CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA® (capmatinib) may be appropriate. TABRECTA® is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.
NSCLC accounts for approximately 85% of lung cancer diagnoses, 3 to 4% of which are associated with METex14. Today's approval adds to the number of therapies for which both of Foundation Medicine’s FDA-approved comprehensive genomic tests are listed as companion diagnostics. FoundationOne®CDx, Foundation Medicine’s tissue test, was approved as a companion diagnostic for TABRECTA® in May 2020.
“For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need,” said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. “This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for TABRECTA® and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient.”
Using a simple blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The test is now approved as a companion diagnostic for nine targeted therapies across four cancer types. TABRECTA® is the second therapy for which both of Foundation Medicine’s FDA-approved tests, FoundationOne CDx and FoundationOne Liquid CDx, are listed as companion diagnostics.
Additionally, as a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.
Foundation Medicine’s strategic collaboration with Novartis now includes four companion diagnostics for the Novartis portfolio of targeted oncology therapeutics.
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 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 Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
TABRECTA® is a trademark of Novartis.
Source: Foundation Medicine
- American Cancer Society. Key Statistics for Lung Cancer. Available at https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
- Data on file. Novartis Calculation. Kantar Health. CancerMPact: lung (non-small cell) stage IV incidence and newly recurrent. Updated December 15, 2018. my.khapps.com.