The European Commission Approves Astellas’ XOSPATA® for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation Detected by Validated Tests, including the Invivoscribe LeukoStrat CDx FLT3 Mutation Assay

SAN DIEGO, Dec. 05, 2019 (GLOBE NEWSWIRE) -- For twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. The LeukoStrat^® CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA^® (gilteritinib) in Europe. FLT3 mutation must be confirmed with a validated test, such as the LeukoStrat CDx FLT3 Mutation Assay, which served as the companion diagnostic in the Phase 3 ADMIRAL trial resulting in approval of XOSPATA^®.  

Companion diagnostics play a key role in the development and approval of targeted drug therapies. The ability to screen for biomarkers in a patient population creates patient subsets which further enables drug developers in the design of novel therapeutics and management of clinical trials. Accordingly, the successful approval of a targeted therapy is highly dependent on the performance of the companion diagnostic.

EC approval of gilteritinib is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. The ADMIRAL study demonstrated that gilteritinib resulted in a statistically significant improvement in median overall survival (9.3 months) compared to salvage chemotherapy (5.6 months) when patients were selected with the LeukoStrat CDx FLT3 Mutation Assay (Hazard FLT3 Ratio = 0.637 (95%CI 0.488, 0.830, P=0.0004). This approval highlights yet another solution in patient care.

About LeukoStrat CDx FLT3 Mutation Assay
This PCR-based, in vitro diagnostic test detects internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML. This test, which is available worldwide, includes software that interprets data, generates standardized mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to multiple tyrosine kinase inhibitors.

Global Services and Distributable Kits
The LeukoStrat CDx test is currently available as a test menu service through Invivoscribe’s wholly-owned subsidiaries, LabPMM LLC (US), LabPMM GmbH (Germany) and LabPMM GK (Japan). LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, Europe, and Australia, are under review for distribution in the US, and are planned for distribution in China.

About Invivoscribe
Invivoscribe is a global biotechnology company dedicated to Improving Lives with Precision Diagnostics^®. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. For additional information please contact Invivoscribe at: [email protected] or visit: www.invivoscribe.com.