Invivoscribe, through its wholly-owned subsidiaries LabPMM, is a leading provider of clinically-validated personalized molecular diagnostics. We provide access to cutting edge testing to physicians and cancer centers world wide, enabling doctors to determine the most successful method of treatment for each patient. The company and its subsidiaries provide one stop comprehensive care for patients in over 50 countries. Invivoscribe's CE-marked IVD products are used to identify, classify and monitor leukemias, lymphomas and other lymphoproliferative diseases. The company's CLIA- and CAP-accredited clinical reference laboratories, LabPMM LLC & LabPMM GmbH, are the only clinical laboratories outside Japan licensed to perform FLT3 biomarker testing, and the only laboratories in the world licensed to determine the mutation status of both FLT3 and NPM1.

Products:

IdentiClone Gene Translocation Assays were developed and clinically validated by the EuroClonality/BIOMED-2 Group. These are in vitro diagnostic products intended for PCR-based detection of gene translocations in patients with suspect lymphoproliferations.

These standardized PCR-based tests include a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls.

Master mixes are composed of a buffered solution containing magnesium, deoxynucleotides, and primers that target the gene segments of interest.

Multiple primers are used to ensure a more comprehensive testing approach necessary to reliably identify clonal rearrangements.

These assay kits are complete, with the exception of Taq DNA polymerase. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training.

IdentiClone Gene Translocation Assays were developed and clinically validated by the EuroClonality/BIOMED-2 Group. These are in vitro diagnostic products intended for PCR-based detection of gene translocations in patients with suspect lymphoproliferations.

These standardized PCR-based tests include a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls.

Master mixes are composed of a buffered solution containing magnesium, deoxynucleotides, and primers that target the gene segments of interest.

Multiple primers are used to ensure a more comprehensive testing approach necessary to reliably identify gene translocations.

These assay kits are complete, with the exception of Taq DNA polymerase. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training.

LeukoStrat Gene Mutation Assays are in vitro diagnostic products intended for PCR-based detection of gene mutations in patients with acute myeloid leukemia (AML) and other lymphoproliferative diseases. These standardized PCR-based tests include a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls.

Master mixes are composed of a buffered solution containing magnesium, deoxynucleotides, and primers that target the gene segments of interest.

These assay kits are complete, with the exception of enzymes, which are identified by specific part number and vendor. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training.

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