FDA Authorizes First Over

Date: MAY.1.2023 // Source: Clinical Laboratory News

The Food and Drug Administration (FDA) recently issued an emergency use authorization (EUA) for the first over-the-counter at-home diagnostic test that can differentiate and detect influenza A and B and SARS-CoV-2.

The Lucira COVID-19 & Flu home test is a single-use kit that provides results in roughly 30 minutes. The test can be purchased without a prescription and performed completely at home using nasal swab samples self-collected by individuals ages 14 years or older or by an adult for individuals 2–14 years of age.

In individuals with symptoms, the Lucira COVID-19 & Flu home test correctly identifies 99.3% of negative and 90.1% of positive influenza A samples, 100% of negative and 88.3% of positive SARS-CoV-2 samples, and 99.9% of negative influenza B samples. Because of insufficient circulating influenza B cases to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens. The EUA requires Lucira to continue to collect samples to study the test's ability to detect influenza B in real-world settings.

In the wake of this authorization, FDA officials said that they recognize the benefits of home testing and that the agency will continue to use its authority to increase the number of accurate and easy-to-use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses.

BD has received Food and Drug Administration market approval for the BD Onclarity HPV assay to be used with Hologic's ThinPrep Pap test.

The BD Onclarity HPV assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis. The assay reports genotypes beyond HPV types 16, 18, and 45, including types 31, 51, 52, 33/58, 35/39/68, and 56/59/66, making the test the only FDA-approved assay to individually identify and report these genotype results. The test also has approval for use in women who have received the HPV vaccine.

The ThinPrep Pap test combined with the BD Onclarity HPV assay can be used on the BD COR or BD Viper LT instrument platforms without the need to change current cytology equipment.

Cepheid has earned Food and Drug Administration emergency use authorization for Xpert Mpox, which runs on Cepheid's GeneXpert systems. This test for the monkeypox virus is authorized for use in settings operating under a CLIA certificate of waiver, certificate of registration, certificate of accreditation, or certificate of compliance. These include moderately complex settings and point-of-care settings. The test requires less than 1 minute of hands-on time and no specimen prep. Users obtain swab samples in viral transport medium/universal transport medium, transfer samples to a cartridge, then insert the cartridge in a GeneXpert instrument and start the test. The test then provides results in approximately 36 minutes.

The Food and Drug Administration has granted LumiraDx an emergency use authorization (EUA) for the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay, which has also been validated by the U.K. Health Security Agency under the Coronavirus Test Device Approvals process. Under this EUA, high-complexity laboratories can use the test to simultaneously detect and differentiate influenza A, influenza B, and SARS-CoV-2 infections within 20 minutes or less. The assay uses qSTAR technology, which utilizes a single-step direct method for nucleic acid extraction and amplification on validated open reverse transcription PCR instruments.

Spectrum Solutions has secured Food and Drug Administration 510(k) clearance for its SDNA Saliva Collection Device. Spectrum designed this device with the goal of solving the most common points of failure associated with detecting viral infections using whole saliva. Cleared as a microbial nucleic acid storage and stabilization device, SDNA maximizes detection of viruses at low levels and neutralizes them within 10 seconds of collection to minimize unnecessary exposure. The device also features a patented preservation media that keeps analytes stable at ambient temperatures for several weeks.

The Food and Drug Administration has granted bioMérieux 510(k) clearance and a CLIA waiver for its Biofire Spotfire system and its Biofire Spotfire Respiratory panel. The panel detects 15 of the most common bacteria, viruses, and viral subtypes that cause respiratory tract infections. It is intended for use in patients with symptoms of these infections, and it delivers results in approximately 15 minutes, enabling patients to get diagnoses during the course of clinician visits.

bioMérieux added that it will submit a 510(k) application for the Biofire Spotfire Respiratory Panel Mini, noting that clearance of this test will also help the company expand its syndromic testing technology beyond traditional clinical laboratories to urgent care and physician offices.

Anavasi Diagnostics has received Food and Drug Administration emergency use authorization for its point-of-care AscencioDx COVID-19 test and AscencioDx Molecular Detector.

The AscencioDx COVID-19 test targets multiple locations on the viral genome, reducing the likelihood of missing a new strain. It also detects SARS-CoV-2 RNA in 20 minutes. It covers 99.99% of all omicron variants as well as prior variants of concern.

The AscencioDx Molecular Detector's proprietary, compact design uses reverse transcription loop-mediated isothermal amplification technology that is similar to more expensive and complex PCR testing. Unlike PCR testing, however, it neither requires sending samples to different locations nor waiting days for results.

According to Anavasi, both devices create less biowaste than other molecular point-of-care tests because the detector is reusable for at least 3,000 test cycles. Batteries and electronic components need not be thrown out after a single use. The AscencioDx system also has minimal packaging and fewer disposable components than other molecular point-of-care tests.

The Food and Drug Administration (FDA) recently issued an emergency use authorization (EUA) for the first over-the-counter at-home diagnostic test that can differentiate and detect influenza A and B and SARS-CoV-2.

The Lucira COVID-19 & Flu home test is a single-use kit that provides results in roughly 30 minutes. The test can be purchased without a prescription and performed completely at home using nasal swab samples self-collected by individuals ages 14 years or older or by an adult for individuals 2–14 years of age.

In individuals with symptoms, the Lucira COVID-19 & Flu home test correctly identifies 99.3% of negative and 90.1% of positive influenza A samples, 100% of negative and 88.3% of positive SARS-CoV-2 samples, and 99.9% of negative influenza B samples. Because of insufficient circulating influenza B cases to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens. The EUA requires Lucira to continue to collect samples to study the test's ability to detect influenza B in real-world settings.

In the wake of this authorization, FDA officials said that they recognize the benefits of home testing and that the agency will continue to use its authority to increase the number of accurate and easy-to-use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses.