The EUA amendment extends the RT-PCR platform authorization from Applied Biosystems’ (ThermoFisher Scientific) QuantStudio Dx and QuantStudio 5 Real-Time PCR systems to include Applied Biosystems 7500 Fast Dx Real-Time PCR System (ABI 7500).
Applied DNA significantly expands addressable market for Linea Covid-19 assay kit via successful mmendment to FDA EUA. (Credit: Daniel Roberts from Pixabay)
Applied DNA Sciences, a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that expands the installed base of RT-PCR platforms that can process the Company’s Linea™ COVID-19 Assay Kit.
The EUA amendment extends the RT-PCR platform authorization from Applied Biosystems’ (ThermoFisher Scientific) QuantStudio™ Dx and QuantStudio™ 5 Real-Time PCR systems to include Applied Biosystems™ 7500 Fast Dx Real-Time PCR System (ABI 7500). The ABI 7500 has the capacity to perform 400 – 800 tests in 24 hours and is found in the majority of clinical laboratories nationally.
“With this amendment to our EUA, we significantly increase the number of authorized devices on which our assay kit can run and remove a gating factor to the more widespread adoption of our high sensitivity test,” said Dr. James A. Hayward, president and CEO, Applied DNA. “We are actively engaged with clinical laboratories nationally with which our opportunities for assay kit contracts are bolstered by the addition of an RT-PCR system in wide use by the diagnostics industry. Additional planned amendments, we believe, will further differentiate our assay in the marketplace and to operators of clinical diagnostic labs.”
Separately, the Company announced that an inspection report from the State of New York Department of Health (DoH) following the DoH’s initial inspection of Applied DNA Clinical Laboratories, LLC (ADCL) on October 7, 2020, highlighted deficiencies in ADCL’s clinical standard of practice at the time of inspection that require remediation prior to the submission of a re-inspection request. The Company expects to complete remediation actions during the first calendar quarter of 2021. In the interim, ADCL’s safeCircle™ platform, its pooled COVID-19 surveillance testing program that does not require CLEP-CLIA certifications, is leveraging infrastructure designated for diagnostic testing to support safeCircle clients and Applied DNA’s internal surveillance testing program for employees.
“While disappointed with the push-out in our CLEP-CLIA certification timeline, our pooled surveillance testing platform can generate more revenue per pooled sample comprising 5 individuals than from the diagnostic testing of 1 individual in the same amount of time and using the same personnel, procedures, and equipment,” concluded Dr. Hayward. “Surveillance testing is readily scalable, and in recent weeks, we have concentrated our efforts on ramping up surveillance testing capacity. Our sales efforts are focused on tapping into the need for consistent, ongoing, and high sensitivity PCR-based COVID-19 testing that is becoming as foundational to stopping the spread of the virus as masks, handwashing, and social distancing. We believe the value of our safeCircle platform is that its sensitivity allows our clients to identify and isolate infected populations early – in many cases before population members suspect they are ill – to help break the chain of transmission that could otherwise fuel the exponential growth of COVID-19.”
ADCL’s pooled surveillance testing platform, known as safeCircle™, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.
The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Company is offering pooled surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
Source: Company Press Release