The Department of Health and Human Services announced Thursday that it has launched a pilot program with five states to introduce a rapid point-of-care facility Covid-19 Test with the same diagnosis that the National Basketball Association uses to end their season.
The pilot program, which was passed by Florida, Louisiana, New Jersey, Texas and Alaska, is expected to run up to 100,000 tests a day by the spring, according to federal treaty and HHS officials. The NBA relied on tests developed by California-based Cue Health to create an isolation zone at Walt Disney World near Orlando to protect their players and to cover the last eight games of the 2019-20 regular season and the 2020 playoffs break up.
Adm. Brett Giroir, assistant health secretary who leads the US government’s testing efforts, told CNBC the states were selected “because of their sizable Covid cases and great partnerships during the pandemic.”
Many epidemiologists and health specialists have urged the government to ramp up production of rapid tests to contain the coronavirus, which is causing new record cases every day. Widely used tests aim to identify infectious people at an early stage in order to cut chains of transmission and at the same time to help reopen businesses and schools.
The test by Cue, which is supported by Investors including Johnson & Johnsonis a molecular test that uses a sample taken from the lower part of the nose with a swab and gives results in about 20 minutes.
The test can be performed outside of a clinical laboratory because it is performed on a fully self-contained system, according to HHS, which avoids some of the bottlenecks and delays that plague other molecular PCR tests when the demand for test bursts increases. Tests that require laboratory analysis can take days, especially if the sample needs to be sent to a laboratory.
Cue developed the test in partnership with the Biomedical Advanced Research and Development Authority, which is part of HHS. The partnership began in 2018 when BARDA awarded Cue $ 14 million to develop a molecular influenza test with the option to extend the agreement to a total of $ 30 million over 60 months. At the beginning of the pandemic, BARDA expanded its partnership with Cue to develop a test for the coronavirus.
Last month, HHS and the Department of Defense did announced that they have placed a $ 481 million contract with Cue to speed up the production of the test. The deal stipulates that Cue will increase production to 100,000 a day by March. The US is purchasing 6 million tests and 30,000 monitoring systems that will be used to process the tests.
Giroir said the test “is very easy to use and reads automatically, eliminating the possibility of misinterpretation by the user.”
According to Cue, the test is among the most promising in development because it is more accurate than antigen tests, which sometimes need to be confirmed by a molecular test, and because it gives results faster than laboratory-based PCR tests.
“With Cue’s COVID-19 test, antigen test results verification can be done on-site in many cases,” Giroir said in a statement. “The pilot program will help us determine how well the cue test is being adapted in institutions and communities.”
HHS is currently sending millions of authorized antigen tests to states, nursing homes, and elsewhere. However, inaccurate results of the tests have led to this Confusion in some states. A point-of-care molecular test will help address misdiagnosis concerns, Ayub Khattak, founder and CEO of Cue Health, said in a phone interview.
“The key is the sensitivity of a laboratory test, but the usefulness of an antigen test,” said Khattak. “Being able to confirm in 20 minutes versus in two or three days is very helpful in making the right diagnosis earlier.”
Cue said the tests in the pilot program will be used to confirm positive antigen tests and retest “suspicious negatives” for people living in nursing homes, long-term care facilities, assisted living facilities, and veterans’ homes, among others. The Department of Defense will use the tests internally, Cue said.
Cue said it will provide training support to participating institutions. Khattak said that as more states join the program, the company will work with governors to deliver the tests to potentially diverse environments such as drive-through testing clinics, schools and meat packers.
Cue provides HHS with 27,000 tests for the first pilot program. However, Khattak hopes the program will expand to more states soon, adding that the company will run “hundreds of thousands” of tests in December.
The Food and Drug Administration approved the test in June “under the supervision of qualified medical personnel everywhere” Company said at the time. However, in a statement to CNBC, Giroir stated that approval for Cue’s test “includes testing asymptomatic individuals”.
Abbott LabThe ID NOW test, which is also a rapid molecular test, is “currently only for symptomatic people,” said Giroir. “The cue detection level seems to be better than ID NOW.”