FSS-621-II - Mdxhealth, Inc. - V797D70066

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Federal Supply Schedule V797D70066
Contract number
V797D70066
Issued by

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This Federal Supply Schedule (FSS) Price List details the contract between the Department of Veterans Affairs and MDXHealth, Inc. for medical laboratory testing services, specifically focused on prostate cancer diagnostic tests. The contract (V797D-70066) is valid from February 1, 2017, to January 31, 2027, and covers three primary molecular diagnostic tests: ConfirmMDx for Prostate Cancer (priced at $1,845.45 per test), SelectMDx for Prostate Cancer (priced at $404.04 per test), and Oncotype Dx GPS Prostate (priced at $3,192.93 per test).

The tests utilize advanced molecular diagnostic techniques including methylation-specific polymerase chain reaction, reverse transcription PCR, and gene expression profiling to detect and assess prostate cancer risks. MDXHealth is registered in the System for Award Management and is classified as a small business. The contract enables VA facilities to order these specialized tests with a maximum order limit of $100,000, covering all 48 contiguous U.S. states, Washington D.C., Alaska, Hawaii, and Puerto Rico. Test results are typically delivered within 10-16 days via fax, secure web portal, or U.S. mail.

Mdxhealth, Inc. Pricelist and/or Vendor Terms and Conditions for V797D70066, a Federal Supply Schedule awarded to Mdxhealth, Inc., under Medical Laboratory Testing and Analysis Services (FSS-621-II)

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The Department of Veterans Affairs - FSS Authorized Federal Supply Schedule Price List

On-line access to contract ordering information, terms and conditions, up-to-date pricing, and the option to create an electronic delivery order are available through GSA Advantage!, a menu-driven database system. The INTERNET address for GSA Advantage is: www.GSAAdvantage.gov

FSC Group 621, Part II, Medical Laboratory Testing & Analysis Services, FSC Q301 For more information on ordering Federal Supply Schedules click on the FSS Schedules button at www.fss.gsa.gov.

Contractor: MDXHealth, Inc.

Contract Number: V797D-70066

Contract Period: 2/1/2017 - 1/31/2027 Incorporating Modifications P00010 for new CPT Code

15279 Alton Parkway Suite 100 Irvine, CA 92618

Phone # 949-812-6979 Fax # 949-788-0014 Web Site: www.mdxhealth.com

Small Business

CUSTOMER INFORMATION:

1a. Awarded Special Item Numbers: 621-200 Anatomic Pathology

2. Maximum Order: $100,000

3. Minimum Order: One Test

4. Geographic Coverage: All 48 contiguous U.S. States, Washington D.C., Alaska, Hawaii, and, Puerto Rico

5. Point of Production:

Testing Site Locations

Test Place of Performance ConfirmMDx - ConfirmMDx for Prostate Cancer SelectMDx - SelectMDx for Prostate Cancer

MDxHealth, Inc 15279 Alton Parkway, Suite 100 Irvine, CA 92618 Orange County

Oncotype Dx-Prostate Genomic Health, Inc., wholly owned subsidiary of Exact Sciences Corp.

301 Penobscot Dr.

Redwood City CA 94063-4700 San Mateo County

6. Prices herein are net, discount deducted.

7. Quantity Discounts: None

8. Prompt Payment Terms: Net 30 days http://www.gsaadvantage.gov/ http://www.fss.gsa.gov/

9. Government purchase cards are accepted below and above the micro-purchase threshold.

10. Foreign Items: N/A

11a. Delivery Time for test supplies: Fed Ex 6 Days ARO

11b. Expedited Delivery Time for test supplies: FedEx 2 day

11c. Testing/Specimen pickup/request procedures:

• The doctor's office requests a test by mailing in a Specimen Transport Kit that includes the Specimen & the

Test Requisition Form.

• Obtain an MDxHealth Specimen Transport Kit. Kits are either left with the doctor's office by the Sales Rep & or delivered to the office.

• Follow the instructions included in the Kit for preparing specimen

• Place the MDxHealth Specimen Transport Kit in the pre-labeled FedEx Clinical Pak & seal the Clinical Pak. A

FedEx Clinical Pak is included in every Kit.

• Contact FedEx for pickup

• For internal record keeping, document the FedEx tracking number.

For any questions, contact MDxHealth Client Services at 866-259-5644.

