" FSA " Approved Foundation Medicine's Companion Diagnostic Test For Solid Tumors, Making It The First Of Its Kind On The U.s. Market.
Cambridge, Mass.--(business Wire)--foundation Medicine, Inc. ('NASDAQ FMI') Today Announced That The U.s. Food And Drug Administration ('FDA') Approved Foundationone Cdx, The Company’s Comprehensive Companion Diagnostic Test For Solid Tumors. Foundationone Cdx Is Intended For Use By Health Care Professionals To Help Inform Cancer Treatment Management In Accordance With Professional Guidelines For Patients With Solid Tumors. The First And Only Fda-approved Test Of Its Kind For All Solid Tumors, Foundationone Cdx Is A Diagnostic Test That Acts As:
Access To Important Genomic Information Is A Critical Step In Being Able To Offer Innovative And Targeted Treatment Options.
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A Comprehensive Companion Diagnostic To Identify Patients Who May Benefit From Treatment With Specific Fda-approved Targeted Therapies;
A Comprehensive Genomic Profiling ('CGP') Test That Includes Genomic Biomarkers To Help Inform The Use Of Other Targeted Oncology Therapies, Including Immunotherapies;
A Tool For Physicians That Identifies Patient Opportunities For Clinical Trial Participation; And,
An Fda-approved Platform For Companion Diagnostic Development For Biopharma Companies Developing Precision Therapeutics.
Foundationone Cdx Assesses All Classes Of Genomic Alterations In 331 Genes Known To Drive Cancer Growth, Providing Potentially Actionable Information To Help Guide Treatment Decisions. It Is Also Indicated As A Companion Diagnostic For Patients With Certain Types Of Non-Small Cell Lung Cancer ('NSCLC'), Melanoma, Colorectal Cancer, Ovarian Cancer Or Breast Cancer To Identify Those Patients Who May Benefit From Treatment With One Of 09 On-label Targeted Therapies, Including 11 Therapies Currently Approved As First-line Therapy For Their Respective Indications. Foundationone Cdx Also Reports Genomic Biomarkers, Such As Microsatellite Instability ('MSI') And Tumor Mutational Burden ('TMB'), That Can Help Inform The Use Of Immunotherapies; Genomic Alterations In Other Genes Relevant To Patient Management; And, Relevant Clinical Trial Information.
Based On Previous Cgp Testing Conducted By Foundation Medicine, It Is Estimated That Approximately 1 In 3 Patients Across Five Common Advanced Cancers Are Expected To Match With An Fda Approved Therapy.1 The Number Of Matched On-label Therapies Indicated On Foundationone Cdx Is Expected To Increase Over Time As Foundation Medicine And Its Biopharma Partners Pursue Fda Approval For Additional Companion Diagnostics On The Platform. Today, Approximately 43% Of New Cancer Drugs In Development Are Projected To Have A Companion Biomarker.2
Concurrent With Fda Approval, The Centers For Medicare And Medicaid Services ('CMS') Issued A Preliminary National Coverage Determination ('NCD') For Foundationone Cdx. 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 2018 Following Public Comment Of The Preliminary Ncd And An Administrative Period.
Today We Know That Many People With Cancer Do Not Receive Biomarker Testing, Let Alone The Comprehensive Genomic Testing They Need To Be Efficiently Matched To The Best Therapeutic Option,” Said Andrea Ferris, President And Ceo Of Lungevity Foundation. “this Fda Approval Means That, In One Test, Patients Can Access Therapies Where Companion Diagnostics Have Been Established For Their Cancer While Getting A Broad Tumor Profile That Can Identify The Therapies And Clinical Trials They Could Most Benefit From. Along With The Preliminary National Coverage Determination, This Has The Potential To Democratize Next-generation Sequencing, Lowering The Barriers For Patients Treated In The Community To Access These Biomarker-driven Treatments.
“comprehensive Genomic Profiling Is The Gateway To Precision Medicine. This Decision From The Fda And Cms, Which May Lead To Coverage For Medicare Patients, Represents An Important Step Forward In Improving Patient And Clinician Access To Precision Medicine – Both In Setting A New Quality Standard For This Type Of Testing And Offering Potentially Improved Healthcare Coverage,” Said Diver Cabana, Do, Medical Director Of Precision Medicine, Cancer Treatment Centers Of America. “access To Important Genomic Information Is A Critical Step In Being Able To Offer Innovative And Targeted Treatment Options.”
