Estimates Fall Short of F.D.A’s Pledge for 1 Million Coronavirus Tests

Public health experts have become concerned that the lack of adequate testing in several states has led to community transmission and warned there may be many undetected cases that could lead to further infections.

New York State’s public health lab, which was one of the first to receive emergency approval for its own testing, set a goal of conducting 1,000 tests a day statewide, according to a statement by Gov. Andrew M. Cuomo.

A handful of private companies have said they are working on a test for the virus, but none are yet available in the United States. Hologic said in a statement Monday that it expected to apply for approval on an emergency basis “in the coming weeks.”

Another company, Cepheid, has said it does not expect to get emergency approval from the F.D.A. for its test before April. Dr. David Persing, the company’s chief medical officer, said last week that the company still wanted to ensure its test was accurate. “We are moving aggressively,” he said.

On Monday, Darwa Peterson, a Cepheid spokeswoman, said the F.D.A. policy to allow more labs to conduct tests hadn’t changed the company’s timeline. “We still need to optimize and validate our tests because commercial vendors are held to a high standard,” she said.

Qiagen, another company working on testing, said Tuesday it expected F.D.A. approval later this month, but that it was still gathering data and testing its product, noting that “this does take some time.”

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

Dr. Hahn was not the only Trump administration official to promise radically expanded testing. Over the weekend, Vice President Mike Pence made similar claims, appearing on television to say that more than 15,000 test kits — which contain materials to test between 700 to 800 samples — were being shipped to labs.

Source Article