FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk

Dive Brief:

FDA has revoked the emergency use authorization for Curative's COVID-19 test, at the request of the company, six months after the agency issued an alert about the risk of false results.
The EUA was granted to the Curative test in April 2020, making it one of the first COVID-19 kits cleared for use with saliva samples. However, by January 2021, FDA had concerns about false results potentially linked to sample collection.
FDA said in a Thursday update to its safety communication on the test that the revocation, effective July 15, was requested by Curative "because the company is now using different EUA-authorized tests for the testing offered at its laboratories." Curative is using its labs to process other tests, namely the Abbott Alinity m SARS-CoV-2 Assay and a CLIA-validated test based on the CDC SARS-CoV-2 multiplex assay.

Dive Insight:

The introduction of the Curative test, which was brought to market in collaboration with KorvaLabs, was hailed as a win in the effort to scale up U.S. diagnostic capacity after a slow start early in the pandemic. Curative designed the test for use with swabs or oral fluid specimens. With swabs in short supply early in the crisis, the saliva option removed one bottleneck to testing.

Curative was reportedly processing 150,000 COVID-19 saliva samples a day by January 2021, less than one year after it was founded as a sepsis startup. The company's pivot to COVID-19 helped Los Angeles and other U.S. cities including Seattle scale up their testing capacity.

However, the test at the heart of the operation is now off the market. At the request of Curative, FDA revoked the EUA on Thursday.

"The test that is the subject of this safety communication is no longer being offered and is no longer authorized for emergency use by the FDA," the agency said in Thursday's announcement.

The FDA notice comes one month after Curative disclosed a partnership with Abbott. The agreement positioned Curative to offer the Alinity m SARS-CoV-2 Assay from early July. Curative also secured access to Abbott's Alinity m Resp-4-Plex, equipping it to test for SARS-CoV-2, Flu A, Flu B, and RSV in one kit.

In a statement, Curative said it will use the Alinity m SARS-CoV-2 Assay to detect the coronavirus in nasal swabs self-collected at a healthcare location. Curative also used a CLIA-validated test based on the CDC SARS-CoV-2 multiplex assay to test for the virus in upper or lower respiratory specimens. The portfolio of kits equips Curative to test asymptomatic and symptomatic people and run pooled tests.

The Abbott deal also positions Curative to test for multiple respiratory pathogens that can manifest in similar symptoms but need treating differently. The feared simultaneous waves of SARS-CoV-2 and influenza never materialized last winter but there are concerns for this season and there is already evidence of rising cases of respiratory syncytial virus.

Curative said that it made the decision to discontinue its PCR COVID-19 test and asked the FDA to revoke the EUA "as it is no longer needed" with a suite of new testing offerings for patients at its 15,000 sites in more than 20 states.