Invivoscribe will develop the biomarker tests, along with the test controls and related bioinformatics software, for screening of research specimens, along with surveillance, monitoring, and detection of measurable residual disease (MRD)
Invivoscribe has teamed up with Complete Genomics to develop and commercialise biomarker tests on the latter’s NGS platforms to support oncology and cancer research.
Under the partnership, Invivoscribe will carry out the development of biomarker tests, including test controls and related bioinformatics software.
The CLIA/CAP-validated biomarker tests will be developed within Invivoscribe’s network of clinical LabPMM laboratories in the US, Europe, Japan, and China.
They will be used for screening research specimens, along with surveillance, monitoring, and detection of measurable residual disease (MRD) in a clinical research setting.
The biomarker tests will be initially released worldwide, as Research Use Only (RUO).
Invivoscribe CEO and CSO Jeffrey Miller said: “We are thrilled to be partnered with Complete Genomics worldwide, as they offer NGS platforms with excellent performance metrics, and lower cost systems and reagents vs. those provided by the other NGS providers.
“Our LeukoStrat CDx FLT3 Mutation Assay is an internationally standardized, FDA and IVDR-approved PCR-based capillary test that has proven invaluable as a companion diagnostic for three approved FLT3 targeted therapies.
“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 biomarker tests will be developed for the Complete Genomics DNBSEQ-G99 platform.
They will include both screening and highly sensitive MRD monitoring research for the full range of hematologic malignancies, including acute myeloid leukaemia (AML).
AML is a blood cancer that affects the blood and bone marrow, characterised by the rapid growth of abnormal white blood cells.
Furthermore, the partnership plans to expand its relationship into global clinical studies and regulatory submissions to support the in vitro diagnostic (IVD) testing products.
Complete Genomics CEO Yongwei Zhang said: “We are thrilled to be partnering with Invivoscribe, a proven developer of high-quality tests to deliver a complete workflow solution.”