SAN DIEGO, CA--(Marketwire - February 15, 2011) - Invivoscribe™ Technologies, Inc.
, a world leader in personalized molecular medicine, announced today that they have entered into a collaboration agreement with Novartis
to develop and commercialize a companion diagnostic test. The test aims to identify FLT3 positive acute myeloid leukemia (AML) patients for specific use in connection with the Novartis development compound, midostaurin (PKC412). Midostaurin, a targeted small molecule inhibitor of FLT3 tyrosine kinase, is currently in Phase III clinical development for newly diagnosed patients with FLT3 mutated AML who are receiving midostaurin or a placebo in combination with chemotherapy (NCT00651261). FLT3 is mutated in approximately one-third of all AML patients and FLT3 mutations are associated with poor prognosis.
The American Society of Clinical Oncology® and the National Comprehensive Cancer Network® recommend testing for the FLT3 mutation in all patients diagnosed with AML -- determination of FLT3 mutation status has become a standard of care for patients diagnosed with AML. The Laboratory for Personalized Molecular Medicine (LabPMM™), a subsidiary of Invivoscribe, is currently the only clinical laboratory with an exclusive license to the patents required to generate a FLT3 result that can be used toward regulatory approval of a companion diagnostic.
"Developing an FDA-approved FLT3 companion diagnostic for midostaurin will be a significant milestone for our companies, Invivoscribe and LabPMM," said Dr. Jeffrey E. Miller, founder, chief scientific and chief executive officer of Invivoscribe and LabPMM. "We are delighted to collaborate with one of the world's leading healthcare companies in a manner that enables us to leverage our expertise in both molecular diagnostic product development and personalized molecular medicine."
Invivoscribe and LabPMM will develop, manufacture and work with the Novartis Molecular Diagnostics (MDx) unit to obtain regulatory approval for the companion diagnostic. Invivoscribe and Novartis MDx will then work together to make the companion diagnostic for treatment of AML available throughout the world.
Acute myeloid leukemia is one of the most common types of leukemia among adults according to data from the Leukemia and Lymphoma Society®. AML results from genetic alterations in normal hematopoietic stem cells and is defined as more than 20% blasts in the bone marrow, which suppresses the growth of normal hematopoietic cells leading to pancytopenia (low levels of red blood cells, white blood cells and platelets). AML afflicts approximately 13,000 new patients in the United States every year and approximately 30,000 new patients around the world. AML is predominantly a disease of the elderly (median age at diagnosis is 66 years); the incidence increases with age, but it is also the leading cause of cancer death in patients less than 20 years of age. FLT3 mutations occur in up to 30% of adult AML patients and these mutations are associated with poor prognosis leading to significantly shorter survival and a higher incidence of relapse. Patients with FLT3 mutated AML represent an area of high unmet need because there are few treatment options. The current standard of care for treatment of FLT3 mutated AML includes chemotherapy, stem cell transplant and palliative care.
About Invivoscribe Technologies, Inc.
Invivoscribe Technologies, Inc. (IVS), a privately held company, is a world leading provider of PCR-based molecular reagents, CE-marked IVDs, Analyte Specific Reagents, and RUO testing products and controls targeting the fields of hematology-oncology and hematopathology. IVS and its subsidiaries provide worldwide access to clinically validated, personalized molecular diagnostic products, which are used to identify, classify and monitor leukemias, lymphomas and other lymphoproliferative diseases. Results from these molecular tests enable doctors to determine and recommend the most successful method of treatment to their patients with cancer.
Invivoscribe manufactures their products in San Diego, CA, at their GMP facility. The majority of Invivoscribe's products are protected by exclusive licensed patents. IVS products are currently sold in over 50 countries to clinical laboratories directly from Invivoscribe (USA) and Invivoscribe SARL (France), as well as through a network of distributors worldwide. For more information, please visit http://www.invivoscribe.com.
About LabPMM LLC and LabPMM GmbH
Invivoscribe's CLIA- and CAP-accredited laboratory, LabPMM LLC, is the only reference laboratory in the world authorized to perform mutation analysis on both the FLT3 and NPM1 biomarkers. Invivoscribe has recently started a laboratory in Planegg-Martinsried, Germany, to provide FLT3 and NPM1 testing for customers throughout Europe. LabPMM GmbH expects to be accredited and ready to accept samples later this year. LabPMM clinical reference laboratories, both in the US and in Germany, use IVS products exclusively. For more information, please visit http://www.labpmm.com.