Federal Supply Schedule 36F79723D0005

DEPARTMENT OF VETERANS AFFAIRS

Federal Supply Schedule Service

Authorized Federal Supply Schedule Price List

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Medical Laboratory Testing and Analysis Services

FSC Group 621 Part II

FSC Class: Q301

Contract Number: 36F79723D0005

Contract Period: October 15, 2022 – September 30, 2027

For more information on ordering from Federal Supply Schedules go to the GSA Schedules page at GSA.gov.

BIODESIX, INC.

2970 Wilderness Place, Suite 100

Boulder, CO 80301 Phone #: 303-417-0500

Fax: 303-417-9700 www.biodesix.com

Primary Contract Administrator: Lelarae Murray, Market Access Analyst II

Alternate Contract Administrator: Robin Harper Cowie, CFO

Unique Entity ID (UEI) Number: RPULDMFCWF4 Data Universal Number System (DUNS) Number: 809047215

Central Contractor Registration (CCR) Cage Code: 6T0H7

Business Size: Small

“Prices Shown Herein are Net (discount deducted)” http://www.biodesix.com/

BIODESIX, INC., (303) 417-0500, www.biodesix.com

Customer Information:

1. Table of awarded special item number(s) with appropriate cross reference to item descriptions and awarded prices:

SIN: 621-208 …………………………………. Page(s) 5 thru 9

2. Maximum order: $100,000.00

3. Minimum order: None

4. Geographic coverage (delivery area): All 50 States to include District of Columbia, Alaska, Hawaii, and Puerto Rico

5. Point(s) of production (testing site locations; city, county, and State or foreign country):

Biodesix, Inc., 8960 Commerce Dr, BLDG 6, De Soto, KS 66018

Biodesix, Inc., 2970 Wilderness Pl, Ste 100, Boulder, CO 80301‐5438

6. Discount from list prices or statement of net price: Prices shown herein are Net (discount deducted)

7. Quantity Discounts: None

8a. Prompt Payment Terms (Note: Prompt payment terms must be followed by the statement "Information for

Ordering Offices: Prompt payment terms cannot be negotiated out of the contractual agreement in exchange for other concessions.": None

8b. Notification that Government purchase cards are accepted at or below: Accepts Government credit cards

9. Foreign items (list items by country of origin): Not Applicable

10a. Time of Delivery (for sampling kits): Routine Test: N/A – Complex Test: 3-6 days

10b. Expedited delivery (for sampling kits): Not Applicable

10c. Overnight and 2-day Delivery (for sampling kits): Not Applicable

11a. Testing/specimen pick up/request procedures:

- Testing is drawn on‐site at the ordering facility and sent directly to the laboratory via FedEx. Test Request forms are sent back to the laboratory with the specimen kit.

O 3rd party shipping notifications are used to anticipate specimen arrival.

- Test Request forms can also be received via secure email, fax, or portal request when a draw is done in the patient’s home.

o Home Phlebotomy test requests may come in prior to receipt of specimen kit.

O Home Phlebotomy draws are tracked via capture of the shipping tracking number at time of the draw.

11b. Specimen Collection and Handling Requirements (Price list must indicate whether patient demographic information is available upon request in either hardcopy or electronic format, listing any e-mail addresses or web links necessary to obtain the Requirements):

Pickup of specimens

- Specimens are collected using the Biodesix® Specimen collection Kit (SCK) and shipped via approved courier to ensure maximum integrity during collection, transport, and receipt at Biodesix.

- Test specimens are placed in the FedEx packaging according to provided instructions and comply with 3 barrier biohazard shipping requirements.

- Specimen tracking protocol for specimen transportation, including sample record, shipping method, and proposed carrier (including chain of custody protocol, when required)

- All kit packages are shipped via FedEx Priority Overnight.

- All kits include a prepaid FedEx UN3373 envelope labeled with destination laboratory address affixed.

Analysis protocol

- Laboratory personnel will only open and inspect one kit at a time to avoid unnecessary mixing of specimens and TRFs.

- Specimens are accessioned in Salesforce to ensure chain of custody from receipt of the specimen through

TRR generation, up to the final destruction of the specimen.

