The Linea 2.0 is a high-throughput multiplex RT-PCR assay that targets the E and N genes of SARS-CoV-2, while the Linea collection kit is a self-collection kit used for nasal swab specimens
Applied DNA Sciences is seeking an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Linea 2.0 Covid-19 assay and Linea unsupervised at-home sample collection kit.
The company, via its wholly-owned clinical laboratory subsidiary Applied DNA Clinical Labs (ADCL), has submitted a request to the regulator for both products to receive the status.
Upon receiving status for both products, ADCL’s safeCircle Covid-19 testing platform will be expanded to meet the requirements of enterprises.
The safeCircle, a fully integrated testing platform for enterprise and educational institutions, offers a range of Covid-19 diagnostic testing and associated services that consist of sample collection, test site infrastructure design and management, results tracking, and vaccination status management.
Applied DNA president and CEO Dr James Hayward said: “The unprecedented surge in Covid-19 cases driven by the Omicron variant, we believe, makes clear that the need for accurate and rapid PCR-based testing is more important than ever.
“We believe this EUA request positions us to service existing demand for enterprise-scale Covid-19 testing with a compelling selling proposition where remote work is not a scalable option and a dependence on less sensitive, antigen-based tests can potentially lead to outbreaks and interruptions in business continuity.”
Applied DNA has designed the Linea 2.0 high-throughput multiplex RT-PCR assay to target the E and N genes of SARS-CoV-2.
The variant agnostic assay holds the potential to identify all known SARS-CoV-2 variants. It is validated for single sample and robotic pooled testing.
Last December, the assay secured conditional approval from the New York State Department of Health.
The company has designed the Linea collection kit to facilitate the simple self-collection of nasal swab specimens without supervision by medical personnel.
Upon collection, individual samples can be shipped directly back to ADCL and results will be delivered between 24 hours and 48 hours, the company said.