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NDA Partners Supports Successful EUA by FDA for Expedited Approval of COVID-19 At-home Diagnostic Test Kit
Date:6/4/2020

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.”

About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

About PrivaPath Diagnostics, Inc.
PrivaPath Diagnostics (“PrivaPath”) is the holding company for LetsGetChecked, a consumer-based diagnostics company developing an at-home health testing platform that connects customers to regulated laboratory testing to better manage and control one’s individual health. LetsGetChecked is making healthcare and diagnostics open and patient-led, empowering people to use technology in a simple but powerful way and giving consumers greater control over their personal health. The Company is headquartered in New York, New York, with tests covering general wellness, sexual health, women’s health and men’s health, and is available nationwide, as well as in Canada and Europe.

Contact
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle@ndapartners.com

Read the full story at https://www.prweb.com/releases/nda_partners_supports_successful_eua_by_fda_for_expedited_approval_of_covid_19_at_home_diagnostic_test_kit/prweb17167342.htm.


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