Amgen and Illumina Collaborate on Oncology Companion Diagnostic Test
By LabMedica International staff writers Posted on 29 Jan 2014 |
Caption: Illumina\'s FDA-cleared MiSeqDx sequencing instrument (Image courtesy of Illumina).
Illumina (San Diego, CA, USA) will develop an in vitro diagnostic (IVD) kit on its FDA-cleared MiSeqDx sequencing instrument for Amgen’s (Thousand Oaks, CA, USA) colorectal cancer therapeutic Vectibix.
Illumina and Amgen have entered into an agreement for the development of a multigene, new generation sequencing (NGS)-based IVD test as a companion diagnostic for Vectibix (panitumumab), a human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the USA and the EU. Under the terms of the collaboration, premarket approval of the test by the US Food and Drug Administration (FDA) and other regulatory bodies will be sought. Illumina will develop the test for use with its MiSeqDx instrument, which received premarket clearance from the FDA on November 19, 2013 and was CE-marked for the European Union on July 16, 2013. The project will seek to validate a test platform that can identify RAS mutation status of patients who would be appropriate to receive Vectibix.
The collaboration reflects Illumina’s commitment to partnering with therapeutics companies. “This collaboration is consistent with our strategy to bring the power of NGS to clinical diagnostics,” said Nick Naclerio, senior vice president of Corporate and Venture Development and general manager of Illumina’s Enterprise Informatics business; “With three FDA-cleared NGS products in our portfolio, we intend to complement internal development programs by taking products developed with external partners through the FDA submission process. Amgen is a key partner given their leadership in therapeutic development and strong track record in commercializing novel products.”
Illumina is also bringing its NGS technologies into oncology care. Dr. Rick Klausner, Chief Medical Officer and acting General Manager of Illumina’s Oncology business, said, “NGS provides an advantage over traditional technologies that typically detect only one or a few variants. Multigene NGS panels provide a more complete genetic picture of each patient’s tumor, which can better inform critical treatment decisions. We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes."
Related Links:
Illumina
Amgen
Illumina and Amgen have entered into an agreement for the development of a multigene, new generation sequencing (NGS)-based IVD test as a companion diagnostic for Vectibix (panitumumab), a human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the USA and the EU. Under the terms of the collaboration, premarket approval of the test by the US Food and Drug Administration (FDA) and other regulatory bodies will be sought. Illumina will develop the test for use with its MiSeqDx instrument, which received premarket clearance from the FDA on November 19, 2013 and was CE-marked for the European Union on July 16, 2013. The project will seek to validate a test platform that can identify RAS mutation status of patients who would be appropriate to receive Vectibix.
The collaboration reflects Illumina’s commitment to partnering with therapeutics companies. “This collaboration is consistent with our strategy to bring the power of NGS to clinical diagnostics,” said Nick Naclerio, senior vice president of Corporate and Venture Development and general manager of Illumina’s Enterprise Informatics business; “With three FDA-cleared NGS products in our portfolio, we intend to complement internal development programs by taking products developed with external partners through the FDA submission process. Amgen is a key partner given their leadership in therapeutic development and strong track record in commercializing novel products.”
Illumina is also bringing its NGS technologies into oncology care. Dr. Rick Klausner, Chief Medical Officer and acting General Manager of Illumina’s Oncology business, said, “NGS provides an advantage over traditional technologies that typically detect only one or a few variants. Multigene NGS panels provide a more complete genetic picture of each patient’s tumor, which can better inform critical treatment decisions. We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes."
Related Links:
Illumina
Amgen
Latest Industry News
- Danaher and Johns Hopkins University Collaborate to Improve Neurological Diagnosis
- Beckman Coulter and MeMed Expand Host Immune Response Diagnostics Partnership
- Thermo Fisher and Bio-Techne Enter Into Strategic Distribution Agreement for Europe
- ECCMID Congress Name Changes to ESCMID Global
- Bosch and Randox Partner to Make Strategic Investment in Vivalytic Analysis Platform
- Siemens to Close Fast Track Diagnostics Business
- Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics
- Sysmex and Hitachi Collaborate on Development of New Genetic Testing Systems
- Sysmex and CellaVision Expand Collaboration to Advance Hematology Solutions
- BD and Techcyte Collaborate on AI-Based Digital Cervical Cytology System for Pap Testing
- Medlab Middle East 2024 to Address Transformative Potential of Artificial Intelligence
- Seegene and Microsoft Collaborate to Realize a World Free from All Diseases and Future Pandemics
- Medlab Middle East 2024 to Highlight Importance of Sustainability in Laboratories
- Fujirebio and Agappe Collaborate on CLIA-Based Immunoassay
- Medlab Middle East 2024 to Highlight Groundbreaking NextGen Medicine
- bioMérieux Acquires Software Company LUMED to Support Fight against Antimicrobial Resistance