Summary: Foundation Medicine has launched a tissue-based RNA sequencing test for clinical use, which detects cancer-related fusions across 318 genes and is designed to aid in targeted therapeutic selection for various cancers.


  1. The new RNA test complements Foundation Medicine’s existing genomic profiling tests, including DNA-based tests and liquid biopsy options, enhancing the detection of cancer-related genetic fusions.
  2. FoundationOne RNA is now available for clinical use after being introduced for research purposes in 2023, offering comprehensive fusion detection in solid tumors like NSCLC and pancreatic cancer.
  3. Combining results from FoundationOne RNA and FoundationOne CDx in a single report provides physicians with actionable insights for targeted therapies and clinical trial options, improving personalized cancer treatment.

Foundation Medicine 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, the company says. 

This test was made available to researchers in September 2023 for research and for investigational use, and is now being launched for clinical use.

Tissue-Based RNA Sequencing Test

Foundation Medicine’s new RNA test expands the company’s portfolio of high-quality tests and services, which includes a blood-based comprehensive genomic profiling test, FoundationOne Liquid CDx, and a test for hematological malignancies, FoundationOne Heme. Foundation Medicine also offers circulating tumor DNA monitoring assays, including clinically available and tissue-informed FoundationOne Tracker, and tissue-naïve FoundationOne Monitor, which is currently available for research use, the company says.

“While DNA sequencing with optimized targeting using FoundationOne CDx can detect many fusions, RNA sequencing with FoundationOne RNA can provide another layer of sophisticated fusion detection in 318 genes,” says Mia Levy, MD, PhD, Chief Medical Officer, Foundation Medicine. “In recent years, there have been an abundance of newly approved therapies to target fusions, many of which are for NSCLC. By offering both DNA and RNA testing options for fusion detection and delivering fast and accurate results considering the instability of RNA, physicians and our research partners can rely on Foundation Medicine for greater confidence in fusion detection.”

Further reading: FDA Approves FoundationOne CDx as Companion Diagnostic for EGFR Therapeutics

Targeted Therapy

Results from FoundationOne RNA and FoundationOne CDx are included together in a single report, designed to provide physicians with clinically actionable information from both tests to inform targeted therapeutic selection. The report includes detected alterations, potential therapies, and available clinical trials for physicians to consider for each unique patient.

“Fusion detection using RNA can be an extremely valuable component of treatment planning for patients living with lung cancer,” said Courtney Granville, PhD, MSPH, Chief Scientific Officer, GO2 for Lung Cancer (GO2). “We are excited that Foundation Medicine has introduced this additional testing option, that in addition to its DNA tissue-based test, can help detect more actionable fusions and provide doctors with more information to inform their care decisions for patients.”

Foundation Medicine uses a coextraction method for FoundationOne CDx, the only tissue comprehensive genomic profiling test approved to detect fusions with DNA alone, where DNA and RNA can be isolated from a single Formalin-Fixed Paraffin-Embedded (FFPE) sample to minimize tissue volume requirements with no impact on turnaround time.

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

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