Invivoscribe Announces Collaboration Agreement to Develop Companion Diagnostic Test
Product News Feb 16, 2011
Invivoscribe™ Technologies, Inc., has announced 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.