Test your advanced breast cancer patients for ESR1 mutations before disease progression at no added cost.*
Guardant Health and AstraZeneca have partnered to help make ESR1 testing more accessible to patients.
Through the Sponsored Testing Program (STP), eligible patients can receive ESR1 testing at no cost, reducing potential financial barriers. Using Guardant360 CDx, the fastest, comprehensive FDA-approved liquid biopsy, clinicians can identify actionable biomarkers to connect patients with targeted therapies—including those with ESR1 mutations.
For healthcare providers (HCPs) who typically order Guardant Health testing through an electronic health record (EHR), please note that STP orders must be submitted either via the test requisition form on this website or through the Guardant Health Portal.
To qualify for this sponsored test, the HCP attests that:
The patient has histologically confirmed HR‑positive, HER2‑negative locally advanced breast cancer and is on first‑line endocrine treatment
The patient is on CDK4/6 and aromatase inhibitor (AI) therapy with no evidence of progression
Testing of the patient’s sample is consistent with the Guardant Assay CDx label
The patient's insurance does not cover repeat NGS testing prior to radiological progression
This test will be used for ESR1 monitoring
The ESR1 test is clinically appropriate and medically necessary for the patient
For assistance, contact our support team at 855-698-8887.
Sponsored by
How to Order Guardant360 CDx for Sponsored Testing in 3 Simple Steps
Step 1 Complete Order Form
Option A: Download and complete the Sponsored Testing Program Test Requisition Form available on this website.
Option B: Complete the online ordering form through the Sponsored Testing Program Guardant Health Portal.
Step 2 Prepare and Ship Sample
Fill out all barcode labels, including patient/subject ID, date of birth, and collection date.
Place the tubes in the protective sleeve and Guardant Health blood collection kit, then seal the kit inside the preprinted FedEx Clinical Pak.
Schedule a FedEx pick-up for convenient same-day or next-day shipping.
Step 3 Review Test Result
Access and review the test results directly through the Guardant Health Portal once available.
Routine monitoring for ESR1m emergence is critical to identify ESR1 in metastatic breast cancer patients.
Liquid biopsy offers comprehensive molecular profiling through a simple blood draw.
Tissue testing has unique challenges in ER+ metastatic breast cancer (mBC) due to tumor evolution and heterogeneity.4 ctDNA-based technology overcomes recurring problems in the clinical evaluation of mBC.
Liquid biopsy is a fast, minimally-invasive tool to capture tumor heterogeneity across metastatic disease.5
~30% of mBC patients have bone-only metastases, making tissue biopsy challenging.7
Circulating tumor DNA (ctDNA) is released into the blood as cancer cells die and is a rich source of genomic information about the tumor cells.6
Due to the acquired nature of ESR1 mutations, national guidelines:
Recommend testing with liquid ctDNA at each progression8
Do not recommend testing with primary archived tissue8
Guardant360 CDx is an easy-to-interpret report with matched therapies This information is provided as a professional service and
has not been reviewed or approved by the FDA.
Ordering and Resources
First FDA-approved comprehensive liquid biopsy.
Actionable results in 5 days.‡
Only requires 2 tubes of blood.
For questions about the Sponsored Testing Program, call 855–698–8887.
*Sponsored Testing Program for Guardant360 CDx Terms and Conditions
The Guardant360 CDx Sponsored Testing Program (the “Program”) is offered by AstraZeneca Pharmaceuticals (AstraZeneca) in order to address patient barriers to clinically appropriate, provider-prescribed testing. Through the Program, AstraZeneca, through an arrangement with Guardant Health, Inc. (Guardant Health), makes Guardant360 CDx test available at no-charge for certain eligible patients with metastatic breast cancer.
Patients must meet all of the following criteria to be eligible for the Program (collectively, the “Eligibility Criteria”):
The patient has histologically confirmed HR‑positive, HER2‑negative locally advanced breast cancer and is on first‑line endocrine treatment
The patient is on CDK4/6 and aromatase inhibitor (AI) therapy with no evidence of progression
Testing of the patient’s sample is consistent with the Guardant Assay CDx label
The patient's insurance does not cover repeat NGS testing prior to radiological progression
This test will be used for ESR1 monitoring
The ESR1 test is clinically appropriate and medically necessary for the patient
The Program covers the cost of one Guardant360 CDx test per eligible patient per completed Program Test Requisition Form. To participate in the Program, the provider must submit to Guardant Health an attestation that confirms that: (i) the patient satisfies the Program Eligibility Criteria; (ii) the provider believes that Guardant360 CDx is clinically appropriate and medically necessary for the patient; (iii) the provider is not seeking reimbursement for Guardan360 CDx or other services provided in connection with Guardant360 CDx test; and (iv) the provider has obtained consent necessary to comply with applicable law.
The Program is open to any patient who meets the Eligibility Criteria, regardless of insurance status. There is no obligation to recommend, purchase, order, prescribe, promote, administer, use, or support any AstraZeneca, Guardant Health, or other third-party product or service to participate in the Program.
The Program does not cover any additional services associated with the patient’s treatment, including the cost of blood collection. No patient, provider, or payer, including government payers, are billed for the Program. Providers may not seek reimbursement from any patient or third party payer (including commercial health plans and government health care programs) for Guardant360 CDx or other services provided in connection with the Program.
AstraZeneca does not receive patient or provider identifiable information in connection with the Program.
AstraZeneca retains the right to amend or rescind the Program at any time. While AstraZeneca provides financial support for the Program, tests and services are performed by Guardant Health. AstraZeneca assumes no liability and provides no warranties for the testing services provided by Guardant Health.
The Program is available only in the United States in the 50 states and the District of Columbia.
†Guardant Health data on file.
References: 1. Turner N, Huang-Bartlett C, Kalinsky K, et al. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol. 2023;19(8):559-573. doi:10.2217/fon-2022-1196. 2. Bidard FC, Hardy-Bessard AC, Dalenc F, et al. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022;23(11):1367-1377. doi:10.1016/S1470-2045(22)00555-1. 3. Clatot F, Perdrix A, Beaussire L, et al. Risk of early progression according to circulating ESR1 mutation, CA-15.3 and cfDNA increases under first-line anti-aromatase treatment in metastatic breast cancer. Breast Cancer Res. 2020;22(1):56. Published 2020 May 28. doi:10.1186/s13058-020-01290-x. 4. Wedam SB, Beaver JA, Amiri-Kordestani L, et al. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018;36(12):1225-1231. doi:10.1200/JCO.2017.74.6917. 5. Bettegowda C, Sausen M, Leary RJ, et al. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014;6(224):224ra24. doi:10.1126/scitranslmed.3007094. 6. Lanman RB, Mortimer SA, Zill OA, et al. Analytical and Clinical Validation of a Digital Sequencing Panel for Quantitative, Highly Accurate Evaluation of Cell-Free Circulating Tumor DNA. PLoS One. 2015;10(10):e0140712. Published 2015 Oct 16. doi:10.1371/journal.pone.0140712. 7. Hilton JF, Amir E, Hopkins S, et al. Acquisition of metastatic tissue from patients with bone metastases from breast cancer. Breast Cancer Res Treat. 2011;129(3):761-765. doi:10.1007/s10549-010-1264-6. 8. Burstein HJ, DeMichele A, Somerfield MR, Henry NL; Biomarker Testing and Endocrine and Targeted Therapy in Metastatic Breast Cancer Expert Panels. Testing for ESR1 Mutations to Guide Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2023;41(18):3423-3425. doi:10.1200/JCO.23.00638.