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We are pleased to announce that Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI and the EMA as a Class C CDx assay, meeting the stringent new IVDR 2017/746) requirements.

Invivoscribe and Complete Genomics announced that they had entered a partnership to develop and commercialize biomarker tests on Complete Genomics’ NGS platforms.

Hitachi High-Tech Corporation (“Hitachi High-Tech”) has entered into a strategic partnership (the Partnership) with Invivoscribe, Inc. (“Invivoscribe”), a global provider of blood cancer testing kits and services, by undertaking a minority investment-based, third-party allotment of shares.

Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA®.

Invivoscribe is pleased to announce that their LeukoStrat CDx FLT3 Mutation Assay® has received updated reimbursement by Japan’s Ministry of Health, Labor and Welfare to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA®.

Kronos Bio, Inc., a company dedicated to transforming the lives of those affected by cancer, and Invivoscribe, a global provider of diagnostic kits and services for oncology, announced their agreement to develop a companion diagnostic for use with Kronos Bio’s investigational therapy, entospletinib.