Invivoscribe, Complete Genomics to develop biomarker tests for oncology research

Invivoscribe and Complete Genomics have announced a partnership aimed at developing and commercializing biomarker tests on the latter’s next-generation sequencing (NGS) platforms.

The collaboration, covering worldwide territories, focuses on oncology and cancer research.

Based in California, Invivoscribe is specialized in precision diagnostics and reagents for hematologic malignancies and molecular diagnostics.

Also based in California, Complete Genomics specializes in genomic sequencing and analysis. It offers innovative solutions for whole-genome sequencing (WGS) and related services.

Under the agreement, Invivoscribe will take the lead in developing biomarker tests, including test controls and associated bioinformatics software. These tests will serve various purposes, such as upfront screening of research specimens, as well as surveillance, monitoring, and detection of measurable residual disease (MRD) in clinical research settings.

Initially, the biomarker tests will be made available worldwide as Research Use Only (RUO) products.

In the future, Invivoscribe plans to develop CLIA/CAP-validated tests within its global network of clinical LabPMM laboratories located in the US, Europe, Japan, and China. Additionally, long-term plans involve expanding the partnership to encompass clinical studies and regulatory submissions worldwide, supporting the commercialization of in vitro diagnostic (IVD) testing products.

The biomarker tests being developed for Complete Genomics’ DNBSEQ-G99 platform will cover both screening and highly sensitive MRD monitoring research for a wide range of hematologic malignancies, including acute myeloid leukemia (AML).

One of the specific targets in the biomarker tests is the FLT3-ITD mutation, which is present in approximately 25% of AML patients. This mutation contributes to the growth and survival of cancer cells and is associated with a poor prognosis.

Jeffrey Miller — Invivoscribe CEO and CSO said: “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.”

The partnership between Invivoscribe and Complete Genomics represents a significant step forward in the field of oncology research. By leveraging the capabilities of Complete Genomics’ NGS platforms and Invivoscribe’s expertise in developing biomarker tests, the collaboration aims to improve screening and monitoring methods for hematologic malignancies like AML.

The development of CLIA/CAP-validated tests and future expansion into clinical studies and regulatory submissions hold the potential to facilitate the commercialization of advanced diagnostic products for improved patient outcomes in the future.

Yongwei Zhang — Complete Genomics CEO said: “We are thrilled to be partnering with Invivoscribe, a proven developer of high-quality tests to deliver a complete workflow solution.”