ROCHELLE, VA - NDA Partners Chief Executive Officer Earle Martin announced today that its client, PrivaPath Diagnostics, Inc. (also known as LetsGetChecked), successfully received an Emergency Use Authorization (EUA) from the FDA for LetsGetChecked Coronavirus (COVID-19) Test, a convenient, at-home diagnostic test kit for detection of the COVID-19 coronavirus (SARS-CoV-2). NDA Partners Expert Consultants provided regulatory advisory services to support the preparation and submission of the EUA. PrivaPath received notification of approval from the FDA in May.
Dr. David Feigal, Manager of NDA Partners’ medical device practice, praised PrivaPath’s accomplishment: “PrivaPath’s new diagnostic for home use will play an important role in addressing the public health challenges of COVID-19 and controlling its spread. We were pleased to support PrivaPath’s efforts and congratulate them on this significant contribution to personal and public safety. We look forward to supporting other companies developing critical medical products, diagnostic tests, and therapies to combat the COVID-19 pandemic.”