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

FoundationOne^®RNA can now be added to FoundationOne^®CDx orders for even greater confidence in fusion detection

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.

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.

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

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.

About FoundationOne^®RNA

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.

About FoundationOne^®CDx

FoundationOne^®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. 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 a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

About FoundationOne^®Liquid CDx

FoundationOne^®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is 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. Patients being considered for eligibility for therapy based on detection of NTRK1/2/3 and ROS1 fusions should only be tested if tissue is unavailable. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration 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.

About FoundationOne^®Tracker

FoundationOne^®Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. FoundationOne Tracker is performed exclusively as a laboratory service and has not been cleared or approved by the U.S. Food and Drug Administration. For technical specifications, please visit FoundationMedicine.com.

About FoundationOne^®Monitor

FoundationOne^®Monitor is a tissue-naïve circulating tumor DNA (ctDNA) monitoring test currently available for research use in retrospective studies. FoundationOne Monitor provides access to Foundation Medicine’s ctDNA tumor fraction, which is a determination of the amount of circulating tumor DNA as a fraction of total cell free DNA in a blood sample that accounts for aneuploidy, variant allele frequency, fragment length information, clonal hematopoiesis predictions and known tumor-associated alterations. The test offers molecular response insights to complement standard imaging in early-phase clinical research and has capabilities for monitoring individual variants or assessing resistance to therapy across more than 300 genes. FoundationOne Monitor is currently in development for clinical use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240521109894/en/