Quest Diagnostics Discovered Novel Adeno-associated virus (AAV) Test

Quest Diagnostics has discovered novel AAVrh74 ELISA assay, known as a CDx (companion diagnostic), designed for the semi-quantitative detection of IgG antibodies to AAVrh74 capsid in human serum.

This assay is designed to complement existing clinical information and assist in the selection of suitable candidates for treatment with ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy intended for specific individuals suffering from Duchenne muscular dystrophy.

Adeno-associated virus (AAV) vectors are engineered for therapeutic delivery, facilitating the transfer of genetic modifications into cells. They are widely studied for various therapeutic applications and stand as the leading viral gene delivery system in clinical trials.

Rare diseases, which encompass over 7,000 conditions, often result from defective genes, accounting for approximately 80 percent of these cases. Gene therapy aims to address these issues by delivering functional copies of missing or malfunctioning genes to the targeted cells. Current gene therapies are typically administered as one-time treatments.

Screening for pre-existing antibodies to AAV is crucial, as these antibodies can pose safety risks to patients and constrain the effectiveness of therapy. Evaluating the quantity of total binding antibodies (TABs) through testing is instrumental in identifying eligible patients for treatment.