14 May 2020 - - The US Food and Drug Administration has provided Emergency Use Authorization for the clinical use of US-based Applied DNA Sciences Inc's (NASDAQ: APDN) patent-pending Linea COVID-19 RT-PCR test for COVID-19, the company said.

Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments to perform hi complexity tests.

CLIA labs can immediately begin ordering and using the Linea COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19.

The Linea COVID-19 assay kit is an rRT-PCR (reverse transcription, Real Time Polymerase Chain Reaction)-based assay designed to detect specific highly conserved target sequences of the SARS-CoV-2 Spike (S) gene.

The Linea COVID-19 assay is an advanced single-well multiplex test that allows for simple set up and higher-throughput as compared to tests that require multiple wells per test.

The Linea COVID-19 assay is approved to run on the FDA-approved Applied Biosystems QuantStudio Dx real-time PCR instrument, which allows for testing results for up to 94 samples within one hour, or more than 2,000 tests in 24 hours per device.

The company notes that while the Linea COVID-19 assay kit has been approved by FDA under an EUA for clinical use in CLIA certified labs for the detection of SARS-CoV-2 RNA, the Linea COVID-19 assay kit has not been FDA cleared or approved.

However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the US Department of Health and Human Services declares a public health emergency.

HHS secretary Alex Azar declared an emergency for COVID-19 on January 31, 2020.

The Linea COVID-19 assay kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Act, 21 USC. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

The Linea COVID-19 assay kit has been authorized only for the detection of nucleic acids from SARS-CoV-2, not for any other virus or pathogen.

In addition, the use of the Linea COVID-19 assay kit is indicated for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens including nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal swabs and oropharyngeal swabs, nasopharyngeal wash/aspirate or nasal aspirates collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.

The Linea COVID-19 assay kit has been authorized only for the detection of nucleic acids from SARS-CoV-2, not for any other virus or pathogen.

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.