Foundationone Cdx Results Are Delivered In An Integrated Report That Identifies Alterations Matched To Fda Approved Therapies, Identifies Additional Alterations In Genes Known To Drive Cancer Growth, Furnishes Information About Genomic Biomarkers, Including Msi And Tmb, Provides Relevant Clinical Trial Information, And Includes Interpretive Content Developed In Accordance With Professional Guidelines In Oncology For Patients With Any Solid Tumor.
“today’s Historic Parallel Review Decision From The Fda And Cms Represents A Major Advancement In Personalized Cancer Care,” Said Troy Cox, Chief Executive Officer At Foundation Medicine. “physicians Will Have An Fda-approved Test For All Solid Tumors In Their Toolkit That Can Inform Targeted And Immunotherapy Selection, As Well As Identify Patient Opportunities For Clinical Trial Participation. Beyond Its Implications For Patient Care, We Expect That Foundationone Cdx Will Provide Biopharma Companies With An Fda-approved Platform That Can Help Accelerate Drug Development And Enable Personalized Oncology Care. On Behalf Of The Foundation Medicine Team, I’d Like To Thank Fda And Cms For Their Leadership And Collaboration As We Continue To Work Through The Parallel Review Process With A Shared Mission Of Transforming Cancer Care.”
Foundationone Cdx Is The First Solid Tumor Comprehensive Genomic Profiling Test Reviewed By The Fda And Cms In Their Parallel Review Program. Fda Approval Was Based On Analytic Validation And Concordance Studies With FDA-approved Assays. Foundationone Cdx Is Expected To Be Commercially Available Following Finalization Of The Ncd From CMS.
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. The Test Is Intended As A Companion Diagnostic To Identify Patients Who May Benefit From Treatment With The Targeted Therapies Listed Below In Accordance With The 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. The Foundationone Cdx Assay Is A Single-site Assay Performed At Foundation Medicine, Inc.
Cambridge, Mass.--(business Wire)--foundation Medicine, Inc. ('NASDAQ FMI') Today Announced That The U.s. Food And Drug Administration ('FDA') Approved Foundationone Cdx, The Company’s Comprehensive Companion Diagnostic Test For Solid Tumors. Foundationone Cdx Is Intended For Use By Health Care Professionals To Help Inform Cancer Treatment Management In Accordance With Professional Guidelines For Patients With Solid Tumors. The First And Only Fda-approved Test Of Its Kind For All Solid Tumors, Foundationone Cdx Is A Diagnostic Test That Acts As:
Access To Important Genomic Information Is A Critical Step In Being Able To Offer Innovative And Targeted Treatment Options.
Tweet This
A Comprehensive Companion Diagnostic To Identify Patients Who May Benefit From Treatment With Specific Fda-approved Targeted Therapies;
A Comprehensive Genomic Profiling ('CGP') Test That Includes Genomic Biomarkers To Help Inform The Use Of Other Targeted Oncology Therapies, Including Immunotherapies;
A Tool For Physicians That Identifies Patient Opportunities For Clinical Trial Participation; And,
An Fda-approved Platform For Companion Diagnostic Development For Biopharma Companies Developing Precision Therapeutics.
Foundationone Cdx Assesses All Classes Of Genomic Alterations In 331 Genes Known To Drive Cancer Growth, Providing Potentially Actionable Information To Help Guide Treatment Decisions. It Is Also Indicated As A Companion Diagnostic For Patients With Certain Types Of Non-Small Cell Lung Cancer ('NSCLC'), Melanoma, Colorectal Cancer, Ovarian Cancer Or Breast Cancer To Identify Those Patients Who May Benefit From Treatment With One Of 09 On-label Targeted Therapies, Including 11 Therapies Currently Approved As First-line Therapy For Their Respective Indications. Foundationone Cdx Also Reports Genomic Biomarkers, Such As Microsatellite Instability ('MSI') And Tumor Mutational Burden ('TMB'), That Can Help Inform The Use Of Immunotherapies; Genomic Alterations In Other Genes Relevant To Patient Management; And, Relevant Clinical Trial Information.
