Diagnostic Products

CE-Marked in vitro diagnostic products (for sale and use outside North America)

Diagnostic Services

Our international reference laboratory, Laboratory for Personalized Molecular Medicine™ (LabPMM.com), is a CLIA- and CAP-accredited laboratory that provides clinical testing services. LabPMM is a wholly-owned subsidiary of Invivoscribe and is located in San Diego, CA.  This internationally recognized clinical laboratory is focused on Personalized Molecular Medicine™ and Personalized Molecular Diagnostics™.

All of LabPMM’s tests conform to the Standard of Care as defined by the World Health Organization and are recommended by members of the National Comprehensive Cancer Network, LeukemiaNet, and other world opinion leaders in hematology oncology.

The FLT3 & NPM1 Mutation Assays are recommended in both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) clinical practice guidelines. These tests are included as a Standard of Care for the majority of patient's diagnosed with AML. In patients diagnosed with acute myeloid leukemia (AML) mutations these two biomarkers are predictive of a patient's likelihood to benefit from chemotherapy and allogeneic stem cell transplantation. They also help predict the risk of experiencing cancer recurrence.

FLT3 & NPM1 Mutation Detection

LabPMM™ is the only reference laboratory licensed to perform testing to determine both FLT3 and NPM1 mutation status. We offer the NPM1 Mutation Assay and the FLT3 Mutation Assay tests as individual stand-alone tests, and 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 is present, and in cases where there is no FLT3 mutation, presence of the NPM1 mutation portends a more favorable outcome in CN-AML.