LabPMM® is excited to announce the launch of the only internationally harmonized FLT3 Signal Ratio Assay.
Our FLT3 signal ratio (SR) assay tests for both ITD and TKD mutations, providing signal ratios for ITD mutations by comparing the signal intensity of the mutant and wild type amplicon products.
Our new AML Signal Ratio Panel incorporates ITD-SR with our current tests for FLT3 TKD and NPM1 mutations.
These assays provide a better understanding of the FLT3-ITD mutation burden in your patients, allowing for better patient stratification for treatment and monitoring. These internationally harmonized tests are being performed in our LabPMM laboratories, both in San Diego and Martinsried, Germany, using GMP reagents manufactured consistent with ISO13485 standards by our parent company, Invivoscribe, Inc.
LabPMM is happy to announce that we have received our New York state clinical lab license. We are currently accepting samples from New York. Please contact us with any questions.
If you or a loved one are an acute myeloid leukemia patient contemplating participation in a clinical trial that involves a drug that requires FLT3 testing, make sure you verify with your physician that your FLT3 test is being performed by LabPMM.
LabPMM is the only company properly authorized to generate a FLT3 result that can be used toward regulatory approval of a companion diagnostic and the FDA has made it clear that approval of any FLT3 targeted or stratified therapy requires an FDA-approved companion diagnostic.
July 17, 2013
Invivoscribe FLT3 Method Patent Claims Upheld
LabPMM is the only reference laboratory licensed to perform testing to determine FLT3 and NPM1 mutation status. We offer both the NPM1 Mutation Assay and the FLT3 Mutation Assay tests individually or together as an AML Mutation Panel.
Assessment of FLT3 mutation status in cytogenically normal AML (CN-AML) is the single most important prognostic indicator of disease outcome.
NPM1 mutation status has been determined to confer some protection in cases where the FLT3 mutation exists and, in cases where there is no FLT3 mutation, presence of the NPM1 mutation portends a more favorable outcome in CN-AML.
The Laboratory for Personalized Molecular Medicine® (LabPMM), a CLIA- and CAP-accredited international clinical reference laboratory, is located in San Diego, CA. LabPMM is a wholly-owned subsidiary of Invivoscribe Technologies, Inc. Our test menu is focused on Personalized Molecular Medicine™ and Personalized Molecular Diagnostics™.
The FLT3 and NPM1 mutation tests performed by LabPMM are standard of care for AML according to the World Health Organization and the National Comprehensive Cancer Network. LabPMM provides high quality testing for leading cancer centers and major reference labs worldwide.
With locations in both San Diego and Martinsried Germany, LabPMM ensures that we can provide consistent and reproducible results worldwide. Please contact us for more information on how our worldwide presence can help your project.