Competition The Federal Trade Commission today announced a settlement resolving its extensive investigation of Pfizer Inc.
FMI today announced that the company has entered into a broad partnership with Pfizer Inc. Pfizer currently has 10 FDA-approved oncology medicines that treat a diverse array of solid tumors and hematologic malignancies.
In addition, its oncology pipeline includes 17 assets in clinical development and 19 phase 3 studies. It also reports genomic biomarkers, such as microsatellite instability MSI and tumor mutational burden TMBthat can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and relevant clinical trial information.
As such, it is designed to help streamline companion diagnostic development, mitigate risk and advance targeted Pfizers company analysis development.
Currently FoundationOne CDx is FDA-approved as a CGP assay for all solid tumors and a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies.
The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types.
The final policy is expected to issue during the first quarter of following public comment on the preliminary NCD and an administrative period.
About FoundationOne CDx FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations indelsand copy number alterations CNAs in 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 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.
For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http: Story Continues About Foundation Medicine Foundation Medicine FMI 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. For more information, please visit http: All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.
View source version on businesswire.It said Innovative Medicines will bring in most of the company's revenue and has strong growth potential, due partially to an aging population that will create growing demand for new medicines.
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