Recap: The 5 COVID-19 Related FDA Authorizations So Far in May 2020

Here is a look at 5 of the US Food and Drug Administration (FDA) authorizations in the month of May so far:

FDA Authorizes First CRIPSR Test Kit for COVID-19

The Sherlock Biosciences device, which provides results in approximately one hour, is the first authorized test to use CRISPR technology.

The new test kit is designed for laboratory use under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. The kit programs a CRISPR molecule to detect specific signature for SARS-CoV-2 by nasal, nasopharyngeal, or oropharyngeal swabs, or by bronchoalveolar lavage (BAL) specimen.

Once a signature is found, the CRISPR enzyme activates and releases a detectable signal for the tester. Sherlock Biosciences is currently developing a new platform that is instrument-free and handheld—similar to that of an at-home pregnancy test, according to the company.

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FDA Authorizes At-Home Sample Collection for COVID-19 Testing

The US FDA has authorized the first diagnostic test providing a home-collected saliva sample option for individuals with potential coronavirus 2019 (COVID-19).

The Emergency Use Authorization (EUA) was issued to Rutgers Clinical Genomics Laboratory for their laboratory developed test, the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. It is now permitted for at-home sample collection, after having received an EUA last month for sample collection at a laboratory.

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FDA Grants Emergency Use Authorization to Heart Biosensor for COVID-19 Patients

The US FDA has granted Emergency Use Authorization status to a wearable bionsensor for cardiac monitoring in coronavirus disease 2019 (COVID-19). The authorization was granted to VitalConnect.

The VitalPatch is now authorized to monitor patients for changes in QT interval. Investigational drugs being administered to COVID-19 patients, such as chloroquine and hydroxychloroquine, can cause prolongation of QT intervals and life threatening arrhythmias. SARS-CoV-2 infection also has been observed to have some effect on the heart.

The device is a disposable, band-aid sized wearable patch, each with a seven-day battery life.

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FDA Grants Emergency Use to Roche SARS-CoV-2 Antibody Test

The US FDA has granted Emergency Use Authorization (EUA) to a SARS-CoV-2 antibody test which reports a ≥99.8% specificity and 100% sensitivity at 14 days post-PCR confirmation.

The Elecys Anti-SARS-CoV-2 antibody test from Roche is designed to determine coronavirus 2019 (COVID-19) exposure, and whether the patient has developed antibodies against the virus.

The EUA led to the company’s statement that tens of millions of tests will be provided globally this month for countries accepting the CE mark, as well as the US. Developers hope the test’s functionality and availability is expanded as more is learned about the pathology and patient immunity to SARS-CoV-2.

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FDA Issues EUA for Remdesivir After Trio of Studies

The US FDA has issued an emergency use authorization of the antiviral drug remdesivir for the treatment of patients with coronavirus 2019 (COVID-19).

The decision comes just days after clinicians were hit with a wave of new information from an array of trials assessing the drug in patients with COVID-19. The results indicate mixed findings for benefit, but ended on an optimistic note.

The initial data released Wednesday were shared by Gilead, and were overall positive. Then the second results, from a study in Hubei, China, cast doubt on efficacy.

By the end of the day, however, remdesivir had the praise of National Institutes of Allergy and Infectious Diseases (NIAID) director Anthony Fauci, MD, who told reporters that preliminary results of another trial—overseen by NIAID—could make the antiviral a "standard of care," although the data still need to be properly peer reviewed.

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