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

Foundation Medicine, Inc. has recently introduced FoundationOne®RNA, a sophisticated RNA sequencing test designed to identify cancer-related gene fusions across a spectrum of 318 genes. This tissue-based test is now available in the United States for clinical use, having previously been accessible for research and investigational purposes since September 2023. FoundationOne RNA is particularly advantageous for identifying fusions in various solid tumors, including non-small cell lung cancer (NSCLC), pancreatic cancer, cholangiocarcinoma, sarcoma, thyroid cancer, and bladder cancer.

The introduction of FoundationOne RNA broadens the scope of Foundation Medicine's existing genomic profiling tools. These tools include the FoundationOne®Liquid CDx, a blood-based comprehensive genomic profiling test, and FoundationOne®Heme, which is tailored for hematological malignancies. Additionally, Foundation Medicine offers circulating tumor DNA monitoring assays such as FoundationOne®Tracker and FoundationOne®Monitor, the latter currently being available for research purposes.

Dr. Mia Levy, Chief Medical Officer of Foundation Medicine, highlighted the significance of this new RNA test. According to Dr. Levy, while DNA sequencing with FoundationOne CDx can uncover many gene fusions, the addition of RNA sequencing with FoundationOne RNA provides an enhanced detection capability for fusions across 318 genes. She noted the growing number of therapies approved for targeting these fusions, especially for NSCLC. By employing both DNA and RNA testing methods, Foundation Medicine aims to deliver precise and prompt results, even considering the inherent instability of RNA. This dual approach is designed to offer physicians and research partners increased confidence in fusion detection.

The results from both FoundationOne RNA and FoundationOne CDx are compiled into a unified report, offering clinicians comprehensive insights on detected genetic alterations, potential therapies, and relevant clinical trials. This integrated report is intended to aid physicians in making informed decisions about targeted therapeutic options for each patient.

Dr. Courtney Granville, Chief Scientific Officer at GO2 for Lung Cancer, emphasized the value of RNA-based fusion detection in treatment planning for lung cancer patients. Dr. Granville expressed enthusiasm about the new testing option from Foundation Medicine, which, alongside the DNA tissue-based test, can uncover more actionable fusions and provide essential information for patient care decisions.

Foundation Medicine employs an efficient extraction method for FoundationOne CDx, enabling the isolation of both DNA and RNA from a single Formalin-Fixed Paraffin-Embedded (FFPE) sample. This approach minimizes the amount of tissue required without affecting the turnaround time for test results.

Foundation Medicine continues to be a leader in molecular profiling for cancer. The company collaborates with a broad array of partners within the cancer community, aiming to set high standards for quality, scientific excellence, and regulatory leadership. Their advanced understanding of cancer biology supports physicians in making well-informed treatment decisions and aids researchers in developing new medications. Foundation Medicine's goal is to empower their partners to take action and provide precision cancer care to more patients globally.

In summary, FoundationOne®RNA represents a significant advancement in cancer fusion detection, complementing the existing DNA-based tools offered by Foundation Medicine. By providing integrated and detailed reports, the company strives to enhance clinical decision-making and improve outcomes for cancer patients.