Xen Biofluidx Inc is a seasoned research and assay development team with over 65 years of combined assay development experience! For the last five years we have been providing contract design and development services to the life science and diagnostics community, with a focus on assay development, surface chemistry, and antibody engineering. We collaborate with leading scientists around the world to transform biomarker discoveries into reliable tools for the diagnosis and prevention of disease.
XenBio has an integrated product development approach: from protein expression, antibody development, surface and conjugation chemistry to a fully developed diagnostic test. We are also well versed in the practice of stabilizing biological reagents through formulation and lyophilization often required for assay integration. The company holds several proprietary, patent pending technologies that are unique to the point-of-care detection of biomolecules present in blood and other biological fluids at very low levels.
XenBio is proud to announce first-in-class Time Resolved Fluorescence (TRF) platform suitable for point-of-care use. In collaboration with its engineering partner Cambridge Consultants Ltd, XenBio has developed a high sensitivity point-of-care in-vitro diagnostic platform consisting of a proprietary TRF label, a one-step cartridge and a proprietary TRF instrument. At the core of this platform technology is a novel highly sensitive, patent pending label, developed by XenBio. Once excited, this label emits light over 500 microseconds. This allows one to illuminate it; turn off the light and then detect it in darkness. Any light detected must come from the label and not from the background. In addition it exhibits low non-specific binding due to its proprietary surface coating and is extremely bright due to harboring millions of dye molecules per single label. For these reasons, the label has very low background signal and very high signal-to-noise ratios allowing detection of molecules present in biological fluids at very low levels.
This label, when integrated with Cambridge Consultants’ patent-pending detection technology, provides a perfect launching pad for a variety of highly sensitive assays and low cost diagnostic devices providing the precision, accuracy and sensitivity expected of a clinical laboratory in a near patient setting. We have previously used this platform to demonstrate a sensitivity improvement of 10,000 fold over gold-label based assays, with excellent repeatability. The platform has repeatedly demonstrated sensitivity below 0.1pM which is amenable to further optimization. In addition to its high sensitivity, the platform has several other benefits. The low-cost and compact components offer the potential to place the platform at the core of highly commercially attractive low-cost rapid diagnostic systems. Our iHub instrument that houses the platform is capable of wireless transmission. This new universal wireless immunoassay platform was developed for a variety of biomarkers and can be applied retrospectively to traditional gold-based lateral flow systems to realize significant performance enhancements.
We are currently using this platform to develop a highly sensitive, CLIA-waived, point-of-care devices to for intraoperative use in parathyroid removal surgery. About 300,000 people in the United States per year are diagnosed with hyperparathyroidism (over activity of the parathyroid glands (PTG) resulting in excess production of parathyroid hormone (PTH)). The vast majority requires the surgical removal of one or more of the PTG. For successful and complete gland removal, PTH levels must be monitored in patients undergoing unilateral or bilateral neck exploration. Most PTH monitoring is currently done by a central laboratory, resulting in the patient spending additional time under anesthesia, the surgical team remaining with the patient while the PTH test is completed, and some uncertainty remaining about accuracy of the test due to short half-life of the hormone. For these reasons, there is a need for an inexpensive, intraoperative (point-of-care) diagnostic test for PTH. Our test is expected to be placed in a surgery room with the assay performed by any member of the surgical team with time to result less than 5 minutes...learn more