Dive Brief:
- Abbott announced late Wednesday it received emergency use authorization from the FDA for its RealTime SARS-CoV-2 molecular test for the novel coronavirus.
- The company is immediately shipping 150,000 tests to existing customers and will scale up production to make 1 million tests per week by the end of this month. The test runs on Abbott's m2000 RealTime system, used in more than 175 U.S. labs and hospitals, with the ability to process up to 470 tests in 24 hours.
- EUAs were issued separately on Friday for both Roche and Thermo Fisher. Since then, FDA announced late Monday two more for Hologic and LabCorp and separately Wednesday for Quest and Quidel. FDA is trying to fast-track approvals to help commercial labs meet the increasing demand for testing. However, the American Clinical Laboratory Association sent a letter to Congress on Wednesday saying it is concerned that the federal government is "not recognizing the strain" on the industry to keep up.
Dive Insight:
Abbott joins six other companies receiving FDA's emergency use authorization within the last week as the Trump administration attempts to leverage the private sector, including commercial labs, to boost the nation's testing capacity.
In the days and weeks ahead, the administration says it is relying on high-throughput testing from these companies to increase the number of coronavirus tests performed by commercial labs nationwide such as LabCorp and Quest. "We've now moved into platforms that can run, basically, tens of thousands of tests per day," said Deborah Birx, White House coronavirus response coordinator, in a Wednesday press briefing.
Thermo Fisher is currently "pushing out most of their laboratory testing capacity" this week, according to Birx. At Tuesday's White House briefing, Birx appealed directly to Thermo Fisher to "not wait for orders" and to get its tests into the field immediately to meet growing demand for testing as the virus continues to spread throughout the U.S.
Thermo Fisher is seen by the administration as critical to boosting the nation's COVID-19 testing capacity, according to Birx, "because their platform is in 2,000 laboratories" across the country and "they're the ones that are putting out the million tests this week."
A spokesperson for Thermo Fisher confirmed to MedTech Dive the company is working with Lab Corp and Quest to ensure the broadest availability of testing and is currently "working to ship inventory on hand of 1.5 million" tests.
ACLA, which includes LabCorp and Quest, sent a letter on Wednesday to congressional leaders making the case for its members on the "frontlines" of the nation's response to the coronavirus outbreak, having performed 43,000 tests since Feb. 29, yet without assurances on how these testing services will be paid for.
"Clinical laboratories need additional support from Congress to ensure we have the necessary staffing, supplies and equipment to fulfill that vital promise," states ACLA's letter, which calls for the creation of a $5 billion Emergency Laboratory Surge Capacity Fund administered by the Department of Treasury.
ACLA proposes that the fund would be used to help support labs conducting COVID-19 tests by covering capital and supplies acquisition for testing platforms, reagents and swabs as well as costs for uncompensated coronavirus tests.
"Free testing for COVID-19 has now been promised to the American people. Laboratories should not bear the cost of 'free' testing," wrote ACLA's President Julie Khani, adding the "laboratory industry wholeheartedly supports no-cost testing but is in critical need of additional support from Congress."
