Monday January 13, 2020 0 comments
BOULDER -- ArcherDX, Inc. announced a non-exclusive, multi-year partnership with San Diego-based Illumina, Inc. (NASDAQ: ILMN) that aims to broaden access of next generation sequencing (NGS)-based oncology testing.
That includes 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.
"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," said Jason Myers, ArcherDX CEO.
"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 decision making 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. It also allows hospitals and local labs to benefit as they can garner a growing share of the cancer diagnostics and monitoring market."
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 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.
ArcherDX said 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 said it 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," said Dr. Phil Febbo, Illumina chief medical officer.
"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."