Media Coverage

Lab operators Quest Diagnostics Inc and OPKO Health Inc said on Thursday they would be able to begin testing for coronavirus from next week, as the U.S. government ramps up efforts to increase diagnostic capabilities.

Despite intense scrutiny and criticism of the diagnostic testing rollout in the US for the SARS-CoV-2 virus, the emergency regulatory process may actually be proceeding at a much more rapid pace than past emergencies, which did not involve newly-emerged pathogens.[CR-LF][CR-LF]Commercial tests in development to date have faced bottlenecks in test validation, but the logjam now appears to be clearing with new US Food and Drug Administration feedback and the availability of control materials.

After a weekslong delay, thousands of coronavirus test kits are headed to state and local laboratories, Vice President Mike Pence said Wednesday.[CR-LF][CR-LF]But questions remain about when, exactly, those promised test kits will arrive and how well they will work.

The Trump administration met with private lab test developers on Wednesday to discuss increasing the availability of tests for the coronavirus and said that the companies had formed a consortium. Vice President Mike Pence said the U.S. Department of Health and Human Services has included coronavirus testing as an essential health benefit for health plans in a bid to increase Americans’ access to tests.[CR-LF][CR-LF]“We want every American to have access to testing,” Pence said.

Thanks, Mr. Vice President. I appreciate the opportunity and your leadership on this matter. We understand this a public health issue that we all have a role in, and we’re deeply committed to working through this together.[CR-LF][CR-LF]We also appreciate the support of the FDA and the Centers for Disease Control. They’ve been very good partners in this regard. And particularly over the weekend — the decision that was made to give us — a decision that accelerated our path to bringing tests to the market place. As Adam said, we’re validating it as we speak. And, hopefully, by the next week, we’ll able to ramp that up at a number of our laboratories throughout this country.