Genalyte Streamlines Immunogenicity Testing with Launch of MT-ADATM for Real-time Detection of Anti-drug Antibodies

Genalyte, Inc. announced the launch of its MT-ADATM anti-drug antibody (ADA) immunogenicity assay designed to run on the MaverickTM 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. “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.