Although the FDA has previously authorized COVID-19 diagnostic tests for at-home sample collection, it had never before granted Emergency Use Authorization (EUA) for an all-in-one diagnostic kit that allows people to test themselves for COVID-19 in their own home. But with cases surging, the agency made history on Nov. 17 by granting EUA to such a product from Emeryville, California-based Lucira Health. “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 Lucira At-Home Test Kit The Lucira COVID-19 All-in-One Test Kit is a single use test is based on 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 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 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 to allow 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 |
|---|
| Hologic | Clearance for HIV-1 viral load monitoring Aptima HIV-1 Quant Dx assay, first dual-claim assay for both diagnosis and viral load monitoring in US |
| Lucira Health | EUA for Lucira COVID-19 All-in-One Test Kit, first fully at-home test authorized for COVID-19 |
| GenScript Biotech | EUA for cPass SARS-CoV-2 Neutralization Antibody Detection Kit, first SARS-CoV-2 neutralizing antibody test to receive EUA |
| 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 |
New CE Marks & Global Certifications Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE| Manufacturer(s) | Product(s) |
|---|
| Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV rapid molecular diagnostic test |
| Zymo Research | Quick-DNA/RNA Viral MagBead Kit |
| Zymo Research | Quick SARS-CoV-2 Multiplex Kit |
| PerkinElmer | SARS-CoV-2 Real-time RT-PCR assay for use on saliva and sample pooling |
| Euroimmun (PerkinElmer) | Anti-SARS-CoV-2 QuantiVac ELISA test to quantify IgG antibodies |
| Tempus | xT, cancer genomic sequencing assay |
| PathoFinder | RespiFinder 2Smart kit for SARS-CoV-2 and Middle East respiratory syndrome-related coronavirus (MERS-CoV) testing |
| PathoFinder | RealAccurate Quadriplex (RAQ) Flu/COVID-19 PCR kit |
| Siemens Healthineers | Quantitative SARS-CoV-2 IgG antibody test |
| Bioneer | AccuPower RV1 Real-Time RT-PCR Kit and AccuPower RV1 Multiplex Kit combination tests |
| Hologic | Genius Digital Diagnostics cytology platform for cervical cancer screening |
| Qiagen | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test to identify and differentiate between seasonal respiratory infections and COVID-19 |
| Co-Diagnostics | Logix Smart SARS-CoV-2 multi-gene test, which detects both RdRp and E genes of virus |
| Co-Diagnostics | Logix Smart ABC assay, combination test for influenza A/B and SARS-CoV-2 |
| Ortho Clinical Diagnostics | Vitros Immunodiagnostic Products TSH3 reagent pack and calibrator |
| Biocartis | Idylla SARS-CoV-2 assay |
| Beckman Coulter | Access SARS-CoV-2 IgM assay |
| Credo Diagnostics Biomedical | VitaPCR Influenza A&B/SARS-CoV-2 combination test |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
|---|
| Sysmex | Japan | HISCL SARS-CoV-2 Ag Reagent test kit |
| Becton Dickinson | Canada | Health Canada approval for rapid point-of-care SARS-CoV-2 antigen test for use on BD Veritor Plus System |
