ArcherDx, Boulder, Colo, and Illumina, San Diego, have formed a nonexclusive, multiyear partnership intended to broaden access to next-generation sequencing (NGS)-based oncology testing, including companion diagnostics for therapeutic selection, personalized monitoring, and recurrence surveillance. Upon FDA approval, the partnership’s in vitro diagnostics (IVDs) will support greater patient access to world-class care in their own community, delivered by local clinicians.
“Creating broad access to clinically relevant genomic information is core to our company’s mission, and we expect this commercial partnership with Illumina will accelerate that process,” says Jason Myers, chief executive officer of ArcherDx. “Illumina’s NGS instruments are ubiquitous in thousands of clinical and research settings due to their accuracy, speed, and user experience. That technology, together with our planned IVD test kits and companion software, will allow these platforms to guide clinical decisionmaking and targeted therapy.
“The resulting shift away from a handful of centralized sequencing labs to more decentralized testing benefits patients through faster results, more competitive pricing, and access to world-class cancer care delivered locally,” adds Myers. “It also allows hospitals and local labs to benefit, as they can garner a growing share of the cancer diagnostics and monitoring market.”
The partnership expands and builds upon existing agreements, including an agreement for the development of ArcherDx IVD tests to run on Illumina’s NextSeq 550Dx and MiSeq Dx systems, as well as a prior agreement to comarket and copromote the Archer FusionPlex line of research products in markets outside the United States.
The multiyear agreement covers comarketing of future ArcherDx IVD tests used with the Illumina NextSeq 550Dx and MiSeq Dx Systems. Upon approval, such 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.
Stratafide is expected to 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 those of the National Comprehensive Cancer Network, and therapies approved by FDA. Stratafide would be the first pan-solid tumor IVD NGS testing technology to accept both tissue and blood for use in any local hospital or regional reference lab with an Illumina sequencer.
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.
“Since our initial partnership in 2016, we have remained aligned with ArcherDx via our shared mission to bring actionable genomic insights closer to patients,” says Phil Febbo, MD, chief medical officer at Illumina. “We are pleased to take this next step in our commercial partnership to support expanding access to leading-edge genomic cancer management to more patients, in more communities, to improve patient outcomes.”
For more information, visit ArcherDx and Illumina.