August 24, 2017 3:54 AM ET

Biotechnology

Company Overview of Invivoscribe Technologies, Inc.

Company Overview

Invivoscribe Technologies, Inc., together with its subsidiaries, provides PCR-based gene rearrangement, chromosome translocation, and gene mutation research use only testing reagents, assays, and controls. It offers master mixes, DNA and RNA controls, analyte specific reagents, and CE marked assays. The company also offers in vitro diagnostic products to identify, classify, and monitor leukemia, lymphomas, and other lymphoproliferative diseases; and provides services focused on personalized molecular medicine, personalized molecular diagnostics, and biomarker testing. In addition, it offers LabFlow Software, an ERP software package, which helps in managing and coordinating GMP manufacturing ...

6330 Nancy Ridge Drive

Suite 106

San Diego, CA 92121-3230

United States

Founded in 1995

Phone:

858-224-6600

Fax:

858-224-6601

Key Executives for Invivoscribe Technologies, Inc.

Founder, Chief Executive Officer, Chief Scientific Officer, and Chairman
Chief Financial Officer
Chief Operating Officer
Age: 55
Compensation as of Fiscal Year 2017.

Invivoscribe Technologies, Inc. Key Developments

Invivoscribe(R) Releases LeukoStrat(R) CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit

Invivoscribe(R) Technologies Inc. announced the release of the CE-marked IVD version of its LeukoStrat(R) CDx FLT3 Mutation Assay which earlier this year was approved by the FDA1. The assay identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, missed using many current NGS-based assays. The kit includes CE-marked software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to midostaurin. Invivoscribe will also seek FDA approval of the LeukoStrat(R) CDx FLT3 Mutation Assay to allow the sale of kits to laboratories in the United States. The Invivoscribe LeukoStrat(R) CDx FLT3 Mutation Assay is the first companion diagnostic for AML, and the only commercially available signal ratio assay validated in international clinical trials so the results generated are harmonized for healthcare providers worldwide. It is currently being utilized for enrollment in multiple international clinical trials. Mutations in FLT3 are among the most common driver mutations, with the strongest effects on the overall survival in acute myeloid leukemia2 (AML), the most deadly form of leukemia, which is diagnosed in about 20,000 new patients each year in the U.S. and has only a 26.9% five-year survival rate3.

Invivoscribe Technologies Inc. Receives FDA Approval for the LeukoStrat(R) CDx FLT3 Mutation Assay

Invivoscribe Technologies Inc. announced the premarket approval of LeukoStrat(R) CDx FLT3 Mutation Assay. Due to current labeling for the FDA approved test, FLT3 mutation testing with LeukoStrat(R) CDx FLT3 Mutation Assay is exclusively performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for the Novartis drug Rydapt(R) in newly diagnosed FLT3+ AML. Under terms of a previously announced agreement with Thermo Fisher, Invivoscribe will also seek FDA approval of the LeukoStrat(R) CDx FLT3 Mutation Assay that will allow the sale of kits to other laboratories. The Invivoscribe LeukoStrat(R) CDx FLT3 Mutation Assay is a signal ratio assay that identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, which are missed using many current NGS-based assays. FLT3 somatic variants are among the most common driver mutations with the strongest effects on the overall survival in acute myeloid leukemia (AML), the most deadly form of leukemia, which is diagnosed in about 20,000 new patients each year in the U.S. and has only a 26.6% five-year survival rate2. Invivoscribe, working under a companion diagnostic agreement with Novartis, developed this companion diagnostic for FLT3 successfully achieving FDA regulatory approval. The Invivoscribe LeukoStrat(R) CDx FLT3 Mutation Assay is the first companion diagnostic for AML.

Invivoscribe Technologies Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits

Invivoscribe Technologies Inc. announced the expansion of its long-term collaboration agreement with Thermo Fisher Scientific to include development and commercialization of in vitro diagnostic (IVD) assays for the Applied Biosystems® 3500 Dx Series Genetic Analyzers. The company's previously announced agreement focuses on the development of IVD oncology tests for the Ion PGM™ Dx System. Under terms of the expanded agreement, Invivoscribe will seek FDA approval of a FLT3 Mutation Assay, as well as clearance of a number of B- and T-cell clonality and immuno-oncology assay kits that will run on the 3500 Dx capillary electrophoresis platform. The Invivoscribe FLT3 mutation assay is a signal ratio assay that identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, which are missed using many current NGS-based assays. FLT3 is the single most important biomarker for the stratification and prognosis of acute myeloid leukemia (AML), the most deadly form of leukemia, which is diagnosed in about 20,000 new patients each year in the U.S. and has only a 25%-40% five-year survival rate. Invivoscribe, working under a companion diagnostic agreement with Novartis, has developed a companion diagnostic for FLT3 that is currently under FDA review for use with PKC412 (midostaurin) an investigational drug in development for adults with newly-diagnosed AML who are FLT3 mutation-positive. This investigational compound was granted a Breakthrough Therapy designation by the US FDA in early 2016. The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay would be the first molecular companion diagnostic in AML.

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