May 29, 2016 5:47 PM 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.

Chairman, Chief Executive Officer, Chief Scientific Officer and Member of Scientific Advisory Board
Chief Financial Officer
Director of Operations
Director of Regulatory Affairs
Senior Legal Counsel of Special Projects and Director
Compensation as of Fiscal Year 2015.

Invivoscribe Technologies, Inc. Key Developments

German Supreme Court Upholds and Strengthens Invivoscribe Technologies Inc.'s FLT3 Patent Position

In a landmark patent decision that will accelerate approval of new drugs and improve treatment of patients with acute myeloid leukemia (AML), the highest court in Germany has upheld Invivoscribe Technologies Inc.'s FLT3 patent position. The decision of the German Federal Court of Justice (Bundesgerichtshof) rejected claims that the patent was invalid for lack of novelty and patentability of subject matter and leaves entirely intact 16 of the original 20 claims in the German version of the European FLT3 testing patent EP 959,132, which is licensed exclusively to Invivoscribe by Takara Bio Inc. of Kusatsu, Japan. The written grounds for the decision were served on March 18, 2016, following a January 19, 2016 court hearing that lasted more than four hours before a panel of five judges. Invivoscribe and Takara prevailed against an appeal by MLL Münchner Leukämielabor GmbH (MLL) of an earlier decision by the German Federal Patent Court and also prevailed on the critical issues in a cross-appeal against MLL. Critically, the high court upheld the key testing method claim that resulted in a ruling by the Munich District Court that MLL infringed Invivoscribe's FLT3 testing patent rights. The high court also reinstated a number of original patent claims. The Munich District Court will now determine the damages owed by MLL for its patent infringement. Invivoscribe believes that this decision will help stimulate and accelerate additional therapeutic drug approvals, all of which should increase the current 25% five year survival rate for AML patients. Recently it was announced that the first targeted therapy for AML demonstrated a 23% increase in the overall survival of FLT3-positive AML patients treated with the new Novartis drug, midostaurin. On February 19, 2016 the FDA designated midostaurin as a Breakthrough Therapy for newly diagnosed FLT3 mutated AML. Invivoscribe's internationally harmonized FLT3 signal ratio assay and associated software are being submitted to regulatory authorities as the companion diagnostic for this new drug, which represents the first targeted therapy for AML and the first new drug likely to be approved for treating AML in the past 25 years.

Invivoscribe Technologies, Inc. Announces Long-Term Collaboration to Develop Immuno-Oncology Tests with Thermo Fisher Scientific

Invivoscribe Technologies, Inc. announced that it has signed a long-term strategic collaboration agreement with Thermo Fisher Scientific to develop multiple next-generation sequencing (NGS)-based, in vitro diagnostic (IVD) oncology tests on the Ion PGM Dx System. Under terms of the agreement, Invivoscribe will leverage its more than two decades of development, validation and commercialization experience to manufacture and commercialize immuno-oncology molecular diagnostics and associated bioinformatics software for application in liquid biopsies. The assays may become powerful tools for diagnosis and minimal residual disease (MRD) monitoring of the full range of hematologic malignancies. The collaboration is consistent with Invivoscribe's ongoing global initiative to develop and provide internationally standardized, regulatory-compliant molecular diagnostic assays to support precision medicine in oncology. Invivoscribe's test menu is used by more than 600 institutional customers in 65 countries and the company currently sells a number of CE-marked IVD assays for NGS.

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