Diagnostic Products

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

Diagnostic Services

Our Laboratory for Personalized Molecular Medicine™ (LabPMM LLC), located in San Diego, California, is a CLIA- and CAP-accredited reference laboratory that provides services focused on personalized molecular medicine™, personalized molecular diagnostics™, and biomarker testing. While the majority of the specimens LabPMM LLC receives originate from customers in the US, LabPMM accepts samples from around the world.

In order to better serve pharma and the international community we are in the process of setting up a new reference laboratory, LabPMM GmbH, in district Planegg, in Martinsried, Munich, Germany. LabPMM GmbH was founded to be a replica of our clinical reference laboratory, LabPMM LLC.  For example, Standard Operating Procedures for all tests and business processes are identical, and employees at both sites will be hired, trained and supervised by the same personnel. Test reagents used in laboratories at both sites will be produced under GMP at our manufacturing facility in San Diego. Instrumentation, firmware and software will be as identical as is possible. Our goal is to set up a 'cloned' regional clinical laboratory for reference and clinical trials testing. LabPMM GmbH will be licensed and accredited to the ISO 15189 standard and is expected to start accepting clinical samples from customers in the EU starting early in 2011.

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™ are the only reference laboratories in the world licensed to perform testing to determine 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.