Critics Say New At-Home Test Is Expensive and Late to Market

They say the first over-the-counter test for COVID-19 to get EUA status from the FDA ‚Äúis a waste of money‚ÄĚ

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. ‚ÄúResults are delivered in as¬†little as 20 minutes via their smartphone,‚Ä̬†the FDA said.

Former FDA Commissioner Stephen¬†M. Hahn, MD, characterized the EUA as¬†a significant milestone. ‚ÄúBy authorizing a¬†[COVID-19] test for over-the-counter use,‚Ä̬†he said, ‚Äúthe 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.‚ÄĚ

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. ‚ÄúIn people without symptoms,¬†the test correctly identified 91% of positive¬†samples and 96% of negative samples.‚ÄĚ

Critics: ‚Äėa Waste of Money‚Äô

But some critics of the test called it a¬†‚Äúwaste of money,‚ÄĚ 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.



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