- Each specimen must meet acceptance criteria prior to processing and/or reporting of test results. The laboratory will process all specimens of sufficient quantity and quality to a minimum of biological stability.

- Samples are received and accessioned by Laboratory personnel per the procedures listed below.

11c. Hours of Operation, as proposed by the contractor in Document 02 - Vendor Response Document and agreed upon by the contract award (this should detail the hours of operation upon which the turnaround times are based):

- Monday - Friday (7am - 6pm) MST

11d. Turnaround Time (TAT) Table, as proposed by the contractor in Document 02 - Vendor Response

Document and agreed upon by the contract award (in lieu of #11 in I-FSS-600):

- Turn Around Times: 6 days (after receipt of order)

- Assay Schedule - Monday – Friday

11e. Test Results Delivery:

- Laboratory personnel transmit reviewed data to generate Test Result Report documents and notify Test processing personnel for delivery.

- Results are delivered via fax, secure email (encrypted) or portal account, based on the ordering physician’s original method of request. All TRR documents are confirmed as delivered by Test Processing personnel.

- Email: ClientServices@biodesix.com

- Website: portal.biodesix.com

12a. Ordering address(es):

Biodesix, Inc.

2790 Wilderness Pl, Ste 100 Boulder, CO 80301 Phone #: 866-432-5930

- Email: ClientServices@biodesix.com

12b. Ordering Procedures:

Notification by ordering activity:

- Sales Team onboards new customer providing training, contact resources, kit inventory and answers to any questions the site may have.

- Established sites may request kits via email or phone. Kits are sent to site FedEx Priority Overnight. The Test Request form, collection information and shipping instructions are included in the kit.

- Email: ClientServices@biodesix.com

- Phone #: 866-432-5930

13. Payment address(es):

Biodesix, Inc.

PO Box 732569 Dallas, TX 75373‐2569

14. Export packing charges, if applicable: Not Applicable

15. Terms and conditions of any other services (if applicable): Not Applicable

16. List of participating dealers (if applicable): Not Applicable

17. If applicable, indicate that Section 508 compliance information is available on Electronic and Information

Technology (EIT) supplies and services and show where full details can be found (e.g., contractor’s website or other location). The EIT standards can be found at www.Section508.gov/ : Not Applicable

18. Data Universal Number System (DUNS) number: 809047215

19. Notification regarding registration in System for Award Management (SAM) database: Yes, registered

20. Use of Subcontractors (i.e. Test Send Outs): Not Applicable

21. LOINC Code(s): 220 & 310

Exhibit(s):

(A) FSS Product Price List

Exhibit (A)

Contractor: Biodesix, Inc.

Contract Number: 36F79723D0005

Contract Period: October 15, 2022 through September 30, 2027 Prices Effective: 10/15/2022

FSS Price List

SIN# TEST

ORDER

CODE

TEST NAME AND DESCRIPTION CPT

CODE

UOI FSS PRICE

621-208 XL2N Nodify XL2 ‐ Immunology ‐ The intended use of the test is to assist physicians in the management of lung nodules by identifying those lung nodules with a high probability of being benign. The test is used for patients 40 years or older, with nodules between 8 and 30mm in diameter, and a pre‐test cancer risk of 50% or less. Nodify XL2 is an

LDT.

Assay Methodology: Liquid Chromatography Mass Spectrometry. Liquid chromatography (LC) separates compounds from a sample prior to analysis. Mass spectrometry (MS) functions through: ionization, separation, detection, and analysis. When combined with LC, the potential for MS to identify and quantitate analytes of interest increases dramatically.

0080U Each $3,555.56

621-208 ECDT Nodify CDT ‐ Immunology ‐ Nodify CDT test is a blood‐ based lung nodule test designed to help identify low to moderate risk patients with an incidental lung nodule that is likely malignant. The test is intended for patients at least 40 years of age with an incidental lung nodule between 8‐30mm, no history of cancer, and a pre‐test risk of malignancy of 65% or less calculated using the solitary pulmonary nodule calculator. Nodify CDT is an LDT.

