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How to Order a Foundation Medicine Test
Solid Specimen Ordering Process
If you will be sending an FFPE block or unstained slides to Foundation Medicine for testing with FoundationOne®CDx or FoundationOne®Heme, please follow the instructions below:
Place a test order through your EMR system if enabled or order online by logging in or signing-up for a Foundation Medicine account. Orders can also be submitted via email or fax using our Test Requisition Form.
Complete the order form, provide any required attachments including Advanced Beneficiary Notice if needed, and submit. Some pathology labs require patient consent prior to releasing a specimen for testing, so providing us with a completed Specimen Release Consent Form up front can help avoid potential order delays.
Foundation Medicine will contact the pathologist if requested during the ordering process with instructions for sample procurement and shipment. If you will be arranging for specimen shipment yourself, please do so after submitting the order form. To request a Specimen Shipping Kit please contact client services or fill out our Order a Shipping Kit form below.
You will receive online or printed results typically 12 days or less from receipt of specimen for FoundationOne CDx.
Liquid Specimen Ordering Process
If you will be sending peripheral whole blood or bone marrow aspirate to Foundation Medicine for testing with FoundationOne®Liquid CDx or FoundationOne®Heme, please follow the instructions below:
Place a test order through your EMR if enabled or order online by logging in or signing-up for a Foundation Medicine account. Orders can also be submitted via email or fax using our Test Requisition Form.
Complete the order form, provide any required attachments including Advanced Beneficiary Notice if needed, and submit.
If collecting the sample in-office, request a Specimen Shipping Kit to your practice using the form below or by contacting our client services team. Mobile phlebotomy is also available for patients if preferred.
Once the kit arrives, collect the blood or bone marrow sample from your patient per the specimen instructions for the appropriate test and label tubes with two patient-specific identifiers.
Send the sample overnight to Foundation Medicine using the FedEx pack included in the kit.
You will receive online or printed results typically 10 days or less from receipt of specimen for FoundationOne Liquid CDx.
We know how important efficiency is for your clinical workflow. That’s why we’re partnering with EMR systems like Epic and OncoEMR to integrate our comprehensive genomic profiling (CGP) tests and our other testing services into your practices’ workflow. Once enabled, our EMR integrations allow providers to place orders for our CGP tests and receive and view test results directly within their existing workflow.
To learn more about our EMR integrations, please contact your Commercial Program Manager or reach out to our Client Services team at client.services@foundationmedicine.com or +1 (888) 988-3639.
Learn more about how online ordering, digital reporting, and our mobile application can help transform your genomic testing workflow.
Foundation Medicine is committed to helping patients access our testing services. Some commercial health plans such as Cigna and many BlueCross BlueShield plans offer coverage for Foundation Medicine testing services. Medicare covers FoundationOne CDx, FoundationOne Liquid CDx, and FoundationOne Heme for qualifying patients. FoundationOne CDx is also covered by TRICARE for qualifying patients. FoundationOne®Heme has limited commercial health plan coverage at this time.
Additional Ordering Options
Additional Ordering Options
Mobile Phlebotomy
Foundation Medicine offers in-home blood draw services through a mobile phlebotomy vendor to support broader access to FoundationOne Liquid CDx and FoundationOne Heme, at no additional cost. Mobile phlebotomy can be requested during the online ordering process or on our test requisition form. If requested, we will schedule a phlebotomist appointment directly with the patient and ship a kit to their home.
Resources
Mobile Phlebotomy Overview (Providers)Portfolio Reflex Option
We offer the option to automatically reflex between tissue and liquid sample types using our FDA-approved Portfolio of FoundationOne CDx and FoundationOne Liquid CDx. If the "Portfolio Reflex" option is selected during the online ordering process or on our Test Requisition Form, we will proceed with the initial CGP test selected and if the specimen does not meet the criteria for successful testing, we will automatically reflex to the other test and procure a new specimen. The failed test is not billed, and the successful test will be billed according to our standard practices.
Resources
Portfolio Reflex OverviewOrder a Kit
Order Foundation Medicine Specimen Shipping Kits to your practice.
Answers to Common Questions
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Foundation Medicine test reports can be accessed as soon as results are ready via our digital reporting portal or our mobile app – log in or sign up for a Foundation Medicine account or download our iOS app to obtain access. You can also receive access to results via secure email or request to have results faxed to you by reaching out to our Client Services team at client.services@foundationmedicine.com or by phone at +1 (888) 988-3639.
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To sign-up for a Foundation Medicine account to place orders and access patient results online, complete the sign-up form here. To request access to our other online applications, such as FoundationInsights®, FoundationSmartTrialsTM, or our online biopharma resources, please contact your local Foundation Medicine representative or our Client Services department at client.services@foundationmedicine.com.
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For issues related to Foundation Medicine online accounts, please contact App Support at app.support@foundationmedicine.com.
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To learn more about our EMR integrations, please contact your Commercial Program Manager or reach out to our Client Services team at client.services@foundationmedicine.com or +1 (888) 988-3639.
Additional Notes
FoundationOne Heme was developed and its performance characteristics determined by Foundation Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information on this laboratory developed test please see the Technical Specifications at foundationmedicine.com/f1h.
Important Safety Information
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FoundationOne CDx
FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDxLabel.com.
FoundationOne Liquid CDx
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.