November 19, 2020
HHS Launches Pilot Program of Fast Molecular POC Test for COVID-19
The U.S. Department of Health and Human Services (HHS) has launched a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.
Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.
During the week of November 9, HHS distributed 27,000 test kits, which include the Cue Sample Wand (nasal swabs) and the Cue COVID-19 Test Cartridges, and 600 Cue Health Monitoring Systems (Cartridge Readers) as follows: 4,500 test kits and 100 cartridge readers each to Florida, Louisiana, New Jersey, and Texas, and 9,000 test kits and 200 cartridge readers to Alaska. Alaska received a greater quantity of components due to the remote nature of access to testing. The tests will also be used internally at the Department of Defense (DOD).
“The Cue Health testing system will undoubtedly be a valuable addition to our testing ecosystem,” said HHS Assistant Secretary for Health ADM Brett Giroir, M.D. “Having a highly specific and sensitive POC molecular test could dramatically improve infection control at nursing homes and other institutional settings especially.”
Currently, HHS sends millions of point-of-care rapid antigen tests that have emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to states, nursing homes, and others. These antigen tests, which detect specific proteins from the SARS CoV-2 virus, are inexpensive (free from the federal government) and provide same-day results – often within minutes.
Antigen tests are critical for quickly identifying people who are infected. They are used in nursing homes and other congregate care settings in which staff must be tested frequently for infection control. Although they are highly accurate, antigen tests can have false positives. In some cases -- for example, when an antigen test gives a positive result for a person in a low incidence area who does not have symptoms or known exposure – the results are verified by a molecular test.
Similarly, a person with a negative result where there is a high incidence of infection, might have a follow-up molecular test to confirm the results. The laboratory-based molecular tests – which HHS has also provided to states – may take two to three days; therefore, the person tested would be required to isolate until the results are confirmed or, in the case of a false negative, risk infecting patients, colleagues, family members, or others.
“Our strategy continues to be to get the right test to the right person at the right time,” Giroir added. “We recommend that nursing homes and other institutions follow a layered approach to testing – using rapid, inexpensive, and frequent point-of-care tests for screening staff and verifying the results with more sophisticated molecular tests when the situation warrants.”
“With Cue’s COVID-19 Test, verifying the antigen test results can be done on the spot in many cases,” he added. “The pilot program will help us determine how well the Cue test will be adapted in institutions and communities.”
The pilot program is part of a $481 million contract with Cue Health, Inc., awarded October 13 by HHS in collaboration with the Department of Defense (DoD). The public-private partnership enables Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021. The contract includes delivery of 6 million COVID-19 tests and 30,000 cartridge readers to the U.S. government to support the domestic COVID-19 response.
The Cue COVID-19 Test detects the virus’s ribonucleic acid (RNA), or genetic material. A trained health professional takes a sample from the lower part of the nose using the Cue Sample Wand nasal swab. The swab is then inserted into the Cue COVID-19 Test Cartridge, which is coupled to the Cue Health Monitoring System (Cue Cartridge Reader). After the cartridge reader analyzes the specimen, the device transmits the results to the Cue Health App on a connected mobile smart device.
The Cue COVID-19 Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on June 10, 2020. The test is performed by a health professional under the supervision of an authorized laboratory operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens, and only for the duration of emergency use declaration.
The Cue Health platform was developed and validated with funding awarded by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), starting in 2018 for the development of a molecular influenza test, with the option to expand the effort to include coronaviruses on March 31, 2020, BARDA announced its $13.6 million collaboration with Cue to accelerate the development, validation and manufacturing of Cue’s COVID-19 test.
This effort is being led by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in coordination with the DOD Joint Acquisition Task Force (JATF) and funded through the HHS Office of the Assistant Secretary for Health to enable and support domestic production of critical medical resources.