Dive Brief:

• Computer vision-focused healthcare company Gauss Surgical on Monday announced its clinical study results for an at-home rapid COVID-19 test it contends is comparable to the polymerase chain reaction (PCR) gold standard for detecting SARS-CoV-2 infections used in CLIA-certified laboratories.
• The rapid coronavirus diagnostic demonstrated 94% positive agreement and 97% negative agreement compared to a PCR test, according to results of a 159-participant study. The company plans to submit an FDA application for an emergency use authorization that includes those results. If given the green light, it would be the first at-home rapid COVID-19 antigen test to receive an EUA enabling people to test themselves for active infection. 
• Gauss and biotech company Cellex in September announced their partnership to launch the diagnostic which uses a nasal swab for self-collection and an AI-powered smartphone app to deliver results within 15 minutes. Michael Mina, a professor of epidemiology at Harvard's T. H. Chan School of Public Health, said in a press briefing Friday that while FDA could soon issue an EUA for such a fully at-home test, it might not be "massively produced" initially in sufficient numbers needed for mass screening.  

Dive Insight:

Public health experts say allowing people to take a COVID-19 test at home and let them know within minutes whether they’re infected could be critical to reducing transmission of the virus. While FDA has granted EUAs for sample collection kits consumers can use and send to laboratories for testing, Gauss hopes its test could be the first to empower people to test themselves at home for active infection and, importantly, receive results at home within minutes.

The goal of the study, which included 159 participants that were both symptomatic and asymptomatic, was to evaluate the performance of the Gauss rapid at-home antigen test and smartphone app compared to an EUA-authorized PCR test for infection performed in a CLIA-certified laboratory.

The study included 36 participants who were COVID-19 positive by PCR and 123 participants who were negative by PCR. The Gauss rapid antigen test, which includes a test cassette from Cellex, showed 94% positive agreement and 97% negative agreement compared to PCR when using the computer vision app.

Users follow video instructions to collect a nasal swab sample and perform the self-administered test. Gauss' AI-powered app interprets the test with an iPhone or Android smartphone that analyzes a scanned image using a neural network algorithm to generate a final result. 

The company did not provide details beyond a press release on the results.

These types of COVID-19 tests "hold immense power" and can potentially be scaled to "incredible numbers," Mina said, though he warned that EUAs are "not exactly a high bar" and the first such at-home diagnostics won't be massively produced.  

"If we just deploy that out to random people's homes, it's going to do almost nothing," he added. "We need to identify places that are being hit the hardest and try to understand if these tests can really be used to stop spread."

Mina contends there's been no effort to date from FDA and CDC to provide "serious guidance" about how these kinds of tests could be deployed and used by consumers. "I worry that we are going to have a haphazard rollout of them," he said.