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via CRUK

Diagnostic test specialists Invivoscribe have announced a new partnership with sequencing giant Illumina, to develop and commercialise in vitro diagnostic (IVD) assays for Illumina’s FDA approved next generation sequencing platform MiSeqDx.

Through the agreement, Invivoscribe will bring IVD assays for biomarker and immuno-oncology through the FDA for sale and distribution in the US. The company has already developed and commercialised a number of IVD assays for the Illumina 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.

“This 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,” said Dr. Jeffrey Miller, Founder, CSO & CEO of Invivoscribe.

“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. 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.”

Invivoscribe have already cemented a long-term collaboration with Thermo Fisher Scientific to develop NGS-based IVDs for cancer using Thermo’s Ion Torrent system.