FDA OK's expanded use of Applied DNA's COVID-19 test via further amendment
Nov. 25, 2020 9:08 AM ETApplied DNA Sciences, Inc. (APDN)By: Mamta Mayani, SA News Editor
The FDA has granted a further amendment to Applied DNA Sciences' (NASDAQ:APDN) Emergency Use Authorization (EUA) of installed base of RT-PCR platforms that can process Linea COVID-19 Assay Kit.
The EUA amendment extends the platform authorization from QuantStudio Dx and 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.”
Update on Applied DNA Clinical Laboratories CLEP-CLIA Certification
Separately, the Company announced that an inspection report from the State of New York Department of Health (DoH) highlighted deficiencies in Applied DNA Clinical Laboratories' (ADCL) clinical standard of practice and that it requires remediation prior to the submission of a re-inspection request.
The Company expects to complete remediation actions during Q1 2021.
