Kypha’s Precision Immune Monitoring (PIM) Systems

Kypha’s test systems generate reliable, precise clinical data on immune system dynamics by testing fresh, unprocessed samples quickly in virtually any setting.

Kypha's Platforms'

At Kypha we’re committed to providing reliable tests to to generate quality data for biomarkers of immune activity, including complement proteins and cytokines, on our single-analyte (Comp act) and multi-analyte (RapiPlex) test systems. Presently the systems are being used to support multiple internal and collaborative product development programs measuring a number of clinically important complement/immune biomarkers. Kypha is supplying on-site testing for patient screening and monitoring in biopharma clinical trials involving late-stage and on-market drugs for a variety of diseases. Our test systems also support collaborative work with an extensive network of leading clinical researchers and physicians. All of the above activities contribute to development of a comprehensive multiplex PIM panel that measure multiple biomarkers simultaneously in a single sample.

Both systems are designed and manufactured in accordance with FDA design controls in ISO13485 certified facilities.
Please note that Kypha’s Comp act and RapiPlex systems are currently available for research use only, pending regulatory approval.

By accurately measuring complement and other immune status biomarkers,
our systems can improve patient care and reduce unnecessary healthcare costs.

Comp act single analyte system

Comp act is designed to be a portable, easy to use, rapid system that delivers quantitative results, using minimal volume.

The tests are compatible with whole blood, plasma, serum, urine, cerebrospinal fluid, ocular fluids, and other biological specimen types. Additionally, the point-of-care test platform can accommodate lab, office, field or home use, and can easily support a variety of tests. The Comp act reader is produced in an FDA-audited facility with GMP manufacturing.

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Comp act(R) System

By accurately monitoring complement biomarker levels in the body we can focus on resolving its central role in immunity and inflammation.

RapiPlex multiplex test system

RapiPlex features highly sensitive fluorescence detection capable of simultaneous multiplex testing of up to 24 analytes from a single small volume sample (20-100 microliters) of whole blood, plasma, serum, urine, saliva, or other biological fluids.

Batch calibrations are loaded automatically for each cartridge using an innovative barcode system. Quantitative results are returned in 5-15 minutes and can be printed or uploaded to electronic databases or medical records.

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RapiPlex System

Shelf stable test formats and portable readers with low resource requirements make these systems easily deployable.

Sample Handling & Clinical Workflow Solutions

Kypha spent years studying clinical workflows in diverse settings from emergency rooms to intensive care units. Kypha is using its deep understanding of preanalytical factors impacting immune analysis to deliver reliable, scalable solutions for clinical trials and clinical practice.

In vitro instability of complement, cytokine, and chemokine analytes confounds immune analysis. Kypha’s clinical solutions and immune activation test systems are designed to standardize the entire sample workflow across diverse sites and preempt preanalytical variability. By solving this problem, Kypha’s systems can inform deep analysis of dynamic integrated immune activation processes with confidence in the raw data inputs and the insights they provide.

For more information on the status of this exciting project and tell us if you would like to participate in the clinical validation studies once development and manufacturing are completed, email us

The Kypha Offices in St. Louis

For more information and product specifications

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