ArcherDx, Boulder, Colo, and Illumina, San Diego, have entered into a nonexclusive, multiyear partnership to broaden patient access to next-generation sequencing (NGS)-based oncology testing, including companion diagnostics for therapy selection, personalized monitoring, and recurrence surveillance.
“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, CEO 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.
Jason Myers, ArcherDx.
“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,” Myers adds. “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 between the companies, including a previous agreement to develop ArcherDx tests to run on Illumina’s NextSeq 550Dx and MiSeq Dx systems, as well as an 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 IVDs used with Illumina systems. With regulatory authorization, the 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.
ArcherDx anticipates the first IVD to be marketed under the partnership will be the company’s Stratafide companion diagnostic, which received an FDA breakthrough device designation in early 2019. Upon FDA approval, the Stratafide test is expected to be the first commercially available pan-solid tumor IVD capable of identifying actionable genomic alterations in tissue or blood samples, including alterations targeted by therapies already approved by FDA, by therapies recommended in clinical guidelines such as those of the National Comprehensive Cancer Network, and by emerging therapies now undergoing clinical trials. The test is expected to be approved for use in any local hospital or regional reference lab with an Illumina sequencer.
Following FDA approval of Stratafide, ArcherDx also plans to seek regulatory approval and launch its personalized cancer monitoring (PCM) product. The ArcherDx PCM platform is intended to enable local labs to assess therapy success and identify disease recurrence earlier than such standard-of-care modalities as imaging or antigen testing, 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.
