ArcherDx and Illumina to Partner, Co-Market In Vitro Diagnostics

ArcherDx and Illumina to Partner, Co-Market In Vitro Diagnostics

ArcherDx said today it has signed a non-exclusive, multi-year commercial partnership agreement with Illumina through which the companies agreed to co-market future ArcherDX in vitro diagnostic (IVD) tests used with Illumina’s NextSeq 550Dx and MiSeq Dx sequencing systems.

The value of the agreement was not disclosed.

Archer said its future tests—which have yet to be approved by the FDA—will be designed to generate genomic information needed to guide optimal cancer treatment, as well as deliver information to clinicians and patients for cancer monitoring and recurrence surveillance.

Upon FDA approval, ArcherDX added, the first IVD to be marketed under the partnership will be the ArcherDX STRATAFIDE pan-solid tumor companion diagnostic (CDx). According to the company, STRATAFIDE would be the first multi-gene, pan-solid tumor companion diagnostic designed to accept both tissue and blood samples, and which can be used in any local hospital or regional reference lab with an Illumina sequencer.

“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,” ArcherDX CEO Jason Myers said in a statement. “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 partnership, Myers added, reflects the ongoing shift from centralized sequencing labs to more decentralized testing—a shift he said benefits patients through faster results, lower pricing, and greater access to world-class yet locally-delivered cancer care: “It also allows hospitals and local labs to benefit as they can garner a growing share of the cancer diagnostics and monitoring market.”

STRATAFIDE has been developed to identify actionable genomic alterations in tissue or blood, including alterations targeted by emerging therapies undergoing clinical trials, therapies already recommended in clinical guidelines such as those of the National Comprehensive Cancer Network (NCCN), and therapies approved by the FDA. STRATAFIDE received the FDA’s Breakthrough Device Designation in January 2019, and has been used by investigators in studies reported in more than 150 peer-reviewed publications.

Following FDA approval of STRATAFIDE, ArcherDX said it also plans to seek regulatory approval and launch its Personalized Cancer Monitoring (PCM) platform. PCM is designed to 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.

Furthering the development of STRATAFIDE and PCM were among uses identified for the proceeds of the $55 million in Series C financing completed in December 2019 by ArcherDx. The company has raised $150 million in total capital since it was founded in 2013.

The partnership builds upon a partnership agreement with Illumina signed in December 2019 to develop ArcherDX IVD tests that will be designed to run on Illumina’s NextSeq 550Dx and MiSeq Dx sequencing systems—as well as an agreement reached in June 2016 through which Illumina agreed to co-market and co-promote the Archer FusionPlex line of research products in markets outside of the U.S.

“Since our initial partnership in 2016, we have remained aligned with ArcherDX via our shared mission to bring actionable genomic insights closer to patients,” stated Phil Febbo, MD, Illumina’s 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.”