11d. Hours of Operation/Assay Schedule:

11e. Holiday Closures

MDxHealth is closed for the following holidays:

New Year Day President Day Memorial Day Independence Day Labor Day Thanksgiving Day - Thursday and Friday Christmas Holidays - December 24 and 25

Genomic Health, Inc. is closed for the following holidays:

New Year Day Martin Luther King Day President Day Memorial Day Independence Day Labor Day Thanksgiving Day - Thursday and Friday Christmas Holidays - December 24 and 25

11f. Test Results Maximum Turn Around Time

Test TAT ConfirmMDx - ConfirmMDx for Prostate Cancer SelectMDx - SelectMDx for Prostate Cancer

10 Days ARO; Specialized test cannot be performed in less than 10 days

Oncotype Dx-Prostate 16 Days ARO; Specialized test cannot be performed in less than 16 days

11g. Expedited Test Results: These tests cannot be expedited

DAY Sun Mon Tues Wed Thurs Fri Sat

Hours of Operation

N/A 6:00am-9:00 pm PST

6:00am- 9:00 pm PST

6:00am- 9:00 pm PST

6:00am- 9:00 pm PST

6:00am- 9:00 pm PST

N/A

11h. Test Results Delivery:

1. Test Results via FAX:

• Contact Name: Client Services

• Phone Number: 866-259-5644

• Email Address: client.services@mdxhealth.com

2. Test Results via Web Site Log In:

• Test Results vie WebSite. Web address for login: https://mdxhealth.kiteworks.com

• Contact Name: Client Services

• Phone Number: 866-259-5644

• Email Address: client.services@mdxhealth.com

3. Results via U.S. Mail

• If requested a hard copy of the results are mailed to the client address. Most results are sent to the office via Fax or through the secure portal

12. F.O.B. Points: FOB Destination to the 50 U.S. States, Washington D.C., and Puerto Rico

13a. Ordering Address:

MDxHealth

13b. Ordering Procedures: For services, the ordering procedures and information on Blanket Purchase Agreements

(BPA’s) can be found in the Federal Acquisition Regulation (FAR) 8.405-2 and 8.405-3 on the FSA/FSS Schedule homepage (http://www.gsa.gov/bpa).

14. Payment Address:

MDxHealth

15. Warranty/Exchange Goods: N/A

16. Export Packing Charges: N/A

17. Terms and conditions of Gov’t Purchase Card acceptance: Credit cards accepted below, equal to, and above MPT of with no maximum.

18. Terms & conditions of rental, maintenance, & repair: N/A

19. Terms and conditions of Installation/Training: N/A

20. Terms and conditions of repair parts indicated, date of parts price lists and any discounts from list prices: N/A

20a. Terms and conditions of other services:

21. List of service and distribution points: N/A

22. List of participating dealers: N/A

23. Preventive maintenance: N/A

24a. Special attributes: N/A

24b. Section 508 EIT supplies and services: N/A

25. SAM UEI: LQGYDJJ9K8Q6

26. System for Award Management: Yes, registered.

FSS PRICE LIST

Contractor: MDXHealth, Inc.

Contract Number: V797D-70066 Contract Period: 2-1-2017 to 1-31-2027

Prices Effective: 12/20/2022

SIN# TEST ORDER

CODE

TEST DESCRIPTION TESTS

INCLUDED

CPT CODE UOM All Inclusive

FSS PRICE with

IFF

621-200 ConfirmMDx ConfirmMDx for Prostate Cancer Description: Test is used to: detect methylation in genes associated with prostate cancer. The test is used for men with an abnormal digital rectal exam (DRE) and/or elevated PSA and normal histology to identify men who have underlying occult cancer for re-biopsy and those patients who may avoid unnecessary repeat biopsies. Specimen Type: Prostate Tissue Assay Method: Methylation-Specific Polymerase chain reaction (MS-PCR or MSP) – Real time

Single Test 81551 X 1 EA $1,845.45

621-200 SelectMDx SelectMDx for Prostate Cancer Description: The SelectMDX test helps identify patients at increased risk for aggressive disease, aiding in the selection prostate biopsy. The test measures the mRNA levels of the DLX1 and HOXC6 biomarkers, using KLK3 expression as internal reference. Higher expression levels of DLX1 and HOXC6 mRNA are associated with an increased probability for high-grade prostate cancer.

Specimen Type: Liquid Biopsy Urine collection Assay Method: Reverse transcription PCR (RT-PCR) Assay

Single Test PLA code 0339U

EA $404.04

621-200 Oncotype Dx GPS Prostate

Test Description: Oncology Prostate, mRNA gene expression profiling by real-time PCR of 17 genes (12 content and 5 housekeeping) utilizing formalin fixed paraffin embedded tissue, algorithm reported as a risk score. Specimen Type: Tissue Assay Method: Profiling by Real-Time PCR of genes to provide a risk score of prostate cancer

Single Test PLA Code 0047U

EA $3,192.93

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