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Invivoscribe, Illumina Partner to Develop, Market NGS-Based IVD Assays

NEW YORK (GenomeWeb) – Invivoscribe said today that it has inked a long-term collaboration with Illumina to develop and commercialize in vitro diagnostic assays for Illumina's MiSeqDx next-generation sequencing platform.

The agreement allows Invivoscribe to bring IVD assays and associated bioinformatics software through the US Food and Drug Administration for sale and distribution in the US, Invivoscribe said. Specifically, the companies will work together to seek FDA clearance or approval for a number of biomarker and immuno-oncology assay kits for use on the MiSeqDx.

Invivoscribe said it has already developed and commercialized several research-use-only and CE-marked IVD assays on Illumina's platform, including a FLT3 mutation assay; a series of B- and T-cell clonality assays used to detect IGH, IGK, and TRG rearrangements; and an IGHV somatic hypermutation assay. Invivoscribe added that it will release a TRB assay later this year.

The new agreement "allows us to move forward with the opportunity to offer more than just RUO assays here in the US; it allows us to provide laboratories with internationally standardized, FDA-approved and -cleared kits that will be of huge benefit to patients and to the field of personalized molecular diagnostics and precision medicine," Jeffrey Miller, founder, CSO, and CEO of Invivoscribe, said in a statement.

"A number of these assays and associated bioinformatics software have already been validated for use at LabPMM, our CLIA/CAP, ISO 15189-accredited, New York State-licensed laboratory in San Diego," Miller added. "They are currently being used by leading cancer treatment centers to optimize treatment for their patients, and by pharmaceutical partners to stratify, select, and track residual disease in subjects in international phase II and phase III clinical studies. We want to make these powerful tools accessible to all of our partners and customers."

The company currently has companion diagnostics development partnerships with Novartis and Astellas Pharma, and expects to announce additional collaborations in 2017.

Invivoscribe already has a long-term collaboration in place with Thermo Fisher Scientific to develop NGS-based IVDs for cancer on Thermo's Ion PGM Dx system. Last month, the companies expanded that relationship to develop and commercialize IVD assays for the Applied Biosystems 3500Dx genetic analyzer.