FDA Watch

Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. It has also accelerated the efforts to impose a modern, more transparent and workable system not only for the rest of the pandemic but the long-term future.

How FDA Regulates LDTs

Lab tests weren’t included in the original legislation that created the FDA and current regulatory system of medical drug and device regulation. So, the agency has relied on its powers to regulate devices. Accordingly, LDTs must obtain premarket approval through the 510(k) pathway for medical devices. In addition to challenging the FDA’s authority over LDTs, the lab industry has long objected to the agency’s practice of skirting the regulatory process and relying on guidance, website statements and other informal issuances to make regulatory policy.

The HHS Decision

As the crisis has deepened, the agency has found itself in the position of backing away from its hands-on approach and has allowed laboratories and test makers greater discretion in launching LDTs detecting the SARS-CoV-2 virus. And now a new Administration pronouncement carries that policy to a new and significant level. On Aug. 19, HHS announced that the FDA will no longer be able to regulate by informal decrees but will have to go through the customary notice and comment rulemaking process required for new regulations to regulate LDTs.

One result of the HHS decision, which is part of the Administration’s broader policy to cut government regulation over business, is that labs will now be able to offer LDTs for SARS-CoV-2 without going through the FDA’s Emergency Use Authorization (EUA) process. “Those with an active EUA to use an LDT to detect the virus causing COVID-19 or its antibodies are unaffected by this announcement,” HHS added.


The unexpected HHS announcement is the most recent in a series of efforts to rein in FDA regulation over LDTs. After several aborted attempts, last March, legislators in the U.S. House of Representatives and Senate reintroduced the Verifying Accurate Leading-edge IVCT Development Act (VALID) creating a new system for FDA review of in vitro clinical tests (IVCTs). VALID would establish a risk-based framework, with high-risk tests, like novel assays, required to go through premarket review; lower-risk tests could go to market after passing through technological certification. Key features of VALID:

  • Establishment of a technology certification program for lower-risk tests;
  • Requirement that high-risk tests undergo premarket review to verify analytical and clinical validity;
  • Authority of the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency; and
  • Creation of a new system to allow hospitals and laboratories to submit their tests electronically to the FDA for approval.

The law would also grandfather in existing LDTs being used clinically.

Here are some of the key FDA EUAs and clearances announced in August:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Fluidigm EUA for Advanta Dx SARS-CoV-2 RT-PCR assay, extraction-free saliva-based test
QDx Pathology Services EUA for QDX SARS-CoV-2 Assay, home collection kit
DxTerity Diagnostics EUA for DxTerity SARS-CoV-2 RT-PCR Test for use on saliva samples
Texas Department of State Health Services EUA for DSHS SARS-CoV-2 Assay
Guardant Health EUA for Guardant-19 RT-PCR, next-generation sequencing test
Streck De novo clearance for use of Cell-Free DNA BCT blood collection tube with Guardant Health Guardant360 CDx liquid-biopsy companion-diagnostic assay
LumiraDx EUA for LumiraDx SARS-CoV-2 Ag Test (third antigen test authorized for SARS-CoV-2)
LumiraDx EUA for LumiraDx SARS-CoV-2 RNA STAR assay
Sinochips Bioscience EUA for COVID-19 Nucleic Acid RT-PCR Test Kit
BioCheck EUA for BioCheck SARS-CoV-2 IgM and IgG Combo Test (serology)
23andMe 510(k) clearance for CYP2C19 Drug Metabolism Report, informing customers if their genotypes may influence their ability to respond to clopidogrel and citalopram without need for confirmatory testing
Diazyme Laboratories EUA for Diazyme DZ-Lite SARS-CoV-2 IgM test (serology)
Biomeme EUA for SARS-CoV-2 Real-Time RT-PCR Test
Solaris Diagnostics EUA for Solaris Multiplex SARS-CoV-2 Assay
Alpha Genomix Laboratories EUA for TaqPath SARS-CoV-2 Combo Assay based on Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit
George Washington University EUA for GWU COVID-19 RT-PCR test
BioMérieux EUA for Vidas SARS-CoV-2 IgM test used with firm’s Vidas SARS-CoV-2 IgG test (serology)
Beijing Wantai Biological Pharmacy EUA for Wantai SARS-CoV-2 Ab ELISA test (serology)
Helix EUA for next-generation sequencing-based test to detect SARS-CoV-2 spike protein gene
Guardant Health Clearance for Guardant360 CDx, targeted next-generation sequencing liquid biopsy assay, for tumor mutation profiling in advanced cancer patients with solid malignant neoplasm
Adaptive Biotechnologies Expanded clearance for its clonoSeq assay to assess minimal residual disease in patients with chronic lymphocytic leukemia
Roche Clearance for Cobas Epstein-Barr Virus test
Quest Diagnostics EUA for technique that speeds extraction of viral RNA from patient samples

New CE Marks & Global Certifications
Notable European CE certifications announced during the period:


Manufacturer(s) Product(s)
Natera Signatera personalized circulating tumor DNA test
Curetis SARS-CoV-2 Kit with PULB
Zymo Research Quick SARS-CoV-2 rRT-PCR kit
Antegenes Polygenic risk score (PRS) tests:
*AnteBC for breast cancer
*AntePC for prostate cancer
*AnteCRC for colorectal cancer
*AnteMEL for melanoma
Ender Diagnostics ender Mass PCR SARS-CoV-2 test
DiaSorin Liaison Testosterone xt test
NeuMoDx Molecular Quantitative BK virus (BKV) viral load monitoring assay
Snibe Diagnostics Maglumi SARS-CoV-2 S-RBD IgG serological assay
Yourgene Health Clarigene SARS-CoV-2 diagnostic kit
Abingdon Health AbC-19TM Rapid Test serological assay

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Yourgene Health Australia Therapeutics Goods Association approval of Iona Nx NIPT workflow as a Class 3 medical device

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