The benefits of standardizing molecular diagnostic tests cannot be overstated. In this exciting new age of molecular medicine and gene-targeted therapies, both academic experts and regulatory authorities clearly understand that tests need to be both consistent and accurate. "A bad test is as dangerous to a patient as a bad drug," as Dr. Richard Schilsky (President: American Society of Clinical Oncologists; University of Chicago) recently stated.
Looking forward, Invivoscribe is developing, refining, validating and preparing for regulatory approval a harmonized and consistent FLT3 mutation test that can be used worldwide to direct targeted drug treatments for AML. This investment in harmonized FLT3 testing simply would not have been possible in the absence of patent protection. And that patent protection continues.
About Invivoscribe Technologies, Inc.
Invivoscribe Technologies, Inc., a privately held company, is a world-leading provider of PCR and NGS-based molecular reagents, CE-marked IVDs, Analyte Specific Reagents, and RUO testing products and controls targeting the fields of hematology-oncology and hematopathology. Invivoscribe and its subsidiaries provide worldwide access to clinically validated, personalized molecular diagnostic products used to identify, classify and monitor leukemias, lymphomas and other lymphoproliferative diseases. Results from these tests enable doctors to optimize treatment for their patients.
Invivoscribe manufactures all of their products at their cGMP facility in San Diego, CA. Exclusive licensed patents protect a majority of Invivoscribe's products. Invivoscribe products are sold to more than 500 customers in over 50 countries directly from Invivoscribe (USA) and Invivoscribe SARL (France), as well as through a network of distributors worldwide.
About LabPMM LLC and LabPMM GmbH
Invivoscribe's CLIA- and CAP-accredited laboratory, LabPMM LLC (San Diego, USA), and LabPMM GmbH (Planegg-Martinsried, Germany) are the only reference laboratories in the world (ex-Japan) holding licenses to perform mutation testing for both the FLT3 and NPM1 biomarkers, which are covered by two different sets of patents. LabPMM clinical reference laboratories, both in the US and in Germany, use cGMP products manufactured by Invivoscribe for testing.
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Invivoscribe Technologies, Inc.
James B. Isaacs, Jr., J.D.
LabPMM LLC (USA):
A. Ross Cubbon, MS
Tel: +1 858-224-6650
LabPMM GmbH (EU):
Niels Adams, DPhil
Tel: +49 (0) 89 8994 80782
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