FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms
- Diagnostic Kit Authorized for Use on Widely Installed RT-PCR Device and High-Throughput RNA Extraction Robotics; Company Ramps Kit Production in Response -
STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc.. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, and pre-clinical nucleic acid-based therapeutic drug candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that both expands the installed base of PCR equipment platforms that can process the Company’s LineaTM COVID-19 Assay Kit and introduces automation to significantly increase the throughput of the assay by use of robotic RNA extraction.
The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio™ Dx to include Applied Biosystems’ QuantStudio™ 5 Real-Time PCR system (“QS5”). The amendment also authorizes the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-tek Mag-Bind® viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput. The Company believes the amendment can greatly enhance the efficiency of laboratories across the country who adopt the diagnostic kit while expanding by more than tenfold the target installed base of authorized RT-PCR equipment. To match the potential for higher demand, the Company is increasing production of its diagnostic kit.
“Accessibility and turnaround times are two critical metrics for the successful commercial implementation of a diagnostic kit to serve communities affected by the COVID-19 crisis. With this EUA amendment we have accomplished both – a greatly increased installed base of RT-PCR devices upon which our assay can run, and also increased the speed and throughput of our assay through the use of a best-in-breed robotic platform. We appreciate the continued collaboration of FDA in assisting us to improve the availability and throughput of our diagnostic kit,” said Dr. James A. Hayward, president and CEO of Applied DNA. “As COVID-19 infection numbers spike in many parts of the country, we are also moving to increase kit production. We have been investing aggressively in our supply chains and established inventories to deliver greater patient accessibility to testing and for maximal market penetration.”
Michael Mouradian, vice president of Robotics at Hamilton Company, manufacturer of the Hamilton STARlet platform, said, “Our mission at Hamilton each day is to supply advanced liquid handling solutions that support the research and diagnostic testing communities confronting the COVID-19 pandemic.”
“We appreciate the opportunity to work with Applied DNA Sciences to help provide a reliable, reproducible RNA extraction solution,” said Travis Butts, vice president of Omega Bio-tek, manufacturer of the Omega Bio-tek Mag-Bind® viral RNA Express kit. “By partnering with Hamilton, we are able to implement an automated, high-throughput solution that can be deployed quickly and allow customers like Applied DNA Sciences to meet the demand for COVID-19 testing.”
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.
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The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly-traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Applied DNA is a member of the Russell Microcap® Index.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020 and May 14, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Source: Applied DNA Sciences Inc.