Providing Greater Confidence in Fusion Detection
Fusions are rare alterations in cancer but are top-of-mind for many oncologists. This is due, in part, to the abundance of personalized, U.S. Food and Drug Administration (FDA) approved therapies that have emerged in recent years to target fusions—particularly in cancers with multiple actionable fusion drivers such as non-small cell lung cancer (NSCLC). At Foundation Medicine, we are so excited to announce a new addition to our tissue testing portfolio that uses RNA sequencing to help us identify even more of these cases for greater impact on patient care.
The oncology landscape has changed dramatically in the last decade, as precision medicine has transformed our understanding of and ability to treat cancer. To fulfill our mission to make genomic profiling indispensable in cancer care, Foundation Medicine continues to innovate. We have developed and expanded our portfolio of tests and services – from pioneering the development of new cancer biomarkers to enabling testing for more patients through two FDA approved comprehensive genomic profiling (CGP) tests, monitoring capabilities, and more.
All these advancements demonstrate our dedication to never losing sight of how healthcare providers’ needs are evolving as new information and therapies become available to treat cancer. This dedication is a key driver behind the development and launch of our new RNA test offering, FoundationOne®RNA1.
Introducing FoundationOne®RNA
FoundationOne RNA is a tissue-based RNA sequencing test for the detection of cancer-related gene fusions and rearrangements that can be added to orders of FoundationOne®CDx2, our high-quality tissue-based CGP DNA test. The addition of FoundationOne RNA provides healthcare providers with another layer of sophisticated fusion detection through RNA sequencing.
By offering both DNA and RNA testing options for fusion detection, physicians and our research partners can rely on Foundation Medicine for greater confidence in fusion detection. When we designed both of our DNA-based, FDA-approved CGP tests, we were extremely intentional about enhancing their ability to detect fusions. We optimized our DNA bait set to specifically sequence intronic regions of 34 genes we know are prone to fusions. For example, FoundationOne CDx is the only tissue-based test with FDA-approved companion diagnostic claims to detect ROS1, NTRK, ALK, FGFR2, and RET fusions across multiple tumor types3; FoundationOne®Liquid CDx4 is the only FDA-approved blood-based CGP test to analyze over 300 genes including detection of rearrangements in 8 genes.
However, while we are confident in our DNA-based CGP tests’ ability to detect actionable fusions, there has been significant advancement in the range of options available for fusion detection through RNA sequencing. Adding FoundationOne RNA to our testing portfolio highlights our commitment to providing truly comprehensive diagnostic tools so that health care providers have all the necessary genomic information to best treat their patients.
Testing With Ease & Actionability
It's important to note that, in our view, the word comprehensive does not necessarily mean expansion without reason or testing without actionability. We designed our testing technology to enable both DNA and RNA extraction from a single sample, utilizing a coextraction method where DNA and RNA can be isolated, avoiding additional tissue requirements which would prohibit its use for some patients. FoundationOne RNA reports detected fusions across all 318 genes it sequences, focusing our efforts on delivering the key information that is relevant to treatment decision-making.
Furthermore, the RNA fusion results are incorporated into a single comprehensive report along with the DNA results, enhancing clinical usability. This report can be integrated into all major electronic medical record (EMR) systems across the U.S.
The expanding testing landscape is, at first glance, a more complex place than ever when it comes to choosing a comprehensive option for patients. We are excited to help health care teams navigate these complexities by expanding the clinically relevant fusions they can detect through a highly efficient workflow. With the combination of FoundationOne CDx and FoundationOne RNA, Foundation Medicine provides fusion detection done right.
References
1FoundationOne®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.
2FoundationOne®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
3Data on File, Foundation Medicine, Inc., 2024; 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.
4FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as 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 other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation 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.