To date, only two exosome-based diagnostics have gained FDA’s Fast Track Approval. One is Exosome Diagnostics/Bio-Techne’s ExoDx Prostate IntelliScore (EPI) test. The Breakthrough Device Designation was awarded on June 17, 2019. By granting the designation, FDA has acknowledged the need to avoid a painful and invasive prostate biopsy. The second diagnostic was Guardant Health’s Guardant360CDx, approved by the U.S. FDA on August 13, 2020. It is an exosome-based diagnostic that can detect metastatic non-small cell lung cancer (NSCLC). [Read more…]

Exosomes have incredible properties that enable researchers to engineer exosomes as carriers for the delivery of drugs and target tissues of interest, while evading or modulating immune responses. Drug delivery and development of exosome-mediated therapies is a growing market segment, with over 50 companies forging ahead in this field. All the recent advances in exosome research are technology-based and this helps researchers to quantify exosome cargoes and subtypes, allowing for the tracking of exosomes with remarkable precision. This is helping companies to regulate exosome drug dosage and delivery, as well as deliver effective treatments for hard-to-treat diseases, such as cancer and neurodegenerative diseases. [Read more…]