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Genalyte Launches Multiplexed Test Streamlining Immunogenicity Testing

Published: Tuesday, April 09, 2013
Last Updated: Tuesday, April 09, 2013
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Automated multi-tier ADA test combines screening, confirmatory and isotyping steps in a single assay.

Genalyte, Inc. has announced the launch of its MT-ADA™ anti-drug antibody (ADA) immunogenicity assay designed to run on the Maverick™ Detection System.

This test combines screening for the presence of ADAs and the characterization of each detected ADA with a full isotype profile.

With minimal required sample preparation and its combination of detection and characterization in a single assay, the MT-ADA assay streamlines ADA testing for both mouse and human samples, providing real-time detection without the use of dyes, fluorescent probes or radioactive labels.

Immunogenicity is triggered when the body generates an unwanted immune response to a drug. The resulting anti-drug antibodies can reduce the efficacy of the drug and cause a variety of harmful effects.

As a result, clinical testing of drug candidates to identify potential immunogenicity issues arising from anti-drug antibodies has become common. The new MT-ADA assay is designed for rapid, efficient and accurate ADA testing.

“Immunogenicity testing currently requires multiple steps and significant hands-on effort,” said Martin Gleeson, PhD, Chief Scientific Officer of Genalyte.

Gleeson continued, “MT-ADA simplifies and speeds up this process, combining the screening, confirmatory and isotyping steps in an automated assay that is efficient to develop and uses standard sample preparation methods. Early feedback from drug developers has been positive and we are pleased to now make the MT-ADA assay widely available to Maverick System users.”

The MT-ADA chip provides simultaneous ADA detection and confirmation for eight antibody classes/isotypes. The Maverick System’s multiplex capacity and kinetic measurement capability streamline assay development by enabling simultaneous assessment of assay sensitivity and free drug tolerance for total ADAs and for each antibody class.

The MT-ADA assay is compatible with commonly accepted sample preparation methodologies.

Genalyte’s Maverick Detection System uses a silicon chip containing arrays of photonic ring sensors that simultaneously analyze multiple antibodies and other proteins from a single small sample.

The one-step workflow of the Maverick Multiplex System can deliver accurate results in as little as 15 minutes from small volume samples of many types. The Maverick platform has a large dynamic range and excellent sensitivity with outstanding reproducibility.

Current commercially available tests for the Maverick Detection System include MT-ADA, ENA 4, ENA 6 and ANA 14 assay kits . Assay kits for SLE, Sjogren’s syndrome and type I diabetes research are available under Genalyte’s Technology Access Program.

Additionally, Genalyte offers researchers a Custom Spotting Service that loads proteins supplied by customers, such as antibodies, peptides, biomarkers, cytokines and antigens, on to standard-format Genalyte chips that are ready to be run on the Maverick System.

Learn more the Maverick Detection System and its multiplexed assays at the following upcoming conferences.

• PEGS 2013: The Essential Protein Engineering Summit, Boston, MA, April 29-May 3, 2013, Booth 115
• American Assoc. of Pharmaceutical Scientists (AAPS) National Biotechnology Conference, San Diego, CA, May 20-21, 2013, Booth 704
• Next Generation Protein Therapeutics Summit, San Diego, CA, June 25-27, 2013, Booth 6

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