Skip to main content
Premium Trial:

Request an Annual Quote

Responding to Coronavirus Test Shortage, FDA Lets NY State Health Department Authorize Assays

NEW YORK – Responding to a severe shortage of tests for the novel coronavirus in the state of New York, the US Food and Drug Administration on Thursday gave the New York State Department of Health permission to authorize New York laboratories to begin patient testing.

In a statement issued on Friday, the agency said it is "not objecting" to the NYSDOH's approach, under which labs need to provide validation data to the health department within 15 days of starting testing instead of having to pursue an Emergency Use Authorization with the FDA.

FDA said its decision was based on the fact that NYSDOH "has a long-established framework in place for [the] oversight of laboratory-developed tests in New York State" and that it has previously accredited the health department's Wadsworth Center in Albany as a third-party reviewer for certain molecular tests.

"This NYSDOH action shows the FDA's extreme flexibility and adaptability during times of public health emergencies," said FDA Commissioner Stephen Hahn in a statement, adding that New York labs "will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State."

New York's governor Andrew Cuomo said on Thursday that the state is partnering with 28 private labs over the next several weeks and that the first drive-through testing facility will open in New Rochelle on Friday. He also said that the state is contracting with Opko Health's BioReference Laboratories to provide testing for this and other locations. BioReference plans to offer 5,000 tests per day, which will become available next week.

The Scan

Guidelines for Ancient DNA Work

More than two dozen researchers have developed new ethical guidelines for conducting ancient DNA research, which they present in Nature.

And Cleared

A UK regulator has cleared former UK Prime Minister David Cameron in concerns he should have registered as a consultant-lobbyist for his work with Illumina, according to the Financial Times.

Suit Over Allegations

The Boston Globe reports that David Sabatini, who was placed on leave from MIT after allegations of sexual harassment, is suing his accuser, the Whitehead Institute, and the institute's director.

Nature Papers on Esophageal Cancer, Origin of Modern Horses, Exome Sequencing of UK Biobank Participants

In Nature this week: genetic and environmental influences of esophageal cancer, domestic horse origin traced to Western Eurasian steppes, and more.