ONCE AGAIN, THE COMBINATION of the pandemic and the federal government may be creating a credible new competitor in the in vitro diagnostics (IVD) industry. This time, the lucky company is Ellume, which was just awarded $231.8 million from the Biden administration to scale up production of a home test for SARS-CoV-2.
Ellume was given an emergency-use authorization (EUA) from the federal Food and Drug Administration (FDA) in December. This allows the Australian company to market its over-the-counter COVID-19 at-home test to patients. The test will cost $30 and be available online, in pharmacies, and in other retail stores. Onebig advantage of this test is that it will not require a physician’s order, the FDA said in a press release announcing the EUA.
On Dec. 15, the FDA said the Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual age two or older. The at-home test uses an analyzer that connects with a smartphone app.
The app helps the user perform the test and interpret results. “Results are delivered in as little as 20 minutes via their smartphone,” the FDA said.
Former FDA Commissioner Stephen M. Hahn, MD, characterized the EUA as a significant milestone. “By authorizing a [COVID-19] test for over-the-counter use,” he said, “the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes.”
The test uses a mid-turbinate nasal swab, the FDA said, explaining that the sample is collected further back than a usual nasal swab, but not as far back as nasopharyngeal swabs. The test correctly identified 96%of positive samples and 100% of negative samples in individuals with symptoms, the FDA added. “In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.”
Critics: ‘a Waste of Money’
But some critics of the test called it a “waste of money,” according to STAT News. Last week, the Biden administration said it would spend $231.8 million to increase production of the Ellume test and produce 8.5 million versions of the test. The administration also said it would provide funding to build a factory in the U.S. that will eventually make millions of tests every month.
But critics said building a factory to boost production will take time when more Americans need access to COVID tests right away, STAT reported. Critics also said the test is needed now and at $30 is too expensive and complicated, STAT reported without naming those critics.
Nevertheless, Ellume has a quarter billion dollars of American taxpayer money to scale-up production of the SARS-CoV-2 tests. Post-pandemic, this manufacturing capacity can be devoted to other lab tests and make Ellume a serious competitor to existing IVD companies.