CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that it has entered a strategic collaboration with Merck KGaA, Darmstadt, Germany to develop FoundationOne®Liquid CDx and FoundationOne®CDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments. This new agreement builds on the data solutions partnership Merck KGaA, Darmstadt, Germany and Foundation Medicine entered in 2020 to help accelerate the development of novel targeted therapies, individually and in combination.
If the companion diagnostic indications are approved, based on tissue availability and the presentation of individual patients, oncologists will be able to use FoundationOne CDx or FoundationOne Liquid CDx to identify those with genomic alterations that may make them eligible for a specific targeted therapy.
“We’re proud to announce this new phase of our partnership with Merck KGaA, Darmstadt, Germany, and continue building on our shared commitment to advance personalized treatment options for patients,” said Jason Adams, vice president of biopharma enterprise partnerships at Foundation Medicine. “We look forward to ongoing collaboration as they leverage our portfolio of end-to-end solutions to generate meaningful evidence, help optimize therapy development, and deliver companion diagnostic solutions using our tissue and liquid comprehensive genomic profiling tests.”
Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. The company’s robust suite of data and assay solutions support biopharmaceutical organizations as they work to design and deliver new targeted therapies, starting with biomarker discovery and clinical trial enrollment through to companion diagnostic development and commercialization.
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 Twitter and LinkedIn.
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 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.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
Source: Foundation Medicine
Contacts
Foundation Medicine:
Erin Smith, 262-914-2779
newsroom@foundationmedicine.com