FDA Recognizes Quest Diagnostics AAV Test with Breakthrough Designation

Thursday, August 31, 2023

Quest Diagnostics, a leading provider of diagnostic information services in the United States, has announced that its AAVrh74 ELISA assay (CDx) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The FDA's Breakthrough Device Designation is a process designed to accelerate the development and review of medical devices and device-led combination products that have the potential to provide more effective treatment or diagnosis for life-threatening diseases or conditions that are irreversible.

The AAVrh74 ELISA assay is an in vitro diagnostic test that utilizes enzyme-linked immunosorbent technology. It is designed to semi-quantitatively detect antibodies (IgG) to the AAVrh74 capsid in human serum. The purpose of the test is to be used alongside other clinical information to help identify patients who could benefit from Sarepta Therapeutics' ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy intended for certain individuals affected by Duchenne muscular dystrophy. Additionally, Quest Diagnostics and Sarepta have announced an expanded collaboration. As part of this collaboration, Quest will develop companion or complementary diagnostics for Sarepta's range of gene therapies, including screening assays for antibodies related to AAV-vector based gene therapies for muscular dystrophies like Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMD).

The achievement of Breakthrough Device Designation for the AAVrh74 ELISA assay and the collaboration with Sarepta, a leader in AAV-based gene therapies, positions Quest Diagnostics at the forefront of innovation in companion diagnostics within the evolving field of gene therapies.

AAV-Based Gene Therapies: A significant percentage, around 80%, of over 7,000 rare diseases are caused by genetic defects. The primary objective of gene therapy is to deliver functional copies of missing or faulty genes to targeted cells. Current gene therapy approaches involve one-time treatment.

Adeno-associated virus (AAV) vectors can be engineered to act as carriers for therapeutic delivery, transporting beneficial genetic modifications into cells. AAV vectors are being explored for various therapeutic applications and are the most commonly used viral gene delivery systems in clinical trials. Given the potential risks posed by pre-existing antibodies to AAV, which can impact patient safety and treatment effectiveness, patients need to undergo antibody screening to determine their eligibility. Testing to measure the presence of total binding antibodies (TABs) plays a crucial role in identifying eligible patients.




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