FDA Approves Rapid Coronavirus Test; New York State to Conduct Trial on Drug Combo

March 21, 2020

The number of cases of COVID-19 nationwide moved past the 20,000 mark, of which more than half are in New York state, a fact that Gov. Andrew Cuomo said was a function of the state testing more people.

The FDA has approved the first point-of-care test for coronavirus that can get results in 45 minutes, and New York state will conduct a trial of the drug combination that could be used to treat the novel coronavirus COVID-19.

The number of cases of COVID-19 nationwide moved past the 20,000 mark, of which more than half are in New York state, a fact that Gov. Andrew Cuomo said was a function of the state testing more people.

Cuomo made his remarks at a lengthy press conference where he announced that the state is receiving 10,000 doses of the drug combination hydroxychloroquine and Zithromax from FDA, which will be used in a clinical trial. Earlier in the week, the Democratic governor said he would call for New York to be “first in line” for the trial.

The governor also said he is lifting the state’s “no work” order for Regeneron, so the biotech can evaluate whether sarilumab (Kevzara), which is used to treat rheumatoid arthritis, can be used to treat COVID-19. Cuomo said he was exempting Regeneron, based north of New York City, “because they could possibly have a significant achievement for us.”

FDA’s action was first reported in the Washington Post. Emergency authorization was granted to Cepheid for its Xpert Xpress SARS-CoV-2 test, acording a statement from the agency; the company also posted a video on its website for laboratory officials, providers, and health systems. The agency has taken a string of steps in the past week to make more tests for available to diagnose COVID-19, including clearing tests for emergency use and allowing state health departments to clear tests.

A company official from Cepheid told STAT News that reading the test requires one of the company's machines, and it would be most useful to diagnose a patient in the emergency department or a healthcare worker with symptoms. Thus, it may not be the solution to widespread testing shortages.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar in a statement.

New York tests more people. In November 2017, New York State’s Department of Health gained authority to approve diagnostic tests as part of an application to approve a tumor profiling assay developed by Memorial Sloan Kettering Cancer Center. That change put the state ahead of others on the testing front as COVID-19 hit.

Cuomo presented data to show the state had performed more than 45,000 tests, while California and Washington State were the next closest with about 23,000 tests each. He said this fact, combined with the high population density of New York City, accounted for the high number of diagnosed cases in his state.

“The more tests you take, the more positives you will find,” he said.

Cuomo also described efforts to enlist the fashion industry and manufacturers to provide the masks and supplies that hospitals lack. He said he will ask the federal government to send 4 military field hospitals to serve up to 1000 patients, and said he was scouting sites that could include the Jacob Javits Center in Manhattan.

Equipment shortages prompted a joint letter signed by the American Medical Association, the Medical Group Management Association, and other physician groups that called on Congress to include financial support for acquiring personal protective equipment (PPE) in the COVID-19 stimulus package. The letter also called for:

  • Requiring all payers to provide coverage and payment for audio-only telehealth visits with patients, at the same level as in-person visits;
  • Providing financial support to physicians and practices that are diagnosing and treating patients at risk of COVID-19.
  • Providing dedicated financial support to physicians and practices experiencing economic losses due to suspending elective visits and procedures.