Invivoscribe will develop biomarker tests including test controls. Credit: CDC on Unsplash.

Invivoscribe has partnered with Complete Genomics to develop and commercialise biomarker tests for cancer and oncology research.

The partnership will use next-generation sequencing (NGS) platforms from Complete Genomics to develop new tests.

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As per the agreement, Invivoscribe will develop biomarker tests, including test controls and related bioinformatics software.

These biomarker tests will be utilised to screen research specimens upfront. Other applications include surveillance, monitoring and detection of measurable residual disease (MRD) in a clinical research environment.

The biomarker tests will initially be launched globally for research use only.

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Invivoscribe CEO and CSO Jeffrey Miller said: “Our LeukoStrat CDx FLT3 Mutation Assay is an internationally standardised, FDA and IVDR-approved PCR-based capillary test that has proven invaluable as a companion diagnostic for three approved FLT3 targeted therapies.

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“Though it is available worldwide both as a kit and as a testing service in our LabPMM laboratories, in order to study and monitor the level of AML disease following the identification of FLT3-positive AML subjects, we also need to provide a highly sensitive NGS-based FLT3 test.”

The partnership also plans to develop Clinical Laboratory Improvement Amendments-certified and College of American Pathologists-accredited tests within Invivoscribe’s worldwide network of clinical LabPMM laboratories in Japan, China, Europe and the US.

The companies also intend to explore the expansion of the partnership into clinical trials and regulatory submissions globally to help commercialise in vitro diagnostic testing solutions.

The upcoming tests for the Complete Genomics DNBSEQ-G99 platform will cover screening and MRD-monitoring research for various haematologic malignancies such as acute myeloid leukaemia (AML).