Based On Previous Cgp Testing Conducted By Foundation Medicine, It Is Estimated That Approximately 1 In 3 Patients Across Five Common Advanced Cancers Are Expected To Match With An Fda Approved Therapy.1 The Number Of Matched On-label Therapies Indicated On Foundationone Cdx Is Expected To Increase Over Time As Foundation Medicine And Its Biopharma Partners Pursue Fda Approval For Additional Companion Diagnostics On The Platform. Today, Approximately 43% Of New Cancer Drugs In Development Are Projected To Have A Companion Biomarker.2
Concurrent With Fda Approval, The Centers For Medicare And Medicaid Services ('CMS') Issued A Preliminary National Coverage Determination ('NCD') For Foundationone Cdx. 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 2018 Following Public Comment Of The Preliminary Ncd And An Administrative Period.
Today We Know That Many People With Cancer Do Not Receive Biomarker Testing, Let Alone The Comprehensive Genomic Testing They Need To Be Efficiently Matched To The Best Therapeutic Option,” Said Andrea Ferris, President And Ceo Of Lungevity Foundation. “this Fda Approval Means That, In One Test, Patients Can Access Therapies Where Companion Diagnostics Have Been Established For Their Cancer While Getting A Broad Tumor Profile That Can Identify The Therapies And Clinical Trials They Could Most Benefit From. Along With The Preliminary National Coverage Determination, This Has The Potential To Democratize Next-generation Sequencing, Lowering The Barriers For Patients Treated In The Community To Access These Biomarker-driven Treatments.
“comprehensive Genomic Profiling Is The Gateway To Precision Medicine. This Decision From The Fda And Cms, Which May Lead To Coverage For Medicare Patients, Represents An Important Step Forward In Improving Patient And Clinician Access To Precision Medicine – Both In Setting A New Quality Standard For This Type Of Testing And Offering Potentially Improved Healthcare Coverage,” Said Diver Cabana, Do, Medical Director Of Precision Medicine, Cancer Treatment Centers Of America. “access To Important Genomic Information Is A Critical Step In Being Able To Offer Innovative And Targeted Treatment Options.”
Foundationone Cdx Results Are Delivered In An Integrated Report That Identifies Alterations Matched To Fda Approved Therapies, Identifies Additional Alterations In Genes Known To Drive Cancer Growth, Furnishes Information About Genomic Biomarkers, Including Msi And Tmb, Provides Relevant Clinical Trial Information, And Includes Interpretive Content Developed In Accordance With Professional Guidelines In Oncology For Patients With Any Solid Tumor.
“today’s Historic Parallel Review Decision From The Fda And Cms Represents A Major Advancement In Personalized Cancer Care,” Said Troy Cox, Chief Executive Officer At Foundation Medicine. “physicians Will Have An Fda-approved Test For All Solid Tumors In Their Toolkit That Can Inform Targeted And Immunotherapy Selection, As Well As Identify Patient Opportunities For Clinical Trial Participation. Beyond Its Implications For Patient Care, We Expect That Foundationone Cdx Will Provide Biopharma Companies With An Fda-approved Platform That Can Help Accelerate Drug Development And Enable Personalized Oncology Care. On Behalf Of The Foundation Medicine Team, I’d Like To Thank Fda And Cms For Their Leadership And Collaboration As We Continue To Work Through The Parallel Review Process With A Shared Mission Of Transforming Cancer Care.”
Foundationone Cdx Is The First Solid Tumor Comprehensive Genomic Profiling Test Reviewed By The Fda And Cms In Their Parallel Review Program. Fda Approval Was Based On Analytic Validation And Concordance Studies With FDA-approved Assays. Foundationone Cdx Is Expected To Be Commercially Available Following Finalization Of The Ncd From CMS.
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. The Test Is Intended As A Companion Diagnostic To Identify Patients Who May Benefit From Treatment With The Targeted Therapies Listed Below In Accordance With The 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. The Foundationone Cdx Assay Is A Single-site Assay Performed At Foundation Medicine, Inc.
How A New Genomic Test Could Change Cancer Care
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