Agency Unveils Guidance for Full Approval of SARS-CoV-2 Tests

Even though the COVID-19 public health emergency (PHE) can’t last forever, according to US chief medical advisor Dr. Anthony Fauci, coronavirus may never completely disappear from the face of the earth. And that means that producers of tests detecting the SARS-CoV-2 virus should expect to be in it for the long haul. With that in mind, the FDA released draft guidance on making the transition from Emergency Use Authorization (EUA) to full marketing and regulatory approval.

SARS-CoV-2 Tests Have Traveled the EUA Pathway

Because SARS-CoV-2 was a totally unknown virus, there were no tests designed to detect it when the PHE began. As a result, FDA authorized, and continues to authorize, SARS-CoV-2 tests on an emergency basis using its authority (under Section 564 of the Food, Drug & Cosmetics Act) to authorize unapproved products in the event of an emergency. Since the PHE began, more than 300 SARS-CoV-2 diagnostic products have reached the US market via the EUA pathway. EUA authorization remains valid for as long as the PHE that prompted it remains in effect. While it seems unimaginable that this PHE will ever come to an end, some form of normalcy is bound to return sooner or later. So, if the virus is still around when the Department of Health and Human Services (HHS) declares an end to the COVID-19 PHE, there may not be enough fully authorized tests that labs can use to diagnose it.

From EUA to Full Regulatory Approval

The point of the new FDA draft guidance is to prevent disruption of test supplies and provide for an orderly and timely transition from PHE to normal operations. The guidance says that SARS-CoV-2 tests with EUA approval produced by manufacturers that don’t intend to seek full marketing approval and that have already been distributed may be used for two years after the EUA termination date, or until they expire. But the key part of the guidance is addressed to manufacturers who do plan to seek full approval for their tests. FDA calls on those manufacturers to include in their submissions a transition plan for dealing with products they’ve already distributed. The transition plan should include:

• The estimated number of tests currently in distribution in the US;
• An explanation of how the manufacturer will dispose of products that it’s already distributed if FDA denies its application for marketing approval; and
• An explanation of how the manufacturer will deal with previously distributed products if FDA approves the marketing submission.

If the manufacturer proposes to leave the already distributed products in place, the transition plan should explain the rationale for doing so and set out a process for notifying providers, health care facilities, distributors, patients and consumers of the product’s regulatory status. The guidance also says the plan should provide for what happens if a submission is denied—with already distributed products left on the market—by including a process and timeline for both restoring those devices to the previously FDA-cleared or approved version and “providing publicly available labeling that accurately describes the product features and regulatory status.” The plan should also include a maintenance plan for distributed products. In addition, there should be a process and timeline for providing users updated labeling or components reflecting changes made to the product if a marketing submission is approved, according to the guidance. If the manufacturer has submitted its test for marketing approval and had it accepted by the FDA before the EUA termination date, the guidance adds, the test may continue to be distributed, with updated labeling, until the agency reaches a final decision. Here are some of the key new FDA EUAs and clearances announced in December 2021:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
GenBody America	Expanded EUA for use of GenBody COVID-19 Ag antigen test kit for testing asymptomatic individuals
University of California, San Diego	EUA for UCSD EXCITE COVID-19 Test at EXCITE labs
Applied BioCode	EUA for BioCode CoV-2 Flu Plus Assay
Nano-Ditech	EUA for point-of-care Nano-Check COVID-19 Antigen Test
Pattern Bioscience	Breakthrough device designation for Pneumonia Action Panel
Thermo Fisher Scientific	Premarket approval for Oncomine Dx Target Test as companion diagnostic for Janssen Biotech’s targeted lung cancer treatment amivantamab-vmjw (Rybrevant)
Opko Health	510(k) clearance for 4KScore prostate cancer test
Foundation Medicine (Roche)	510(k) clearance for FoundationOne CDx as companion diagnostic for two groups of BRAF inhibitor therapies for melanoma
Audere	EUA for The HealthPulse@home kit for self-collection of anterior nasal swab specimens
Immunexpress	510(k) clearance for SeptiCyte RAPID sepsis assay
Qiagen and DiaSorin	510(k) clearance for LIAISON QuantiFERON-TB Gold Plus assay for latent tuberculosis testing on DiaSorin’s LIAISON XS benchtop platform
Siemens Healthineers	510(k) clearance for Atellica CH Enzymatic Creatinine 3 (ECre3) assay for quantitative determination of creatinine
Roche	510(k) clearance for Cobas Cdiff real-time PCR nucleic acid test run on firm’s Cobas Liat point-of-care system
Abbott Laboratories	510(k) clearance for BCG2 assay for quantitation of albumin
BioMérieux	510(k) clearance for ETest Fosfomycin manual assay for antimicrobial susceptibility
BioMérieux	510(k) clearance for BioFire COVID-19 Test 2
Becton Dickinson	510(k) clearance for Kiestra IdentifA specimen preparation system and BD Kiestra Laboratory Automation Solution
InBios International	EUA for SCoV-2 Ag Detect Rapid Self-Test, over-the-counter SARS-CoV-2 home antigen test

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

Manufacturer(s)	Product(s)
LumiraDx	Point-of-care SARS-CoV-2 & Flu A/B Antigen Test
Avacta	AffiDX SARS-CoV-2 antigen assay for use as consumer self-test
Becton Dickinson	MX, a new instrument component of firm’s BD Cor system
Roche	Cobas SARS-CoV-2 Qualitative test for use with saliva samples
Roche	Four molecular infectious disease tests for use on firm’s new Cobas 5800 instrument
Roche	Combo SARS-CoV-2 and influenza A/B rapid antigen test
Eurobio Scientific	EBX 047 test, Eurobioplex SARS-CoV-2 Fast Screening and Variants Detection (SVD)
Genedrive	Rapid point-of-care molecular COVID-19 test
Euformatics	OmnomicsNGS variant interpretation and reporting software
Qiagen	QuantiFeron SARS-CoV-2 assay
DNA Script	Syntax enzymatic DNA synthesis platform

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
Becton Dickinson	Australia	MX, a new instrument component of firm’s BD Cor system
CoSara Diagnostics	India	Saraplex Flu A/Flu B/COVID-19 (ABC) multiplex RT-PCR test
Chembio Diagnostics	South Africa	DPP SARS-CoV-2 Antigen test
Novacyt	UK	Genesig COVID-19 Real-Time PCR assay