The ID Pipeline: FDA Activity From the Week of April 12, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 12, 2020.

Oral Fluid COVID-19 Test Receives FDA Authorization

Curative Inc, a coronavirus disease 2019 (COVID-19) testing startup, has announced that the FDA is granting its oral fluid test authorization under Emergency Use Authorization guidelines.

Los Angeles health care workers have been using the technology since March 21, and the emergency authorization expands permissions to health care workers nationwide.

Curative is currently processing about 5000 test results per day and producing 20,000 diagnostic kits per day. The tests have turnaround time of approximately 31 hours.

Read the full press release.

FDA Grants Emergency Use Authorization for 2 New COVID Antibody Tests

The US Food and Drug Administration (FDA) on Wednesday granted Emergency Use Authorization (EUA) for 2 new tests that can detect antibodies to SARS-CoV-2 (COVID-19), while Abbott Laboratories announced the launch of its own serology test.

The approvals were granted to Chembio Diagnostic Systems for its DPP COVID-19 System, and to Ortho Clinical Diagnostics for its VITROS^® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. These 2 tools join Cellex's antibody test, which was approved via EUA earlier this month.

Although there is some debate over the timeline of antibody detection, the FDA determined that the benefits outweigh the risks of potential false positives or negatives.

Read the full article.

FDA Grants Emergency Authorization to First COVID-19 Saliva Test

The US Food and Drug Administration (FDA) has granted emergency use authorization to a saliva-based test for SARS-CoV-2 infection. The device was developed by Rutgers University’s RUCDR Infinite Biologics laboratory.

This is the first diagnostic for SARS-CoV-2 infection which uses a saliva-based collection method to be granted authorization by the FDA.

The new method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs, may allow for broader testing rollout than the current methods of nasal and throat swabs.

Read the full article.

FDA Issues Additional Emergency Use Authorization for N95 Decontamination

The US Food and Drug Administration (FDA) has issued an emergency use authorization to Advanced Sterilization Products (ASP). This authorization could replenish the supply of 4 million N95 masks per day.

This authorization was granted shortly after an authorization was granted that will support the decontamination of 750,00 masks each day.

Read the full article.