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