Foundation Medicine launches RNA sequencing test, FoundationOne®RNA, in the US

Foundation Medicine, Inc., 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.

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.

“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.”

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.


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