February 2020—ArcherDX announced a nonexclusive, multiyear partnership with Illumina intended to broaden access of next-generation-sequencing–based oncology testing, including companion diagnostics for therapeutic selection, personalized monitoring, and recurrence surveillance IVD tests, upon FDA approval.
The multiyear agreement covers comarketing of future ArcherDX IVD tests used with the Illumina NextSeq 550Dx and MiSeq Dx systems. Upon approval, these tests will generate genomic information to help guide cancer treatment and deliver information to clinicians and patients for cancer monitoring and recurrence surveillance. ArcherDX anticipates that its Stratafide companion diagnostic will be the first IVD to be marketed under the partnership, upon FDA approval.
Stratafide is a 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. The test was granted FDA breakthrough device designation in early 2019.