The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes.

This is the third SARS-CoV-2 antigen test to secure an EUA, enabling it to be marketed without official FDA clearance for the duration of the pandemic. The other two are the Sofia SARS Antigen FIA by Quidel Corp. and the BD Veritor System for Rapid Detection of SARS-CoV-2 by Becton Dickinson. Like Lumiradx, the BD test is authorized for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs. Quidel’s test may be used with either nasal or nasopharyngeal swabs.

In clinical trials, the Lumiradx SARS-CoV-2 antigen test achieved 97.6% positive agreement vs. polymerase chain reaction (PCR) tests in patients who got the test within 12 days of first experiencing symptoms.

Shipments to start this month

“Actionable diagnostic results at the point of care lead to better health outcomes,” said Ron Zwanziger, Lumiradx’s CEO. “Now that the FDA EUA has been received, we are working with health systems, major retail clinics and employers to get our platform to health care providers quickly to utilize in their testing programs.”

The London-based company plans to begin shipping the tests to U.S. customers by the end of the month, with a goal of producing 2 million tests in September and ramping up capacity to 10 million tests in December.

The SARS-CoV-2 antigen test runs on the CE-marked Lumiradx point-of-care platform, which launched in the U.K. and Europe last year to test INR (International Normalized Ratio) for management of patients receiving anticoagulation therapy, a Lumiradx spokesperson told BioWorld. The platform includes a small, portable instrument, microfluidic test strip, standardized workflow and secure digital connectivity to the cloud and hospital IT networks.

“The SARS-CoV-2 antigen test is the only test currently available in the U.S. [on the platform], but Lumiradx plans to file for an EUA with the FDA for its SARS-CoV-2 antibody test shortly,” the spokesperson said.

Plans to further expand the platform’s offerings include a pipeline of more than 30 assays addressing various cardiovascular, infectious disease, diabetes and coagulation disorders, as well as different sample types that will operate on a single platform and workflow.

‘Positive news’ for antigen market

In a Thursday research note, William Blair analyst Brian Weinstein called the Lumiradx EUA “positive news for the antigen market given performance of the assay and its ability to help fill some of the ‘unfathomable’ demand that exists for antigen test.”

He said he anticipates additional announcements of COVID-19 antigen tests in the coming weeks and months, “including a less accurate non-instrumented test,” and predicted they will not yet be on a par with the at-home pregnancy tests people are wishing to see.

“We believe the most likely next approval, and the one with enough scale and access to critical testing components and infrastructure to make an immediate impact, would come from Abbott [Laboratories],” he wrote.

Abbott has acknowledged it’s developing an antigen test, but has declined to offer a timeline. The company’s version is expected to be a reliable, inexpensive test that does not require instrumentation.

Celltrion Group, of Incheon, South Korea, recently reported plans to launch two rapid COVID-19 testing kits, Sampinute COVID-19 Antigen Mia for detection of SARS-CoV-2 antigen and Diatrust COVID-19 IgG/IgM Rapid Test for detection of antibodies to SARS-CoV-2 in South Korea in the second half of 2020. The company is seeking the FDA’s EUA for both kits, with an application for the antibody test filed July 8 and the antigen test on July 24.

CDC guidance

Last week, the CDC issued interim guidance for rapid antigen testing for SARS-CoV-2 to support its use in different testing situations. The guidance noted it may be necessary to confirm a rapid antigen test result with a nucleic acid test, especially if the result is inconsistent with the clinical context, and said when confirming an antigen test with RT-PCR, the time lapse between the two samples should be less than two days and there should be no opportunities for new exposure between the two tests.

In late July, the FDA posted a template for applications for COVID-19 tests that can be performed entirely at home, in schools or at the office. The template addresses molecular and antigen diagnostic testing using specimens drawn from respiratory samples and saliva, and specifies the minimum number of subjects in human usability studies for over-the-counter and prescription-only tests.