Source : 'HBW Insight'
The US Food and Drug Administration granted its first emergency use authorization for an OTC at-home molecular diagnostic test to Cue Health Inc. after investing $481m in the San Diego firm in 2020.
On 5 March, the FDA said it gave marketing authorization to Cue Health’s at-home molecular nucleic acid amplification test (NAAT) capable of detecting genetic material from the SARS-CoV-2 virus. The COVID-19 test is available nonprescription and has been authorized for self-use by adults as well as children 2 and older when assisted by an adult.
The FDA says it expects Cue Health to produce more than 100,000 tests per day by this summer.
The test components include Cue's single-use COVID-19 test cartridge and sample wand nasal swab, its cartridge reader and its mobile app to be installed on a smartphone or other digital device. Users must create an account on the app that will track their results to allow public health authorities to monitor disease prevalence.
The reusable battery-operated Cue cartridge reader runs the test cartridge after the user has inserted the sample wand with the user’s nasal material and transmits the results to the health app in about 20 minutes.
According to reviewers, the test correctly identified 96% of positive samples from individuals known to have symptoms and 100% of positive samples from subjects symptoms.
The EUA approval follows the departments of Health and Human Services and Defense (DoD) in October investing in Cue Health to produce 6m point-of-care molecular COVID-19 tests and have those ready to distribute by this month. At the time, federal officials said the investment would help the company keep its supply chain in the US and rapidly increase its production capacity, which was being used to supply the tests to health care, educational and institutional settings. ()
"Cue's tests provide results in about 20 minutes with the kind of accuracy provided by lab tests that can take several days, adding to our dramatically expanding supply of rapid tests that can support safe reopening,” Alex Azar, former HHS secretary said in October.
To date, the FDA says it has authorized more than 330 COVID-19 tests and collection kits for a variety of uses, users and locations to provide a wide array of test options. The agency has also prioritized reviewing and authorizing products to fight the coronavirus pandemic based on a number of factors, including accessibility to the public and speed with which patients are able to see results.
The agency previously granted home-use EUAs for COVID-19 antibody and antigen tests, but Cue's is the first for a molecular test, considered the most accurate kind of diagnostic for COVID-19. ()
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic. Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public,” said Jeff Shuren, director of the agency's Center for Devices and Radiological Health, in a statement.
This article previous was published by Informa Pharma's Medtech Insight newsletter.
By Ferdous Al-Faruque