FoundationOne®RNA

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INTRODUCTION

A combined approach to fusion detection

Introducing FoundationOne®RNA: Now available to add to your FoundationOne®CDx order. This combined testing approach with both DNA + RNA offers a reliable fusion detection strategy unlike any other; the proven fusion detection of FoundationOne CDx, now with the added confidence of RNA when you want it.

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OVERVIEW

What is FoundationOne RNA?

FoundationOne RNA is an RNA sequencing test that detects fusions across 318 genes for all solid tumors. It adds to the proven DNA fusion detection of FoundationOne CDx:

FoundationOne CDx

  • The only tissue-based CGP test FDA-approved to detect fusions with DNA alone.1
  • The only tissue-based test with FDA-approved companion diagnostic claims to detect ROS1, NTRK, ALK, FGFR2, and RET fusions across multiple tumor types.2

FoundationOne RNA

  • An added layer of fusion detection across 318 cancer-associated genes, including all fusions for therapy selection in solid tumors.3

How it Works 

Cancer Type

  • All Solid Tumors

Sample Type

  • No additional sample needed beyond FoundationOne CDx requirements: 10 unstained slides OR: 1 block + 1 H&E slide

Patient Benefits

Actionable results, added patient impact

While rare, fusions are important, and identifying an actionable fusion can be extremely impactful for a patient. This is due, in part, to the increasing number of personalized therapies available that target fusions—particularly in NSCLC. Consider adding FoundationOne RNA to your FoundationOne CDx order in these instances:

1. When treating any solid tumor type where RNA sequencing is recommended by guidelines, e.g. NSCLC.4

2. For any solid tumor type with a high prevalence of actionable fusions where added confidence in detection is desired.

How It Works

DNA + RNA: Two tests that act as one

Foundation Medicine's combined approach with FoundationOne CDx + FoundationOne RNA helps providers to make accurate and timely clinical decisions. The comprehensiveness you want—without complicating your clinical workflow.

1 order

FoundationOne RNA is easy to add to your FoundationOne CDx order—
a click in your portal or EMR is all it takes

1 sample

No additional specimen beyond what’s required for FoundationOne CDx

1  report

DNA + RNA results combined

 

How to Order

Resources

Read more about FoundationOne®RNA

FAQs
Resources
Press Release

Foundation Medicine Launches RNA Sequencing Test, FoundationOne®RNA, in the U.S.

Foundation Medicine, Inc., today announced the U.S. launch of FoundationOne®RNA, a tissue -based RNA sequencing test for the detection of cancer-related fusions across 318 genes.FoundationOne RNA enables reporting of fusions in all solid tumors and may be valuable for detecting fusions in certain cancers, such as non-small cell lung cancer (NSCLC), pancreatic cancer, cholangiocarcinoma, sarcoma, thyroid cancer, and bladder cancer. This test was made available to researchers in September 2023 for research and for investigational use, and today is being launched for clinical use.

Press Release

How to Order

Add FoundationOne RNA to your FoundationOne CDx order

When placing an order for FoundationOne CDx in the Foundation Medicine online portal or in your EMR, simply click to add FoundationOne RNA. Foundation Medicine will complete both tests together.

No additional kit needed for FoundationOne RNA. The same sample provided in the FoundationOne CDx kit is used.

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Additional Notes

FoundationOne®RNA is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne RNA has not been cleared or approved by the U.S. Food and Drug Administration. FoundationOne RNA is a test for solid tumors which utilizes RNA sequencing to interrogate 318 cancer-related genes to capture gene fusions and rearrangements. A negative result does not rule out the presence of an alteration.  Genomic findings are not prescriptive or conclusive for labeled use of any specific therapeutic product.

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.

1. U.S. Food & Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Updated December 21, 2023. Accessed April 16, 2024. 

2. U.S. Food & Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Updated December 21, 2023. Accessed April 16, 2024.

3. Data on File, Foundation Medicine, Inc., 2024.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V. 2023.