FDA Watch

Agency Authorizes First Fully At-Home COVID-19 Testing Kit

With COVID-19 cases surging, the U.S. Food and Drug Administration (FDA) made history on Nov. 17 by granting Emergency Use Authorization (EUA) to an all-in-one COVID-19 diagnostic that allows people to test themselves in their own home. Although the agency has previously authorized COVID-19 diagnostic tests for at-home sample collection, this is the first time it has given the green light to a full at-home testing kit for the virus. “A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” noted Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

The At-Home Test

The product making the milestone is the Lucira COVID-19 All-in-One Test Kit from Emeryville, California-based Lucira Health. The single use test is based not on PCR technology but real-time loop-mediated isothermal amplification (LAMP) that operates at ambient temperatures to detect SARS-CoV-2 RNA from self-collected swab samples. Physicians prescribe the test for patients age 14 or above that they suspect have the virus. The assay runs on a handheld battery-powered device that looks like a thermometer and which provides a result via LED readout in 30 minutes or less. The EUA also allows for use of the test at the point of care in doctor’s offices, hospitals, urgent care and other CLIA-waived settings on samples collected by a healthcare provider.

According to the FDA, the Lucira test achieved 94 percent sensitivity and 98 percent specificity in a community testing study comparing the assay to an FDA-authorized SARS-CoV-2 test with known high sensitivity. Lucira adapted the test from a prototype it originally created for use as a flu test before pivoting in response to the COVID-19 pandemic.

Lucira says that it expects the test, which costs $50, to be available nationwide by the early spring. Lucira also plans to file for FDA approval for allowing the test to be prescribed through a telehealth visit, with the kit to be delivered by mail. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” noted FDA Commissioner Stephen Hahn in a statement.

LabCorp May Be Next

Meanwhile, testing giant LabCorp may soon up the ante by launching an at-home diagnostic of its own capable of detecting not only COVID-19 but also influenza and respiratory syncytial virus from a single sample making it perfectly suited for flu season. The new product, which will be offered through LabCorp’s Pixel service, will be an at-home version of the combined test currently provided in doctors’ offices, hospitals and other point of care settings.

Here are the other key new FDA EUAs and clearances announced from late October through late November:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Foundation Medicine Clearance for FoundationOne Liquid CDx test as companion diagnostic with olaparib (AstraZeneca and Merck’s Lynparza)
Quansys Biosciences EUA for Q-Plex SARS-CoV-2 Human IgG (4 Plex) immunoassay
DNA Genotek EUA for ORAcollect RNA ORE-100 and ORAcollect RNA OR-100 saliva collection devices for SARS-CoV-2 testing
LabCorp Reissued EUA for COVID-19 RT-PCR Test changing type of samples that can be used for pooled testing
Color Reissued EUA for loop-mediated isothermal amplification-based SARS-CoV-2 test allowing use on self-collected samples
PerkinElmer Reissued EUA for New Coronavirus Nucleic Acid Detection Kit allowing use for pooled samples
Roche Clearance for Cobas EGFR Mutation Test v2 as companion diagnostic for non-small cell lung cancer therapies
Agena Bioscience EUA for MassArray SARS-CoV-2 Panel
Merck Accelerated clearance for pembrolizumab (Keytruda) plus chemotherapy as treatment for locally recurrent, unresectable, or metastatic triple-negative breast cancer patients with high PD-L1-expressing tumors
Celltrion EUA for Sampinute COVID-19 Antigen MIA magnetic force-assisted electrochemical sandwich immunoassay
Foundation Medicine Clearance for FoundationOne Liquid CDx test as companion diagnostic for three new targeted cancer therapies, including alpelisib (Novartis’ Piqray) in advanced or metastatic breast cancer, rucaparib (Clovis Oncology’s Rubraca) in advanced ovarian cancer, and alectinib (Genentech’s Alecensa) in metastatic non-small cell lung cancer
Medicine Clearance for FoundationOne CDx test as companion diagnostic for use with larotrectinib (Bayer’s Vitrakvi) to identify cancer patients with neurotrophic receptor tyrosine kinase fusions
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