other tests currently on the market that will fulfill the requirement. The pricing for each required test is listed in the contractor’s

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FSS schedule and has previously been determined by GSA to be Fair and Reasonable. Additional discounts based on volume will be requested.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted:

Sources Sought notice 36C25920Q0479 was posted to FBO on 06/24/20 and closed on 07/10/20. It received no responses other than confirmation from MDx Health. In addition, a search in VetBiz was conducted using NAICS code 621511, the states of Montana, Wyoming, Colorado, Utah, and Oklahoma along with the key words “Cancer Testing”. It yielded 15 SDVOSB/VOSB companies. Phone calls and/or emails to 8 of them either got no response or the company verified they could not provide the MDx Health tests necessary for this requirement. The other 7 were not testing labs and appeared to be consulting type vendors that would act as a pass through to testing labs.

(7) Any Other Facts Supporting the Justification:

MDx Health provided a letter explaining the proprietary nature of the required tests. There are no other authorized vendors for these tests at this time. The specific genetic markers with regard to prostate cancer are offered only through the MDx Health proprietary tests.

(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:

All future requirements for specialized genetic prostate cancer testing will be competed to the greatest extent practicable, including the consideration of the Veterans First program as well as all other possible small business set-asides. The market will be evaluated to determine if the MDx Health tests are still the best fit for the requirement, as well as if additional vendors offer the same types of tests.

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(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. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

Tania Urenda Medical Technologist Path / Lab

NAME TITLE SERVICE LINE/SECTION

Rocky Mountain Regional VA Medical Center

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

_____ _______07/28/20_______________________

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Ian Boettcher – Contracting Officer NCO 19__________________________

NAME AND TITLE FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Albert Williams

NCO 19

Division Chief

Tania A. Urenda 301366 Digitally signed by Tania A. Urenda 301366 Date: 2020.08.07 09:04:04 -06'00'

Ian N. Boettcher 665900

Digitally signed by Ian N.

Boettcher 665900 Date: 2020.08.07 09:10:18 -06'00'

VHAECHWilliA Typewritten Text 18 Aug 2020