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FDA issues emergency use authorization for Yale's saliva coronavirus test

A health worker practitioner administers a coronavirus test in Brockton, Massachusetts, on Aug. 13. Photo: David L. Ryan/The Boston Globe via Getty Images

The Food and Drug Administration issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test on Saturday.

Why it matters: The test uses a new method of rapidly processing saliva samples when testing for the virus and "is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett Giroir.

How it works: The test, deemed less expensive and less invasive than traditional methods, does not require specific swabs or collection devices to gather samples. Instead, a patient's saliva can be collected in any sterile container, which could cut down on the use of medical supplies the FDA says are in shortage.

  • Samples are also collected under the observation of a health care professional, meaning the method could also lower the risk posed to workers who handle samples.

What they're saying: "Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country," the FDA said.

The big picture: This is the fifth test the FDA has allowed that uses saliva as a sample for testing.

  • SalivaDirect is being further validated as a test for asymptomatic people through a program that tests players and staff from the NBA, YaleNews writes.

Go deeper

Maria Arias
Nov 22, 2020 - Politics & Policy

Operation Warp Speed leader: COVID vaccine push is "isolated from a political environment"

Moncef Slaoui in the Rose Garden on Nov. 13. Photo: Mandel Ngan/AFP via Getty Images

Moncef Slaoui, the White House's top scientific adviser to Operation Warp Speed, told Chuck Todd on "Meet the Press" on Sunday that the Trump administration's efforts to accelerate the development of a coronavirus vaccine is "isolated from a political environment" and that a change in administration "doesn't, frankly, make a difference" on its efficacy.

Why it matters: Slaoui told ABC's George Stephanopoulos on Sunday that he has not yet had contact with Joe Biden's transition team, as the president-elect prepares to inherit one of the country's biggest crises ahead of an expected vaccine distribution effort that would require massive logistical cooperation between states and the federal government.

Go deeper (1 min. read)Arrow
Maria Arias
Nov 22, 2020 - Economy & Business

In photos: Americans wait at food banks before Thanksgiving

Residents line up in their cars at a food distribution site in Clermont, Fla., Nov. 21. Photo: Paul Hennessy/SOPA Images/LightRocket via Getty Images

Thousands of Americans waited in long lines at food banks in the week before Thanksgiving to pick up turkeys, canned goods, broccoli and other vegetables.

Why it matters: As the holiday season approaches, families across the U.S. are in need of food assistance due to chronic unemployment and economic hardship caused by COVID-19 — and many food pantries already served an unprecedented number of people this spring.

Go deeper (<1 min. read)Arrow
Rebecca Falconer
Updated Nov 23, 2020 - World

Oxford University says its coronavirus vaccine is up to 90% effective

A scientist working during at the Oxford Vaccine Group's laboratory facility at the Churchill Hospital in Oxford, England, in June. Photo: Steve Parsons/Pool/AFP via Getty Images

The University of Oxford announced Monday that a COVID-19 vaccine it's developed with AstraZeneca is 70.4% effective in preventing people from developing symptoms, per interim data from Phase 3 trials.

Why it matters: The Oxford-AstraZeneca vaccine is shown to work in different age groups and can be stored at fridge temperature. It is much cheaper than other vaccines in development and is part of the global COVAX initiative, designed to ensure doses go where they're most needed.

Go deeper (1 min. read)Arrow