Exosome Diagnostics Appoints Raaj Venkatesan as Vice President of Regulatory Affairs and Quality
Cambridge, Mass., Dec. 22, 2015 – Exosome Diagnostics, Inc., the developer of a revolutionary liquid biopsy platform that enables non-invasive diagnosis of serious diseases, aiming to reduce or eliminate the need for tissue biopsies, today announced the appointment of Raajdeep (Raaj) Venkatesan as its Vice President of Regulatory Affairs and Quality.
“I am honored to join Exosome Diagnostics at such an exciting time for the company and the liquid biopsy space,” said Raaj Venkatesan. “2016 will be a very busy year with the upcoming launches of our exosome-based liquid biopsy tests, and I look forward to working closely with our team and appropriate regulatory agencies to ensure the most effective deployment of our diagnostics to clinicians and pharmaceutical organizations. Additionally, I am particularly eager to leverage our recently launched ‘A to D’ program to partner with academic and clinical researchers to overcome obstacles in the regulatory and commercialization processes, which frequently prevent diagnostics from reaching patients in need.”
Raaj Venkatesan brings more than 10 years of experience in regulatory affairs, regulatory compliance and quality engineering in the medical device and In Vitro Diagnostics industry. Prior to joining Exosome Diagnostics, Raaj served as Director of Regulatory Affairs and Quality at Bio-Rad Laboratories, where he was responsible for leading the regulatory affairs and compliance for a next-generation sequencing in vitro diagnostic product. Prior to that, Raaj held various regulatory affairs and quality engineering positions at Bruker Daltonics, OmniGuide Surgical, Becton Dickinson (BD) Diabetes Care and Second Sight Medical Products. Raaj is Regulatory Affairs Certified (RAC-US, RAC-EU) by the Regulatory Affairs Professionals Society (RAPS) and is also an ASQ Certified Manager of Quality, Reliability Engineer, Quality Auditor, Biomedical Auditor and Quality Engineer. He earned his Master’s Degrees in Biomedical Engineering, Electrical Engineering and Medical Device and Diagnostic Engineering from the University of Southern California and Bachelor’s Degree in Electronics and Instrumentation Engineering from Bharathidasan University in India.
“The appointment of Raaj as the Vice President of Regulatory Affairs and Quality marks the beginning of the commercial stage for Exosome Diagnostics, as we prepare to commercialize our exosome-based diagnostics for lung cancer, prostate cancer and solid tumors,” said John Boyce, CEO of Exosome Diagnostics. “Raaj’s extensive regulatory affairs and quality assurance experience will help lead the company as we move towards regulatory approval for our tests. As Exosome Diagnostics begins providing these diagnostics as tools for healthcare providers to use in the clinic and for pharmaceutical companies to use in clinical trials, I look forward to working with Raaj to advance our diagnostics through the regulatory processes successfully, and, ultimately, to improve the lives of patients with cancer and other serious diseases.”
About Exosome Diagnostics
Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary, biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. The company’s novel exosome-based technology platform can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are detected, diagnosed, treated and monitored. Exosome Diagnostics is developing and plans to launch diagnostics in lung, solid tumor and prostate cancer in 2016. Visit www.exosomedx.com to learn more.
Feinstein Kean Healthcare