Assay Methodology: ELISA (enzyme‐linked immunosorbent assay) is a plate‐based assay technique designed for detecting and quantifying soluble substances such as peptides, proteins, antibodies, and hormones. Also described as EIA (enzyme immunoassay).

81599 Each $514.01

621-208 VERI VeriStrat ‐ Immunology ‐ VeriStrat® is a blood‐based predictive and prognostic proteomic test for patients with advanced non‐small cell lung cancer (NSCLC) who test negative for EGFR mutations (EGFR wild‐type) or whose EGFR mutation status is unknown. VeriStrat identifies the host patient response to the tumor activity by measuring acute phase reactant proteins in the blood.

VeriStrat provides prognostic value as it assesses disease aggressiveness, classifying patients as either VeriStrat Good (VSGood) or VeriStrat Poor (VSPoor). VeriStrat Poor signature correlates with a more aggressive disease and poor prognosis; VSGood signature correlates with a more favorable prognosis. VeriStrat is proven to be predictive in retrospective and a prospective Phase III study, assisting physicians in selecting between single‐agent treatment options. Patients with a VSGood signature are proven to have similar overall survival when treated with chemotherapy or EGFR‐TKI therapy (i.e. erlotinib), and patients with a VSPoor signature have been proven to receive little to no benefit from EGFR‐TKI therapy, and therefore should not be offered the drug. VeriStrat is an

LDT.

Assay Methodology: Matrix‐assisted laser desorption/ionization (MALDI) is an ionization technique that is a top‐down proteomics approach for analyzing intact proteins in serum and plasma.

Proprietary high‐density matrix‐assisted laser absorption/ionization time‐of‐flight (MALDI‐ToF) mass spectrometry (MS) technology helps to overcome the limitations of conventional MALDI‐ToF and other mass spectrometry methods by producing highly sensitive, stable, and reproducible data.

81538 Each $2,376.77

621-208 NGS GeneStrat NGS ‐ Immunology ‐ Test targets 52 genes across multiple cancer types, including lung, colorectal, breast, pancreatic, thyroid, and others. GeneStrat NGS is an LDT.

Assay Methodology: Next generation sequencing (NGS) is a high throughput, massively parallel sequencing technique that can generate large amounts of clinically relevant genomic data from blood or tissue.

81455 Each $3,541.41

621-208 GSEGFR GeneStrat EGFR ‐ Immunology ‐ The GeneStrat Epidermal Growth Factor Receptor (EGFR) test is a highly accurate, blood‐based mutation analysis that offers clinically actionable, genetic information for patients with nonsmall cell lung cancer (NSCLC). Using a blood sample from a simple blood draw, the test identifies whether a patient has a driver mutation in order to assist physicians in prescribing targeted therapies, without the need for a tissue biopsy. Understanding whether anomalies in this gene are present allows physicians to consider use of targeted therapies for their patients. The test offers reliable detection of guideline‐recommended

81235 Each $180.32 mutations, provides results within 72 hours of sample shipment to the Biodesix laboratory, and is concordant to tissue‐based mutation testing. GeneStrat EGFR is an LDT.

Assay Methodology: Droplet Digital PCR is a highly sensitive, cost-effective, and fast technology to detect gene mutations in plasma cell free DNA and RNA, tissue, cells, and other specimen types.

621-208 GSBRAF GeneStrat BRAF ‐ Immunology ‐ The GeneStrat B‐Raf (BRAF) test is a highly accurate, blood‐based mutation analysis that offers clinically actionable, genetic information for patients with non‐small cell lung cancer (NSCLC) and other cancers where targeted therapy is a treatment option (e.g., melanoma). With a simple blood draw, the test identifies whether a patient has a driver mutation in order to assist physicians in prescribing targeted therapies, without the need for a tissue biopsy. Understanding whether anomalies in this gene are present allows physicians to consider use of targeted therapies for their patients. The test offers reliable detection of guideline‐recommended mutations, provides results within 72 hours of sample shipment to the Biodesix laboratory and is concordant to tissue‐based mutation testing. GeneStrat BRAF is an LDT.

