Improving the Accuracy of Diagnostic Tests
The “Matrix Effect” limits the sensitivity, specificity and quantitative accuracy of diagnostic immunoassays. This results from interference caused by a litany of non-target agents in complex biosamples such as blood. This effect is especially problematic for the new generation of multiplex assays where a panel of biomarkers are simultaneously detected. PC-PURE™ utilizes photocleavable binding agents such as antibodies to capture only the target molecules in a patient sample, effectively eliminating the Matrix Effect.
AllerBead™ – A Revolution in Pediatric Allergy Testing
Based on PC-PURE™ technology, AmberGen has developed and is commercializing a low blood-volume, high-throughput, high sensitivity and quantitatively accurate system designed specifically for pediatric allergy testing (AllerBead™*). Using a single drop of blood, obtained through a heel-stick for infants or finger-stick for young children, AllerBead™ can accurately detect reactivity to up to 50 different allergens simultaneously. This is especially important for testing infants and young children for potential food allergies prior to implementing early consumption strategies recently shown to be effective in reducing the development of food allergies.
* Not currently available for commercial sale.
The ability to detect and diagnose diseases often depends on the discovery of new biomarkers. AmberGen’s novel technology provides a path for biomarker discovery that will help accelerate the development of new diagnostics. In one example of AmberGen’s successful Biomarker Discovery Program, two novel autoantigen biomarkers for the autoimmune liver disease PBC were discovered and validated under a Phase II SBIR grant from the NIAID-NIH. This work has led to the development of diagnostic assays comprised of these patented biomarkers which are currently undergoing FDA-clearance. In a second example, AmberGen’s technology is being applied to the discovery and implementation of diagnostic cancer biomarkers.
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Watertown, MA 02472
- AmberGen receives US Patent 9,910,034 increasing its broad coverage on PC-PURE™ photo-affinity biomarker purification and enrichment technology for improving the accuracy of diagnostic testing March 2018
- Paper published in PLOS ONE in collaboration with Boston Children’s Hospital “Photocleavage-based affinity purification of biomarkers from serum: Application to multiplex allergy testing” describing application of AmberGen’s PC-PURE™ to highly multiplex in vitro allergy testing (AllerBead™) February 2018