The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have jointly awarded an $11.6 million contract to Puritan Medical Products Company to expand domestic production capacity of the nasal swabs used with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, according to a press release from HHS.
Awarded November 19, the new contract will allow Puritan Medical to expedite upgrades at its Maine facility and increase production capability of Cue’s nasal swabs to 3 million per month by March 2021. These efforts support the federal government’s procurement of 6 million Cue test kits – which include the Cue Sample Wand as well as Cue COVID-19 Test Cartridges – as part of a $481 million contract awarded to Cue on October 13 to increase production to 100,000 test kits per day by March 2021. During the week of November 9, HHS began a pilot distribution of the test kits, shipping 27,000 test kits to five states.
The test generates results in about 20 minutes at the point-of-care (POC).
The contract with Puritan Medical Products follows an earlier $51.51-million contract, which HHS and DOD awarded in July, to help fund a new production facility in Maine, increasing production capacity of flock-tip swabs to an additional 45 million swabs per month or more by March 2021. The expansion was funded by the CARES Act to meet demand for the swabs for testing both COVID-19 and the seasonal flu. Puritan Medical is the only U.S.-based manufacturer of flock tip swabs.
Funded by the Health Care Enhancement Act, the new contract was led by the Department of Defense Assisted Acquisition Cell in coordination with the HHS Office of the Assistant Secretary for Health to support domestic industrial base expansion for critical medical resources.
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 SARS-CoV-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 from BARDA, 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.
