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Avrobio, Saladax Biomedical Partner on Busulfan Monitoring Assay

NEW YORK — Gene therapy developer Avrobio said on Monday that it has partnered with Saladax Biomedical to develop and commercialize an automated nanoparticle immunoassay kit for busulfan therapeutic drug monitoring (TDM).

Busulfan is a chemotherapeutic used as conditioning agent prior to hematopoietic stem cell transplants, which are used in Avrobio's investigational therapies. It is also used to treat certain kinds of leukemias.

According to Avrobio, current busulfan TDM assays can take hours to provide results and must be processed at specialized laboratories. Bethlehem, Pennsylvania-based Saladax is developing a blood-based assay kit that can return results on patient metabolization of busulfan in minutes using standard analytical devices.

Avrobio will provide funding to support development of the assay, but Saladax will retain all product rights, according to an Avrobio spokesperson. Additional terms of the companies' agreement were not disclosed.

"We believe this new assay kit will, for the first time, provide convenient busulfan TDM close to the patient, potentially improving both the patient experience and long-term outcomes, as well as enabling many more hospitals and clinics to become TDM-capable sites," Avrobio President and CEO Geoff MacKay said in a statement.