FDA Watch

Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit

Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test kits have been cleared for home collection of samples. One of these products, Lucira Health’s COVID-19 All-in-One Test Kit which received EUA on Nov. 17, is an all-in-one COVID-19 diagnostic enabling people to test themselves in their own home. But even that product requires a prescription. On Dec. 15, the FDA took things to the next level by greenlighting a full at-home COVID-19 testing kit that can be sold over the counter.

The Ellume COVID-19 Home Test

The OTC product that broke this new ground is the Ellume COVID-19 Home Test, a rapid antigen test capable of detecting fragments of the SARS-CoV-2 virus. Although the assay is performed on samples taken from nasal swabs, it’s a Nasal mid-turbinate (NMT) test, which makes it less invasive than tests performed on samples taken using the much longer Nasopharyngeal (NP) swabs that require a trained a health care provider to administer.

More significantly, it’s an over-the-counter rather than a prescription test. Accordingly, FDA Commissioner Stephen M. Hahn, MD, hailed the approval as “a major milestone” in COVID-19 testing. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” Hahn suggests.

Costing about $30, the Ellume test kit includes a sterile nasal swab, dropper, processing fluid, and a Bluetooth-connected “Analyzer,” that pairs with an app providing step-by-step video instructions that users can upload to their smartphone. After the sample is analyzed, results are delivered to the user’s smartphone via Bluetooth in 15 minutes or less.

The test is pretty accurate, having correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms, according to the FDA. The test also correctly identified 91 percent of positive samples and 96 percent of negative samples in asymptomatic persons.

However, because antigen tests are generally prone to both false negative and positive results, the FDA recommends that patients who not displaying COVID-19 symptoms treat positive results as “presumptively positive until confirmed by another test as soon as possible.” This is likely to be particularly relevant for communities with fewer infections, because false positive results can be more common when antigen tests are used in populations where there’s low prevalence of COVID-19.

Here are the other key new FDA EUAs and international clearances announced in December:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Abbott EUA for Solana SARS CoV-2 rapid assay run on firm’s Solana instrument
Quidel EUA for Solana SARS CoV-2 rapid assay run on firm’s Solana instrument
Quidel EUA for MatMaCorp COVID-19 2SF Test run on firm’s Solas 8 portable nucleic acid analysis system
MatMaCorp. EUA for MatMaCorp COVID-19 2SF Test run on firm’s Solas 8 portable nucleic acid analysis system
Acon Laboratories EUA for Aptima SARS-CoV-2/Flu RT PCR assay
Hologic EUA for Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody test
Quanterix EUA for Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody test
Hologic Clearance for HIV-1 viral load monitoring Aptima HIV-1 Quant Dx assay, first dual-claim assay for diagnosis and viral load monitoring in U.S.
Genetworx EUA for Genetworx Covid-19 Nasal Swab Test including self-collection kit materials
PacificDx EUA for COVID-19 Test including use with nasal swab specimens self-collected at home using RapidRona’s self-collection kit
Ellume COVID-19 Home Test, first EUA for emergency COVID-19 test that can be completed at home without a prescription
Horiba Medical Clearance for Yumizen C1200 next-generation clinical chemistry system
Applied BioCode EUA for SARS-CoV-2 Assay expanded to include use with pooled samples
Siemens Healthineers EUA for over-the-counter version of firm’s Pixel by LabCorp COVID-19 Test Home Collection Kit
LabCorp EUA for over-the-counter version of firm’s Pixel by LabCorp COVID-19 Test Home Collection Kit
Mesa Biotech 510(k) clearance and CLIA waiver for Accula Strep A molecular test
Luminostics EUA for SARS-CoV-2 assay expanded to allow use with pooled samples
BioFire Defense EUA for SARS-CoV-2 assay expanded to allow use with pooled samples
Quest EUA for RC COVID-19 +Flu RT-PCR test for use with firm’s Self-Collection Kit for COVID-19 +Flu
Quest EUA for RC SARS-CoV-2 Assay, which is performed using Roche’s authorized Cobas SARS-CoV-2 RT-PCR test, expanded to include use with pooled samples
Rheonix EUA for SARS-CoV-2 assay expanded to include use on saliva samples
CDC EUA for CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel expanded to include use with pooled samples
Innovita Biological Technology EUA for Innovita 2019-nCoV Ab Test (Colloidal Gold) serology test
Cepheid EUA for Xpert Xpress SARS-CoV-2 DoD test for use by DoD-designated CLIA labs
Cepheid EUA for Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay run on firm’s Cobas E analyzers
Roche EUA for Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay run on firm’s Cobas E analyzers


New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product
Mologic COVID-19 Rapid Antigen Test
Abbott SARS-CoV-2 IgG II Quant antibody test run on firm’s Architect and Alinity I systems
Roche Cobas PIK3CA Mutation test for identifying metastatic breast cancer patients who may benefit from phosphoinositide 3-kinase (PI3K) targeted therapy
Roche Elecsys SARS-CoV-2 Antigen high-throughput test
Beroni SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)
Bruker FluoroType SARS-CoV-2/Flu/RSV winter respiratory virus panel
BioMérieux SARS-COV-2 Respi R-Gene multi-analyte panel test
Anitoa Systems Maverick portable qPCR instrument
Thermo Fisher Scientific TaqPath COVID-19, Flu A/B, RSV Combo Kit
GeneFirst COVID-19 Plus Detection Kit for detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus
EliTech Group SARS-CoV-2 Plus Elite MGB Kit
Eurofins Technologies GSD NovaGen SARS-CoV-2 rapid antigen test
Euroimmun EuroRealTime SARS-CoV-2/Influenza A/B PCR test
C2N Diagnostics PrecivityAD blood test for Alzheimer’s
Paige Paige Breast cancer detection software
LGC SeraCare Anti-SARS-CoV-2 controls kit
Solvd Health Genetic risk assessment test for opioid use disorder

 

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Agilent Technologies Japan GenetiSure Dx Postnatal Assay
Horiba Medical Canada HealthCanada approval for Yumizen C1200 analyzer
Oxford Immunotec South Korea Ministry of Food and Drug Safety approval for T-Cell Select reagent kit
Illumina China National Medical Products Administration approval for NextSeq 550Dx instrument
Fluidigm India Central Drugs Standard Control Organisation approval for Advanta Dx SARS-CoV-2 RT-PCR Assay
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