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SAN DIEGO and SAN JOSE, Calif., June 2, 2023 /PRNewswire/ — Invivoscribe and Complete Genomics announced today that they had 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 vs. those provided by the other NGS providers," said Jeffrey Miller, CEO and CSO at 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."
"We are thrilled to be partnering with Invivoscribe, a proven developer of high-quality tests to deliver a complete workflow solution," Yongwei Zhang, CEO of Complete Genomics.
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). AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 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.3
About Invivoscribe
Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, bioinformatics tools, and services to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies, providing expertise in diagnostic development and regulatory submission through commercialization of companion diagnostics. For additional information, please visit www.invivoscribe.com.
About Complete Genomics
Complete Genomics is a pioneering life sciences company that provides novel, end to end DNA sequencing solutions. It has been at the forefront of high throughput sequencing technology development since its inception in 2005. Our products have powered over 4,000 publications across a wide array of applications. To learn more, visit www.completegenomics.com.
1 https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/introduction
2 https://seer.cancer.gov/statfacts/html/amyl.html
3 Daver N et al. Leukemia (2019) 33:299–312.