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Illumina, Adaptive Biotechnologies Partner on IVD Test Kits for Immune Sequencing

This story has been updated to include additional information from documents filed with the US Securities and Exchange Commission.

NEW YORK – Adaptive Biotechnologies today announced a non-exclusive partnership with Illumina to develop distributable in vitro diagnostic test kits for Adaptive's ClonoSeq and ImmunoSeq Dx assays.

Under the terms of the five-year agreement, Adaptive will develop the next-generation sequencing-based IVD assays to run on Illumina's NextSeq 550Dx system. Adaptive will be responsible for obtaining the necessary regulatory approvals for each kit and for commercializing them.

Illumina will develop custom software to support the use of the kits on NextSeq instruments and will provide regulatory and related support related to Illumina components and the custom software. It will exclusively license the software to Adaptive.

Adaptive will pay Illumina two technology access milestone payments related to the custom software development as well as tiered revenue share payments on net sales of the kits, ranging from a low to mid-single digit percentage of future net sales. Adaptive will also purchase instruments and consumables from Illumina to support pre-commercial development.

The planned test kits would make it possible for clinical laboratories to run Adaptive's assays on their own. Currently, Adaptive performs them as a service at its Seattle lab.

"We are proud to partner with Illumina to deliver on our promise to develop distributable kits for our novel immunodiagnostics to reach more patients," Adaptive CEO and Cofounder Chad Robins said in a statement. "These IVD test kits will further validate Adaptive as a valued partner for standardized minimal residual disease monitoring and immune profiling solutions from research to the clinic."

The partnership comes as San Diego-based Illumina is expanding the clinical applications of its NGS platform. Last year, Illumina CEO Francis deSouza said he expects clinical sequencing to soon account for more of the firm's business than the research market. And in 2018, the company signed deals to develop companion diagnostics to run on its NextSeq 550Dx with Bristol-Myers Squibb and Loxo Oncology.

The move also fits with recent comments from Adaptive officials. In August, Adaptive announced it would be launching a research-use-only ImmunoSeq kit by the end of 2019 and that it is in the process of developing a clinical version, the ImmunoSeq Dx. The firm is also pursuing an expanded label for ClonoSeq and to get the assay approved for use with blood samples, in addition to bone marrow samples.