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ArcherDx, Illumina Agree to Comarket Future IVDs

NEW YORK – ArcherDx said on Friday that it has signed a non-exclusive, multiyear partnership with Illumina intended to broaden access to next-generation sequencing oncology testing, including — upon regulatory approval — companion diagnostics for therapeutic selection, personalized monitoring, and new recurrence surveillance in vitro diagnostics.

The company said the agreement expands and builds upon other existing collaborations with Illumina, including partnerships to develop ArcherDx IVD tests to run on Illumina's NextSeq 550Dx and MiSeq Dx systems and an agreement to comarket and copromote the Archer FusionPlex line of research products in markets outside the United States.

Under the new agreement the companies will also co-market future ArcherDx IVDs alongside the NextSeq 550Dx and MiSeq Dx instruments. According to ArcherDx, the first of these new clinical assays is likely to be the ArcherDx Stratafide companion diagnostic.

Stratafide is a pan-solid tumor test designed to identify actionable genomic alterations in tissue or blood samples, including targets of both approved drugs and emerging therapies undergoing clinical trials. It was granted US Food and Drug Administration breakthrough device designation in early 2019.

Following FDA approval of Stratafide, ArcherDx said it also plans to seek regulatory approval for its Personalized Cancer Monitoring (PCM) product, designed to assess therapy success and identify early signs of disease recurrence.

The goal in linking its tests to the increasingly omnipresent Illumina installed base, ArcherDx said, is to help more patients access precision medicine by increasing local, decentralized options across community practices.

"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," ArcherDx CEO Jason Myers said in a statement.

"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," added Illumina CMO Phil Febbo.