FDA Moves to Boost Coronavirus Testing Capacity by Giving States More Power
The Food and Drug Administration (FDA) is giving states the ability to authorize laboratories to develop their own diagnostic tests for COVID-19, as it did recently for the New York State Department of Health. The labs will not have to obtain Emergency Use Authorization from the agency. FDA also said in certain situations it will not object to any manufacturers that distribute newly developed tests before the FDA grants emergency clearance, and a similar policy will apply for labs that use these new tests. In addition, FDA approved new tests to be distributed by LabCorp and Hologic, and it is issuing new recommendations for companies that want to develop blood tests for measuring antibodies. FDA Commissioner Stephen Hahn, MD, says: "The policy is intended to achieve a balance between providing regulatory flexibility while allowing for scientific rigor. We believe this will [create] a surge to meet the demand we expect to see, although it is somewhat difficult to quantify" the number of tests that will become available. Former FDA Commissioner Scott Gottlieb, MD, estimates that the United States currently has capacity to run 175,000 tests a week, according to data from the American Enterprise Institute.
FDA Allows Emergency Use of Lab-Developed Coronavirus Tests in New York
The Food and Drug Administration (FDA) announced that the New York State Department of Health can authorize certain laboratories to begin testing for COVID-19. FDA granted this capacity in response to the urgent public health need for additional testing. The expansion of testing is crucial to evaluating the extent of the U.S. outbreak and identifying where it is spreading. New York City Mayor Bill de Blasio said the city might implement its own automated, high-volume tests without federal authorization.
As Coronavirus Testing Increases, Some Labs Fear a Shortage of Other Supplies
New York Times
Across the globe, laboratories are concerned about possible shortages of materials and chemicals needed to run tests for the novel coronavirus. Cases of COVID-19 have spread to more than two-thirds of U.S. states. Some lab executives say they already have low supplies of substances needed to extract RNA from nasal swabs as well as reagents used in the tests themselves. Lab executives are considering whether to secure materials from other research labs that are not involved in making or operating coronavirus tests. Several labs say they have had difficulty obtaining virus samples used to validate the tests. At the University of California, Los Angeles, the chief of the microbiology section of the medical center's clinical lab was so concerned about his supply of RNA extraction kits that he sent an email to colleagues at the university's research labs asking if they had any. Eric Blank, chief program officer at the Association of Public Health Laboratories, says his organization has been hearing about back orders of the extraction kits and other supplies. Blanks says, "It just depends on how rapidly the manufacturers of some of these other ancillary materials needed to run the tests can ramp up their production." Meanwhile, the Centers for Disease Control and Prevention revised its guidelines to allow for the collection of one specimen swab rather than two, a move that the American Society for Microbiologists says would reduce the amount of necessary testing reagents by half.