ArcherDX and Illumina Partner for Future to Co-Market Portfolio of Planned In-Vitro Diagnostic Tests
January 10, 2020 at 01:00 pm
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ArcherDX, Inc. announced a non-exclusive, multi-year partnership with Illumina, Inc. intended to broaden access of next generation sequencing (NGS)-based oncology testing, including companion diagnostics for therapeutic selection, personalized monitoring, and recurrence surveillance IVD tests, upon FDA approval, enabling more patient access to world-class care in their own community, delivered by local clinicians. This partnership expands and builds upon existing agreements with Illumina including developing ArcherDX IVD tests to run on Illumina's NextSeq 550Dx and MiSeq Dx Systems as well as a prior agreement to co-market and co-promote the Archer FusionPlex line of research products in markets outside of the United States. The multi-year agreement covers co-marketing of future ArcherDX IVD tests used with the Illumina NextSeq 550Dx and MiSeq Dx Systems. Upon approval, these tests will generate the genomic information needed to guide optimal cancer treatment and deliver information to clinicians and patients for cancer monitoring and recurrence surveillance. Upon FDA approval, ArcherDX anticipates the first IVD to be marketed under the partnership will be the ArcherDX STRATAFIDE companion diagnostic (CDx). Upon FDA approval, STRATAFIDE would be the first pan-solid tumor IVD capable of identifying actionable genomic alterations in tissue or blood samples, including alterations targeted by emerging therapies undergoing clinical trials, therapies already recommended in clinical guidelines such as NCCN, and therapies approved by the FDA. These breakthrough capabilities would enable STRATAFIDE to be the first pan-solid tumor IVD NGS testing technology to accept both tissue and blood that can be used in any local hospital or regional reference lab with an Illumina sequencer. STRATAFIDE was granted FDA Breakthrough Device Designation in early 2019. Following FDA approval of STRATAFIDE, ArcherDX also plans to seek regulatory approval and launch its Personalized Cancer Monitoring (PCM) product. The ArcherDX PCM platform would enable local labs to assess therapy success and identify disease recurrence much earlier than current standard of care such as imaging or antigen test modalities, making successful treatment more likely.
Illumina, Inc. specializes in the development, manufacturing and marketing of integrated systems for the analysis of genetic variation and biological function. The group's products are for genomic research centers, pharmaceutical companies, university institutions, clinical research organizations, and biotechnology companies. Net sales break down by source of income as follows:
- product sales (84.1%): tools and instruments for sequencing, genotyping, genetic expression, etc.;
- sales of services (15.9%).
Net sales are distributed geographically as follows: the United States (52.4%), Americas (3.6%), Europe (25.3%), Asia/Pacific/Middle East/Africa (10.2%) and China/Taiwan/Hong Kong (8.5%).