FDA Sets New Limits on EUA Requests for COVID-19 Tests

The FDA’s policy on Emergency Use Authorization (EUA) for COVID-19 tests remains a work in progress. On Sept. 27, the agency posted a statement on its website declaring that current testing capacity is adequate and establishing limits on its review of new EUA submissions. Here’s a quick briefing of the new FDA policy.

The New Policy

More than 430 different COVID-19 tests have reached the US market via the EUA pipeline since the public health emergency began. Having achieved “sufficient testing capacity,” the agency expressed its belief that “most future submissions are best suited for traditional premarket review pathways,” i.e., De Novo classification or 510(k) clearance.

Accordingly, the agency says that from now on, it will “focus its review” on COVID-19-related EUA requests (and supplemental requests) from “experienced developers” for:

• Tests likely to have a significant public health benefit, such as tests using new technologies;
• Tests likely to fulfill an unmet need, such as tests diagnosing infection with new variants or subvariants;
• Supplemental EUA requests for previously authorized tests that are intended to fulfill a condition of authorization or include a modification that will significantly benefit public health or fulfill an unmet need; and
• Tests requested or supported by a federal government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).

EUA requests for COVID-19 tests that were in the pipeline before the new policy announcement “will remain in the queue,” the agency added.

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Here are some of the key new FDA EUAs and clearances that were announced in September 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
Oxford Immunotec (PerkinElmer subsidiary)	Clearance for T-Cell Select reagent kit automating sample preparation for firm's T-SPOT.TB interferon-gamma release TB screening test
Rheonix Inc.	Expanded EUA for COVID-19 MDx Assay to include home collection using firm’s COVID-19 PCR Test Saliva Home Collection Kit
Roche	510(k) clearance for its compact, modular testing system, Cobas pure integrated solutions
DiaSorin	510(k) clearance for Simplexa COVID-19 Direct Kit COVID-19 PCR assay delivering results in about an hour
Tasso	510(k) clearance for Tasso+ blood collection device as a Class II medical device
MagBio Genomics	510(k) clearance for MagXtract Collection Tube for viral sample collection
Quest Diagnostics	EUA for Monkeypox Virus Qualitative Real-Time PCR test

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Manufacturer(s)	Product(s)
Roche	Ventana PD-L1 (SP263) test as companion diagnostic for Regeneron's Libtayo (cemiplimab) in lung cancer patients
Roche	RT-PCR test for BK virus for use on Cobas 5800 instrument
Roche	RT-PCR test for Epstein-Barr virus for use on Cobas 5800 instrument
Roche	RT-PCR test for cytomegalovirus for use on Cobas 5800 instrument
Aleva Neurotherapeutics	directSTIM deep brain stimulation system for use with full-body magnetic resonance imaging (MRI) equipment
Qiagen	RT-PCR assay to detect and quantify Epstein-Barr virus on firm’s NeuMoDx instruments
Qiagen	RT-PCR assay to detect and quantify human herpesvirus-6 on firm’s NeuMoDx instruments
Siemens Healthineers	PCR-based FTD SARS-CoV-2/FluA/FluB/HRSV Assay combo test for differentiating SARS-CoV-2, influenza, and human respiratory syncytial virus infections
Siemens Healthineers	PCR-based Clinitest Rapid COVID-19 + Influenza A/B Antigen Test combo test for differentiating SARS-CoV- and influenza infections
Midge Medical	Minoo point-of-care (POC) reverse-transcriptase recombinase polymerase amplification (RT-RPA) for rapid detection of SARS-CoV-2, first commercial POC system to use RPA chemistries
Midge Medical	COVID-19 test for use on new Minoo system
SeekIn	OncoSeek Multi-Cancer Detection Test
MagBio Genomics	MagXtract Collection Tube for viral sample collection (which also received FDA 510(k) clearance)
Cardior Pharmaceuticals	CardiorHealth miR-132 Plasma PCR kit
BGI Genomics	Thalassemia Gene Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) detecting mutations that cause alpha- and beta-thalassemia
Owkin	Owkin Dx RlapsRisk BC test predicting risk of relapse after early breast cancer treatment
Owkin	Owkin MSIntuit CRC test to prescreen for microsatellite instability (MSI)
SkylineDx	Merlin Assay to predict which melanoma patients are at low risk of nodal metastasis
IncellDx	IncellKine assay for long COVID-19
Thermo Fisher Scientific	Oncomine Dx Express Test next-generation sequencing tumor mutation profiling test, and companion Oncomine Reporter Dx analysis software
Devyser	Quantitative fluorescent PCR-based test to detect aneuploidy in fetal cells circulating in maternal blood, amniotic fluid, and chorionic villus biopsy samples

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
Canhelp Genomics	China	Canhelp-Origin pan-cancer test and companion analysis software
Myriad Genetics	Japan	Expanded coverage for BRACAnalysis test as companion diagnostic to identify early-stage, germline BRCA-mutated and HER2-negative high-risk breast cancer patients who may benefit from AstraZeneca and Merck's Lynparza (olaparib)