Provider FAQs

FoundationOne RNA is a laboratory developed test (LDT) that uses hybrid capture-based next generation sequencing (NGS) for the detection of cancer-related gene fusions and rearrangements from RNA across 318 genes for all solid tumors.

FoundationOne RNA can be added to orders of FoundationOne®CDx, to provide additional insights and confidence in fusion detection beyond the proven DNA-based fusion detection provided by FoundationOne CDx.

FoundationOne RNA must be added at the time that a FoundationOne CDx order is placed. FoundationOne RNA is only available for digital ordering, in the Foundation Medicine online portal, or in EMRs. FoundationOne RNA cannot be ordered through a paper Test Requisition Form.

Foundation Medicine offers the option for providers to add FoundationOne RNA testing to FoundationOne CDx orders for all solid tumors. However, for providers who wish to add RNA for added confidence in fusion detection, they may consider the following scenarios:

• Any solid tumor type where RNA sequencing is recommended by guidelines, including NSCLC.

• Any solid tumor type with a high prevalence of actionable fusions where added confidence in detection is desired.

When adding FoundationOne RNA to FoundationOne CDx orders, no additional sample or kit is needed beyond what is required for FoundationOne CDx testing. FoundationOne RNA utilizes RNA extracted through a coextraction method using the same sample provided in the FoundationOne CDx kit.

ctDNA is released by tumor cells and collected by liquid biopsy. ctDNA allows biomarker testing and therapy selection when tissue biopsy is not available, or tissue is limited.1

Early information from ctDNA, through treatment response monitoring, could inform approaches to treatment by helping stratify patients with a high risk of resistance who might be candidates for escalation, versus those with a low risk of recurrence who might benefit from de-escalation to reduce risk of toxicities.2

Detectable ctDNA following surgery or neoadjuvant treatment for early-stage cancers, known as molecular residual disease, is associated with a high risk of recurrence and could provide valuable risk stratification information for making adjuvant treatment decisions.3

References:

1 Rolfo et al. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021. doi: 10.1016/j.jtho.2021.06.017.

2 Dasari A, Morris VK, Allegra CJ, et al. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020;17(12):757-770. doi:10.1038/s41571-020-0392-0

3 Tie J et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer [published correction appears in JAMA Oncol. 2019 Dec 1;5(12):1811]. JAMA Oncol. 2019;5(12):1710-1717. doi:10.1001/jamaoncol.2019.3616

FoundationOne Tracker can be used for all advanced solid tumor diagnoses, including late-stage disease and metastasis, as long as there is adequate ctDNA shed.

FoundationOne Tracker can only be ordered through the Foundation Medicine Online Portal. FoundationOne Tracker can be ordered with a new baseline or as a single timepoint using an existing baseline test. Each timepoint must be ordered separately.

Historical FoundationOne CDx results issued prior to August 20th, 2019 will require updated FoundationOne CDx testing.

  • Historical results prior to August 20th, 2019 will require updated FoundationOne CDx testing.

  • Historical results between August 20th, 2019 and June 30th, 2021, are eligible as baselines for FoundationOne®Tracker but require a request for re-running the Genomic Analysis pipeline, which could lead to an amended report.

  • Historical results from July 1st, 2021 and later require no additional steps.

Comprehensive genomic profiling (CGP) is a method of testing tumors that uses next-generation sequencing (NGS) to detect the four main classes of alterations known to drive cancer growth: base substitutions, insertions and deletions, copy number alterations (CNAs), and rearrangements or fusions. This testing can be performed on multiple specimen types including FFPE tissue, peripheral whole blood, bone marrow aspirate or extracted nucleic acid. CGP helps you better predict response or resistance to targeted- and immuno- therapies for more advanced cancer patients as compared to traditional molecular testing.

Single biomarker testing identifies alterations that are confined to a single gene, potentially missing clinically relevant mutations in additional genes. Gene hotspot testing may test multiple genes at a time but is confined to commonly altered regions within those genes, resulting in potentially missing other clinically relevant classes of alterations. Comprehensive genomic profiling detects the four main classes of genomic alterations across a broader panel of genes, oftentimes hundreds.

Foundation Medicine tests look at more than 300 cancer-related genes:

Explore our gene coverage by test

*FoundationOne Liquid CDx is FDA-approved to report substitutions and indels in 311 genes, including rearrangements and copy number losses only in ALK and BRCA1/2 and copy number alterations in BRCA1/2 and ERBB2 (HER2). Comprehensive results across all 324 genes are reported as a laboratory professional service which is not reviewed or approved by the FDA.

Online Ordering: Order online by signing up for a Foundation Medicine account.

Email Ordering: To order by email, download and complete a test requisition form, along with attachments (pathology report, insurance information, and Advance Beneficiary Notice if required), and email to client.services@foundationmedicine.com.

You can also place an order via fax by sending a completed test requisition form along with attachments to 617-418-2290. Visit our Order a Test page to order specimen shipping kits for your practice.

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.

All Foundation Medicine comprehensive genomic profiling tests are run in CAP Accredited and CLIA Certified labs. View our certification documents here.

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.

For issues related to Foundation Medicine online accounts, please contact App Support at app.support@foundationmedicine.com.

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.

Patient out-of-pocket costs will vary depending on your insurance. For those with out-of-pocket costs, financial assistance may be available.* Anyone can apply at any time to see if they qualify. Complete an online form or this PDF application.

Or talk to a Client Services team member at:

Phone: 888.988.3639 Email: client.services@foundationmedicine.com

*Financial assistance is only available for tests ordered within the U.S. and its territories.

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