SARS-CoV-2 Laboratory-Developed Tests

Author:

Adashi Eli Y.1,Cohen I. Glenn2

Affiliation:

1. Department of Medical Science, Brown University, Providence, Rhode Island

2. Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Cambridge, Massachusetts

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference10 articles.

1. Regulation of laboratory-developed tests.;Genzen;Am J Clin Pathol,2019

2. Covid-19 molecular diagnostic testing—lessons learned.;Shuren;N Engl J Med,2020

3. Statement by HHS Secretary Xavier Becerra on withdrawal of HHS policy on laboratory-developed tests. November 15, 2021. Accessed December 16, 2021. https://www.hhs.gov/about/news/2021/11/15/statement-hhs-secretary-xavier-becerra-withdrawal-hhs-policy-laboratory-developed-tests.html

4. Preliminary findings of the subcommittee’s coronavirus antibody testing investigation. House of Representatives Committee on Oversight and Reform. To: Democratic Members of the Subcommittee on Economic and Consumer Policy. Subcommittee staff memorandum. April 24, 2020. Accessed December 16, 2021. https://oversight.house.gov/sites/democrats.oversight.house.gov/files/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf

5. Congressional Research Service. HHS announcement on FDA premarket review of laboratory-developed tests (LDTs). December 3, 2020. Accessed December 16, 2021. https://crsreports.congress.gov/product/pdf/IN/IN11548

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