IVDR Transition Program

About InVivoScribe

Founded in 1999 and headquartered in San Diego, CA, InVivoScribe has established itself as a pioneer in precision diagnostics for hematologic malignancies. The company operates a dual business model, offering both a portfolio of regulated diagnostic products (CE-IVD, IVD) and a global network of CLIA-certified clinical laboratories (LabPMM). Its core strength lies in its proprietary assays for biomarkers like FLT3 and NPM1, its role as a streamlined CDx development partner for pharma, and its leadership in MRD testing, positioning it at the intersection of diagnostics, personalized medicine, and drug development support.

About Empire Genomics

Empire Genomics is a leading provider of FISH probe technology, serving the clinical diagnostics and research markets with a broad catalog of standardized and custom probes. The company's core strength lies in its extensive BAC clone library and its ability to deliver custom probe designs within two weeks, supported by stringent quality control. It has successfully expanded its portfolio to include automation-compatible probes and ancillary reagents, positioning itself as an integrated solutions provider in the cytogenetics and molecular pathology space. With a commercial business model, Empire Genomics generates revenue through product sales and services, supplying major cancer centers globally.

Therapeutic Areas