Assay Methodology: Droplet Digital PCR is a highly sensitive, cost effective, and fast technology to detect gene mutations in plasma cell free DNA and RNA, tissue, cells, and other specimen types.

81210 Each $97.44

621-208 GSKRAS GeneStrat KRAS ‐ Immunology ‐ The GeneStrat Kirsten rat sarcoma oncogene homolog (KRAS) test is a highly accurate, blood‐based mutation analysis that offers clinically actionable, genetic information for patients with non‐small cell lung cancer (NSCLC) and other cancers where targeted therapy is a treatment option (e.g., colorectal cancer). With a simple blood draw, the test identifies whether a patient has a driver mutation in order to assist physicians in prescribing targeted therapies, without the need for a tissue biopsy.

Understanding whether anomalies in this gene are present allows physicians to consider use of radiation therapy for their patients. The test offers reliable detection of guideline recommended mutations, provides results within 72 hours of sample shipment to the Biodesix laboratory, and is concordant to tissue‐based mutation testing. GeneStrat KRAS is an LDT.

Assay Methodology: Droplet Digital PCR is a highly sensitive, cost effective, and fast technology to detect gene mutations in plasma cell free DNA and RNA, tissue, cells, and other specimen types.

81275 Each $107.36

621-208 GSALK GeneStrat ALK ‐ Immunology ‐ The GeneStrat echinoderm microtubule-associated protein‐like 4 anaplastic lymphoma kinase (EML4‐ALK) test is a highly accurate, blood‐based mutation analysis that offers clinically actionable, genetic information for patients with non‐ small cell lung cancer (NSCLC). With a simple blood draw, the test identifies whether a patient has a gene rearrangement in order to assist physicians in prescribing targeted therapies, without the need for a tissue biopsy. Understanding whether rearrangements in the gene are present allows physicians to consider use of targeted therapies for their patients. The test offers reliable detection of guideline‐recommended rearrangements, provides results within 72 hours of sample shipment to the Biodesix laboratory. GeneStrat ALK is an LDT.

Assay Methodology: Droplet Digital PCR is a highly sensitive, cost-effective, and fast technology to detect gene mutations in plasma cell free DNA and RNA, tissue, cells, and other specimen types.

81401 Each $76.11

621-208 GSRET GeneStrat RET ‐ Immunology ‐ The GeneStrat rearranged during transfection mutation (RET) fusions test is a highly accurate, blood‐based mutation analysis that offers clinically actionable, genetic information for patients with non‐small cell lung cancer (NSCLC). With a simple blood draw, the test identifies whether a patient has a fusion rearrangement in order to assist physicians in prescribing targeted therapies, without the need for a tissue biopsy.

Understanding whether anomalies in this gene fusions are present allows physicians to consider use of targeted therapies for their patients. The test offers reliable detection of guideline recommended fusion rearrangements, provides results within 72 hours of sample shipment to the Biodesix laboratory, and is concordant to tissue based mutation testing. GeneStrat RET is an LDT.

Assay Methodology: Droplet Digital PCR is a highly sensitive, cost-effective, and fast technology to detect gene mutations in plasma cell free DNA and RNA, tissue, cells, and other specimen types.

81404 Each $152.69

621-208 GSROS GeneStrat ROS 1 ‐ Immunology ‐ The GeneStrat Proto‐ oncogene tyrosineprotein kinase (ROS‐1) test is a highly accurate, blood‐based mutation analysis that offers clinically actionable, genetic information for patients with non‐small cell lung cancer (NSCLC). With a simple blood draw, the test identifies whether a patient has a fusion rearrangement in order to assist physicians in prescribing targeted therapies, without the need for a tissue biopsy. Understanding whether anomalies in this gene fusions are present allows physicians to consider

81479 Each $323.23 use of targeted therapies for their patients. The test offers reliable detection of guideline‐recommended fusion rearrangements, provides results within 72 hours of sample shipment to the Biodesix laboratory, and is concordant to tissue‐based mutation testing. GeneStrat ROS1 is an LDT.

Assay Methodology: Droplet Digital PCR is a highly sensitive, cost-effective, and fast technology to detect gene mutations in plasma cell free DNA and RNA, tissue, cells, and other specimen types.