FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for Friedreich ataxia.
DURHAM, NC, UNITED STATES, February 10, 2026 /EINPresswire.com/ — BioAgilytix Labs, Inc, the global leader in bioanalysis, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its plate-based MSD anti-adeno-associated virus serotype rh.10 (AAVrh.10) total antibody (TAb) assay, developed to support Lexeo Therapeutics, Inc.’s gene therapy program associated with Friedreich ataxia (FA) cardiomyopathy, a rare and progressive multisystem disorder affecting approximately 15,000 individuals worldwide.
The FDA’s Breakthrough Device Designation is intended to expedite the development, assessment, and review of novel medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. Devices granted BDD may benefit from enhanced FDA interaction and guidance, priority review, and a more efficient path toward potential market access.
“Receiving Breakthrough Device Designation for this assay highlights the scientific rigor and clinical relevance of our bioanalytical development capabilities,” said Davide Molho, Chief Executive Officer of BioAgilytix. “This designation highlights the critical role high-quality bioanalytical assays play in advancing gene therapy programs and reflects our commitment to working closely with sponsors and the FDA to help accelerate patient access to transformative therapies.”
This designation underscores the assay’s potential to address an unmet clinical need by enabling precise patient selection and monitoring for emerging gene therapy programs. As one of a limited number of Contract Research Organizations (CROs) to receive BDD for a diagnostic assay supporting an investigational device exemption (IDE), BioAgilytix continues to demonstrate leadership in regulatory-compliant bioanalysis for advanced therapeutic modalities requiring robust immunogenicity assessment.
“As sponsors push the boundaries of innovation in gene therapy, robust and reliable bioanalytical assays are essential,” added Linda Robbie, Chief Operations Officer. “We are proud to partner with Lexeo Therapeutics and to support programs that aim to address significant unmet medical needs.”
About BioAgilytix
BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit www.bioagilytix.com.
Kaitlyn Kitzman
BioAgilytix
+1 919-381-6097
email us here
Visit us on social media:
LinkedIn
Legal Disclaimer:
EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
