In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.

The authorization follows by roughly a month the agency’s EUA for a prescription test for at-home use, the Lucira all-in-one test kit, which provides a 30-minute turn-around. The Lucira test can be administered to those aged younger than 14 only by a health care professional. The agency also granted an EUA to Labcorp, of Burlington, N.C., for the company’s Pixel home collection kit for direct sales to consumers. Sales are limited to those who have reached the age of 18, but the OTC collection kit must be sent to a Labcorp facility for processing. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said recently that the agency was prioritizing home testing systems, among other considerations.

Performance still second to PCR

The FDA said it has authorized more than 255 diagnostic tests since the start of the pandemic, a list that includes 25-plus tests that can be used on samples collected in the consumer’s home. The Ellume test is the first test that can be used entirely at home without a prescription, although the agency advised that the sensitivity and specificity of the Ellume test do not match the performance of molecular tests performed with polymerase chain reaction testing systems.

Studies of the Ellume demonstrated a sensitivity of 96% and specificity of 100% of in symptomatic individuals, while performance in asymptomatic individuals was 91% sensitivity and 96% specificity. The test is used with an app downloaded to a smartphone, which provides instructions for use and “reports the results as appropriate to public health authorities,” the FDA said. The test is designed to detect the SARS-CoV-2 virus from mid-turbinate nasal swabs drawn from any individual aged at least 2 years. The FDA said Ellume predicts it will produce more than 3 million of the tests in January 2021.

The U.S. NIH also made note of the development with a Dec. 15 press release stating that Ellume had received $30 million in U.S. taxpayer support for the test as part of the Rapid Acceleration of Diagnostics (RADx) program. Ellume USA LLC, of Valencia, Calif., is the U.S. agent for Ellume, which designed the test around a mid-turbinate nasal swab. The company indicated it will price the test at roughly $30 for institutions such as schools, health care facilities, and “employers.” In contrast, the Lucira test was expected to sell for $50 each. The projection for shipments of the Elllume test to the U.S. cited in the NIH press release is “millions of tests per month.”

At the time of the award under the RADx program, Ellume was developing two distinct test cartridges each of which was built around a single-use, digital fluorescent immunoassay antigen test characterized as capable of returning results in 15 minutes or less. One of the cartridges was designed for use by health care professionals at the point of care or in a lab setting when higher throughput is desirable.

Ellume explained the underlying technology as consisting of ultra-sensitive optics and proprietary software combined with multi-quantum dot fluorescence technology. The company is projecting shipment of at least 100,000 tests per day to the U.S., for a total of 20 million in the first half of 2021. The company received financial support from the Australian government as well, and solicited the support of Bosch Australia Manufacturing Solutions to expand capacity at the East Brisbane plant.

The EUA was based on a simulated home-setting clinical study of nearly 200 subjects aged 2 to 82 years. Enrollment in the study spanned five U.S. states, including Texas and California, and the results of the study were confirmed by scientists at Emory University in Atlanta.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, said the Ellume test is “a genuine breakthrough in COVID-19 testing.” Alexander said the feat is “the result of the extraordinary efforts of the National Institutes of Health’s ‘Shark Tank,’ or RADx initiative, which has produced 22 new ways to create tens of millions of diagnostic tests in the last eight months.”

Alexander noted that he and Sen. Roy Blunt (R-Mo.), who chairs the Senate appropriations subcommittee for the NIH, led the Senate effort in April to pass funding for the RADx program to ensure that the program would be able to leverage the resources of the Biomedical Advanced Research and Development Authority (BARDA) and the private sector “to fast track new technologies designed to produce tens of millions of tests.”

The news did not put a damper on other diagnostics companies looking to find leverage in the COVID-19 market. Axim Biotechnologies Inc., of San Diego, announced Dec. 15 that it has filed an amended emergency use application with the FDA for its lateral flow assay, which relies on serum, plasma or whole blood to determine the presence of neutralizing antibodies. Axim said the test can turn around results in less than 10 minutes, and indicated that the intent of the test is to confirm the durability of vaccine-induced immunity. This function would assist patients and health care professionals in determining whether a second vaccination is needed for vaccines that require more than one dose.