Advances in genomic profiling continue to drive treatments for hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer. Over the past two-plus years, the US Food and Drug Administration (FDA) has approved three therapies (inavolisib, capivasertib, and elacestrant) for the treatment of HR+/HER2- metastatic breast cancer. Genomic testing is critical for identifying patients who may benefit from these targeted therapies.
Healthcare Provider Education
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Advanced Breast Cancer
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Decoded - Episode 3: Unlocking the Future of Breast Cancer Treatment: The PI3K Pathway & Precision Oncology
Dr. Mia Levy discusses some of the latest advancements in breast cancer treatment, including the role of PI3K pathway alterations and acquired alterations in ESR1 in identifying patients who may benefit from targeted therapy. We’ll explore how genomic testing is shaping the future of precision medicine and what these developments mean for both clinicians and patients.
Fusion Detection
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Genomic Testing to Identify Targetable Fusions in Liquid Biopsies
FoundationOne®Liquid CDx analyzes multiple classes of genomic alterations in DNA to identify genetic drivers of cancer, including point mutations, short insertions and deletions, rearrangements, gene deletions and amplifications. The real advantage of DNA as an analyte is that DNA is highly stable and can survive in tissue even if the tissue is archival and has been biopsied many years previously. Likewise, DNA does not degrade quickly in the blood. While RNA analysis can certainly add value to tissue biopsies, robust DNA sequencing still dominates in both tissue and liquid biopsies.
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Decoded – Episode 2: Genomic Testing to Identify Targetable Fusions in Liquid Biopsies
Hanna Tukachinsky, PhD, and Jessica Lee, MS, are co-authors on a recently published paper titled “Circulating Tumor DNA Enables Sensitive Detection of Actionable Gene Fusions and Rearrangements Across Cancer Types.” Listen to their latest research on fusion detection and what their findings mean for clinicians.
Circulating tumor DNA enables sensitive detection of actionable gene fusions and rearrangements across cancer types
See the highlights of this peer-reviewed article from Clinical Cancer Research in a brief animated publication summary. Watch the video to learn how the frequency of detection of pathogenic rearrangements was comparable in liquid biopsies with a ctDNA tumor fraction 1%+ to those detected in tissue biopsies. ctDNA tumor fraction also helps differentiate between truncal driver rearrangements and subclonal events that may represent acquired resistance or other tumor heterogeneity.
ctDNA Tumor Fraction
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ctDNA Tumor Fraction Matters When Interpreting Liquid Biopsy Test Results
While oncologists increasingly use liquid biopsies for genomic testing, many still have concerns that a negative result from liquid biopsy may not be meaningful enough to direct clinical decision making. This concern can be mitigated by Foundation Medicine’s new circulating tumor DNA tumor fraction which improves confidence in the meaning of a negative result from liquid biopsies.
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Decoded – Episode 1: ctDNA Tumor Fraction Matters When Interpreting Liquid Biopsy Test Results
Lincoln Pasquina, PhD, Director of Clinical Development at Foundation Medicine, explains how physicians can leverage Foundation Medicine’s ctDNA tumor fraction to improve clinical care. ctDNA tumor fraction is a measure of how much ctDNA is measured in an individual liquid biopsy.
Measurement of ctDNA tumor fraction identifies informative negative liquid biopsy results and informs value of tissue confirmation
See the highlights of this peer-reviewed article from Clinical Cancer Research in a brief animated publication summary. Watch the video to learn how Foundation Medicine's ctDNA tumor fraction can distinguish whether tumor-derived DNA is present in a liquid biopsy sample. Using the ctDNA tumor fraction threshold of 1%+, providers can have increased confidence in negative results on a liquid biopsy.
Meet Our Experts
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Dr. Tukachinsky
Hanna Tukachinsky is a Sr. Translational Scientist in Clinical Development and joined Foundation Medicine, Inc. in 2020. Dr. Tukachinsky is interested in molecular mechanisms that drive oncogenesis in different tissues and in emerging biomarkers for therapeutics. She received her BA from Columbia University and PhD from Harvard Medical School.
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Dr. Pasquina
Lincoln Pasquina is Director of Clinical Development at Foundation Medicine, Inc. Dr. Pasquina oversees evidence generation, planning, and execution for comprehensive genomic profiling assays with a focus on tissue-agnostic monitoring. He earned his BS from MIT and PhD from Harvard Medical School.
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Jessica Lee
Jessica Lee joined Foundation Medicine, Inc. in 2018 and is currently a Data Scientist in the Clinical Development Department. She earned a BS in Computational Neuroscience and an MS in Biomedical Engineering from Carnegie Mellon University.
Additional Notes
FoundationOne®CDx and FoundationOne®Liquid CDx are qualitative next-generation sequencing based in vitro diagnostic tests for advanced cancer patients with solid tumors and are for prescription use only. FoundationOne CDx utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures. FoundationOne Liquid CDx analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes. The tests are companion diagnostics to identify patients who may benefit from treatment with specific therapies in accordance with the 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 tests 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 testing with FoundationOne CDx when archival tissue is not available which may pose a risk. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are tested with FoundationOne Liquid CDx and 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 important risk information, please visit www.F1CDxLabel.com and www.F1LCDxLabel.com.