Premarket Approval Sought for CDx Test to Benefit Lung Cancer Patients
By LabMedica International staff writers Posted on 25 Jan 2015 |
Image: Positive case of lung tissue stained for ALK with VENTANA ALK (D5F3) CDx Assay, a companion diagnostic immunohistochemical test in the final stages of the FDA premarket approval process (Photo courtesy of Ventana Medical Systems and PRNewsFoto).
Ventana Medical Systems, Inc. (Tucson, AZ, USA) has announced its US Food & Drug Administration (FDA) final stage submission for premarket approval (PMA) of its companion diagnostic (CDx) immunohistochemistry (IHC) test designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene.
The submission is for the VENTANA ALK (D5F3) CDx Assay, and is the fourth and final module and application required by the PMA process.
"Premarket approval of the VENTANA ALK (D5F3) CDx Assay will enable more lung cancer patients to access ALK gene testing and obtain faster test results over current FISH or molecular testing methods. We are very pleased about the potential impact of this important diagnostic," said Doug Ward, Lifecycle Leader, Companion Diagnostics, Ventana Medical Systems.
"We're extremely pleased to have finalized the submission of the VENTANA ALK (D5F3) CDx Assay. PMA is the most stringent type of device marketing application required by the FDA. Our 4-step modular submission process for premarket approval is a major progression as it has enabled the FDA to review each module after submission and provide us with timely feedback. This helps mitigate potential delays early in the review process and ensures a more efficient and effective approval process," said Troy Quander, vice president, Regulatory Affairs, Ventana Medical Systems.
Non-small-cell lung cancer (NSCLC) is the most common subtype of lung cancer. About 5% of NSCLC patients have a rearrangement in the gene ALK (anaplastic lymphoma receptor tyrosine kinase). This mutation is most often seen in nonsmokers (or light smokers) who have the adenocarcinoma subtype of NSCLC. The rearrangement produces an abnormal ALK protein that causes the cells to grow and spread. The new VENTANA ALK (D5F3) CDx Assay provides patients and their physicians with a highly efficient, standardized, and cost effective method for assessing ALK protein expression and eligibility for available targeted therapy. IHC testing is widely accessible on VENTANA BenchMark XT instruments.
A drug development program with a CDx strategy may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients. Ventana has worked with over 45 biopharmaceutical partners and is currently engaged in over 180 collaborative projects to develop and commercialize CDx globally.
Related Links:
Ventana Medical Systems
The submission is for the VENTANA ALK (D5F3) CDx Assay, and is the fourth and final module and application required by the PMA process.
"Premarket approval of the VENTANA ALK (D5F3) CDx Assay will enable more lung cancer patients to access ALK gene testing and obtain faster test results over current FISH or molecular testing methods. We are very pleased about the potential impact of this important diagnostic," said Doug Ward, Lifecycle Leader, Companion Diagnostics, Ventana Medical Systems.
"We're extremely pleased to have finalized the submission of the VENTANA ALK (D5F3) CDx Assay. PMA is the most stringent type of device marketing application required by the FDA. Our 4-step modular submission process for premarket approval is a major progression as it has enabled the FDA to review each module after submission and provide us with timely feedback. This helps mitigate potential delays early in the review process and ensures a more efficient and effective approval process," said Troy Quander, vice president, Regulatory Affairs, Ventana Medical Systems.
Non-small-cell lung cancer (NSCLC) is the most common subtype of lung cancer. About 5% of NSCLC patients have a rearrangement in the gene ALK (anaplastic lymphoma receptor tyrosine kinase). This mutation is most often seen in nonsmokers (or light smokers) who have the adenocarcinoma subtype of NSCLC. The rearrangement produces an abnormal ALK protein that causes the cells to grow and spread. The new VENTANA ALK (D5F3) CDx Assay provides patients and their physicians with a highly efficient, standardized, and cost effective method for assessing ALK protein expression and eligibility for available targeted therapy. IHC testing is widely accessible on VENTANA BenchMark XT instruments.
A drug development program with a CDx strategy may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients. Ventana has worked with over 45 biopharmaceutical partners and is currently engaged in over 180 collaborative projects to develop and commercialize CDx globally.
Related Links:
Ventana Medical Systems
Latest Industry News
- Beckman Coulter Partners with BioPorto for Global Distribution of Acute Kidney Injury NGAL Tests
- CACLP 2025 New Date and Venue Announced
- Roche to Develop New Diagnostic Technologies for Traumatic Brain Injuries
- LGC Clinical Diagnostics and AccuGenomics Collaborate on Enhancing Cancer Testing Accuracy
- Beckman Coulter and SphingoTec Partner to Improve Kidney Health Assessment in Critical Care
- Seegene and Werfen Finalize Partnership Agreement on Technology-Sharing Initiative
- Cepheid Partners with Fleming Initiative to Fight Antimicrobial Resistance
- MEDICA LABMED FORUM 2024: International Experts Meet to Discuss Trending Topics in Laboratory Medicine
- Nova Biomedical and Terumo BCT Collaborate on Automated Cell Culture Sensing
- Beckman Coulter and Scopio Labs Add World's First Digital Bone Marrow Imaging and Analysis to Long-Term Partnership
- Roche Expands Digital Pathology Open Environment with Integration of Advanced AI Algorithms from New Collaborators
- Qiagen and Eli Lilly to Develop First QIAstat-Dx IVD Panel for Neurodegenerative Applications
- QIAGEN and AstraZeneca Expand Collaboration into New Disease Areas
- MEDICA 2024 + COMPAMED 2024: Adapted Hall Layout for Better Integration
- Global Coagulation Testing Driven by Increasing Blood Disorders and Surgical Interventions
- Sysmex and QIAGEN Expand Collaboration in Genetic Testing