– Demand for Testing-as-a-Service Increases–
– Highly Sensitive Pooled Surveillance Testing Platform Demonstrates Ability to Detect Local Infections and Prevent Clusters –
STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19–Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics in vitro, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting, and anti-theft technology, today announced that it plans to boost its COVID-19 testing capacity at Applied DNA Clinical Laboratories, LLC (“ADCL”), its wholly-owned subsidiary, to support the reception to ADCL’s surveillance testing-as-a-service offering enhanced by ongoing sales and marketing outreach efforts amid a national surge in coronavirus cases. Capacity expansion will be achieved through the phased deployment of additional robotic automation that will enable increased surveillance testing throughput by a significant multiple.
“Our emphasis on expanding the throughput of our surveillance testing program is strategic: on average, we can generate more revenue per test with pooled surveillance testing of multiple individuals simultaneously than from diagnostic testing of single individuals only,” said Dr. James A. Hayward, president and CEO, Applied DNA. “Our expansion plans align with a strong response to our sales and marketing programs at both regional and national levels for our surveillance testing. We continue to develop our pipeline of surveillance testing and related Linea™ COVID-19 diagnostic assay kit opportunities and now includes certain athletics programs and the staff and faculty of a large academic institution. Furthermore, we have added numerous new clients since our recent announcement of initial surveillance testing contracts. It is clear to us that our surveillance program is being increasingly seen as a powerful tool to protect classrooms, workplaces, and other populations from COVID-19.”
ADCL’s pooled surveillance testing program, 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 Company has taken delivery from robotics manufacturers to enhance the throughput for COVID-19 testing. (Read more…) Planned expansions include increased production of Applied DNA’s Diagnostic Assay Kit (“Assay Kit”) that powers safeCircle surveillance testing; increased sample pooling operations for high-throughput surveillance testing at ADCL and pooling support at a major academic institution; and in high-throughput viral RNA extraction and plate assembly. The Company has also installed and validated additional PCR instruments that will be deployed in its surveillance testing programs. These validations will also serve as the basis for further amendments to the Company’s EUA authorized Assay Kit for diagnostic testing.
“Recent surveillance testing successes are amplifying the value proposition of safeCircle in the marketplace,” concluded Dr. Hayward. “In recent weeks, we have uncovered early infections in populations and cohorts that had tested negative via rapid antigen tests both immediately before and immediately after our positive surveillance testing. Individuals in these populations subsequently developed symptoms. Given our surveillance testing accuracy, we believe we prevented the development of COVID clusters within these tested populations and cohorts. We look to bring the same capabilities with an expanded capacity to grow our market presence regionally and elevate our profile nationally.”
Surveillance versus Diagnostic Testing
Surveillance testing looks for infection within a defined population and can be used to make important health management decisions at the population level. Specimen collections are conducted via nasopharyngeal or anterior nasal swabs, and via saliva sampling, and pooled. Pooled test results are returned to the sponsoring organization in the aggregate, not directly to the individual, and may be performed without CLIA certification. Surveillance testing does not require a prescription.
In comparison, diagnostic testing looks for the occurrence of COVID-19 at the individual level. Diagnostic testing requires a prescription, and results are returned to the individual or their healthcare provider.
To learn more about how safeCircle can help your community, school, and workplace: safeCircle
About the Linea™ COVID-19 Assay Kit
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 the 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 surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of pooled nasopharyngeal or anterior swabs or saliva 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.
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.
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, 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 or its partner’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 and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, FDA and/or CMS, 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, May 14, 2020 and August 6, 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.
Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8800, [email protected]