The partnership between Qiagen and NeoGenomics, a provider of cancer-focused genetic testing services, will ensure Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.
Building on the US Food and Drug Administration's modernized regulatory approach to advanced diagnostics, especially next-generation sequencing tests, the collaboration with NeoGenomics will allow Qiagen and pharmaceutical partners to streamline the development and launch of targeted drugs and companion diagnostics to guide treatment decisions.
The partnership offers flexible pathways leading to introduction of FDA-approved companion diagnostics simultaneously with launch of new therapies.
Qiagen and NeoGenomics will discuss their efforts to expedite access for precision medicine solutions at the American Society of Hematology 2018 annual meeting and Exposition from December 1-4, 2018, in San Diego.
NeoGenomics has a national footprint and broad customer reach in cancer-related genetic testing services and one of the most comprehensive oncology-focused test menus.
The master service agreement provides a flexible framework with multiple options for co-development, verification, setup, and launch of new companion diagnostics, including next-generation sequencing tests, for biomarker profiling paired with new targeted drugs.
As Qiagen collaborates with pharma and biotech partners, co-development progresses from drug discovery and creation of a biomarker test, to clinical development evaluating the proposed drug and test, to validation for clinical use and then commercialization of the new drug and companion diagnostic.
Commercial alignment and launch readiness for companion diagnostics at the time of drug approval have become increasingly important for Qiagen's´s pharmaceutical partners.
Qiagen, a Netherlands-based holding company, is a provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life.
Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis.
Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows.
NeoGenomics specialises in cancer genetics testing and information services.
Headquartered in Fort Myers, Florida, NeoGenomics operates CLIA-certified laboratories in Aliso Viejo and Fresno, California; Tampa and Fort Myers, Florida; Houston, Texas; Nashville, Tennessee, and Rolle, Switzerland.
Innovent treats first cancer patient in Phase I clinical trial of Anti-OX40 Antibody
Mayne Pharma unveils Lexette (halobetasol propionate) foam 0.05% in the US plaque psoriasis market
US FDA posts warning letters to companies illegally selling more than 58 products
Parexel Appoints Former FDA Senior Executives to Global Regulatory Consulting Services
US Patent Issued for AXA Candidate AXA1125
Omeros Names Bumol to Board of Directors
Calliditas Therapeutics announces grant of ODD by US FDA for primary biliary cholangitis
Harmony Biosciences submits Pitolisant NDA with US FDA under priority review
Calliditas Therapeutics wins US FDA orphan drug designation for primary biliary cholangitis