WE ARE THRILLED TO BE PARTNERED WITH COMPLETE GENOMICS WORLDWIDE , AS THEY OFFER NGS PLATFORMS WITH EXCELLENT PERFORMANCE METRICS .
INDUSTRY WATCH
WE ARE THRILLED TO BE PARTNERED WITH COMPLETE GENOMICS WORLDWIDE , AS THEY OFFER NGS PLATFORMS WITH EXCELLENT PERFORMANCE METRICS .
Invivoscribe and Complete Genomics have entered a partnership to develop and commercialize biomarker tests on Complete Genomics ’ NGS platforms .
The territory is worldwide and the field is oncology and cancer research .
Under the terms of the deal , Invivoscribe will be responsible for the development of biomarker tests , including test controls and associated bioinformatics software .
These biomarker tests can be used for upfront screening of research specimens , as well as for surveillance , monitoring and detection of measurable residual disease ( MRD ) in a clinical research setting .
The biomarker tests will initially be released worldwide as Research Use Only ( RUO ).
Additionally , development of CLIA / CAP-validated tests within Invivoscribe ’ s worldwide network of clinical LabPMM laboratories in the US , Europe , Japan and China is planned . Long-term plans include expansion of the relationship into clinical studies and regulatory submissions worldwide to support commercialization of in vitro diagnostic ( IVD ) testing products .
“ 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 versus those provided by the other NGS providers ,” said Jeffrey Miller , CEO and CSO , Invivoscribe .
“ 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 .
“ So , among the first tests we will develop and launch as RUO kits on the Complete Genomics DNBSEQ-G99 platform is our FLT3-ITD MRD test , which is currently being offered as a CLIA / CAP testing service in our LabPMM laboratories on another NGS platform and is being used by investigators to monitor and track residual disease in AML subjects in a clinical research setting .”
Yongwei Zhang , CEO , Complete Genomics , said : “ We are thrilled to be partnering with Invivoscribe , a proven developer of high-quality tests to deliver a complete workflow solution .
Tests being developed for the Complete Genomics DNBSEQ-G99 platform will include both screening and highly sensitive MRD monitoring research for the full range of hematologic malignancies , including acute myeloid leukemia ( AML ) a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells .
AML has the lowest 5-year survival rate ( 31.7 %) among those diagnosed with leukemia . About 25 % of AML patients have a FLT3-ITD mutation , which contributes to the growth and survival of cancer cells and is associated with a poor prognosis . p
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