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Inside the Lab Digital and computational pathology, Precision medicine, Software and hardware, Technology and innovation

Riding the Next Wave of Diagnostic Test Development with InSituPlex

sponsored by Ultivue

As a young startup company, Ultivue stands at the center of the ever-evolving world of biotechnology – charged with delivering new cures for diseases. Modern therapy development requires insight into mechanisms of disease and patient stratification strategies that will fuel the next wave of innovation in diagnostic testing. Ultivue is perfectly positioned to drive these discoveries – but how? It’s simple: InSituPlex. InSituPlex is a new, robust multiplex immunofluorescence assay technology, conjugating DNA barcodes to antibodies and using sequence-specific DNA-DNA hybridization to label antibodies in tissue sections. Multiplex detection is achieved through standard fluorescent slide scanners and can be analyzed with a wide variety of software. Multiplex detection has been used in research for several decades, but with limited uptake in diagnostic anatomic pathology. However, Keith Wharton, Vice President Medical Director at Ultivue and anatomic pathologist, says, “Rapid progress in the field of immuno-oncology and techniques such as single-cell phenotyping are creating an urgency around multiplex investigations with single-cell resolution that retain tissue context.” 

The past decade has witnessed the growth and maturity of these methods – but none are well-suited to the equipment and workflows commonly used in histology laboratories. InSituPlex assays can be automated on standard robotic autostainers in a workflow that mimics traditional immunohistochemistry. Furthermore, the InSituPlex nucleic acid hybridization-based signal amplification and detection means the tissue only needs to undergo mild antigen retrieval conditions during staining and restaining. This preserves tissue morphology and enables precise co-registration of multiplex images with the same H&E-stained tissue section used for pathologic diagnosis – allowing pathologists to correlate the appearance of every cell in the tissue section with its marker profile

By using DNA barcodes to amplify weak signals, InSituPlex assays generate a high signal-to-noise ratio that enables sensitive, robust detection of any marker used for conventional immunohistochemistry. Critical time savings are also achieved: first, assay development times are reduced from months (using traditional immunofluorescence methods) to two to three weeks; and second, assay run times on automated stainers are reduced from days to around five hours – you can go from marker discovery to optimized assay in just a few weeks! But remember, it’s not technology that’s driving the need to multiplex – it’s biology. Ultivue believes that tissue context is vital for accurate disease characterization and, given the growing need (especially in immuno-oncology) to associate the coexpression of multiple markers with specific cell phenotypes, InSituPlex is well-positioned for wider adoption by providing unparalleled insight into diseased tissues.

Ultivue’s current reagents and service offerings are for research use only, not for use in diagnostic procedures.

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