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® Laboratories) are ISO 15189-accredited international reference laboratories focused on providing clinical testing in support of Personalized Molecular Medicine® and Personalized Molecular Diagnostics®. There are currently two such laboratories serving partners in both the USA and in Europe and a third fully-accredited laboratory is in the process of being setup in Japan. Together they will form an internationally harmonized group of ISO 15189 accredited laboratories providing standardized results worldwide.
LabPMM LLC is located in San Diego, California. It is an ISO 15189, CLIA-, and CAP-accredited, New York State Licensed international reference laboratory.
LabPMM GmbH is based in Martinsried, Munich, Germany. It is an ISO 15189 accredited international reference laboratory.
LabPMM's test menu is focused on biomarkers that have demonstrated clinical utility, provide data and information that is clinically actionable, and are critical to making informed treatment decisions. These tests conform to the standard of care defined by the World Health Organization and they are recommended by members of the National Comprehensive Cancer Network, the LeukemiaNet, and world opinion leaders in hematology-oncology.
Accordingly test results generated by LabPMM® are relied upon daily to help determine the treatment decisions made by healthcare providers and medical centers in consultation with their patients.
Explore LabPMM's dedicated website for further information on LabPMM's services.