STONY BROOK, NY. December 8, 2020. Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that it will release financial results for its fiscal 2020 fourth quarter ended September 30, 2020 after market close on Thursday, December 17, 2020. In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Standard Time that will also be broadcast live over the Internet.

What: Applied DNA’s Fiscal 2020 Fourth Quarter Financial Results Conference Call

When: Thursday, December 17, 2020, at 4:30 p.m. Eastern Standard Time

Where: Via phone by dialing +1-844-887-9402 (U.S toll free) or +1-412-317-6798 (international dialers) or via live webcast.

A telephonic replay of the conference call will be available for one week and may be accessed by calling +1-877-344-7529 (U.S. toll) or +1-412-317-0088 (international dialers) with the passcode 10149831. An archive of the webcast will be available for a period of one year on the ‘IR Calendar’ page of the Investor Relations section of the Company’s website starting within two hours from the conclusion of the live call.

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements
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, our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, 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, sanjay.hurry@adnas.com

Applied DNA Receives Follow-On Orders

STONY BROOK, N.Y. December 7, 2020. Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced the expansion of commercial activities under its multi-year Master Services Agreement (MSA) with Nutrition21 whereby Nutrition21 has transitioned to Applied DNA’s CertainT^® platform to secure its IP-protected portfolio of dietary supplement ingredients. Concurrently, the Company received two follow-on orders for a second year of commercial production, the majority of which is expected to be shipped in the current fiscal quarter. The financial terms of the follow-on orders were not disclosed.

Nutrition21, a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry, is the first to adopt the platform to protect the IP of its ingredients. Utilizing CertainT, Nutrition21 can certify that its licensees use authentic ingredients and in the proper amounts, and also identify IP infringement by non-licensees. A SigNature^® molecular tag is applied to Nutrition21 ingredients to provide evidence of its product dosages in finished products shipped to market. The molecular tag is supported by ongoing quality control testing services for production and high-resolution testing services for products audited in-market. Nutrition21 holds over 100 domestic and international issued and pending patents for its products.

“The expansion of CertainT’s application within Nutrition21 is testament to our platform’s ability to support Nutrition21’s dedication to ensuring confidence in its ingredients portfolio,” said Dr. James A. Hayward, president and CEO, Applied DNA. “With its diverse portfolio of patented health and wellness ingredients, we believe we are in the early stages of an impactful commercial relationship with Nutrition21 and, by proxy, the dietary supplements industry.”

Joe Weiss, President of Nutrition21, stated, “​After an extensive search to replace our current marker technology, we have now transitioned to the CertainT platform. Marketing partners and customers of Nutrition21 can rest assured that we will utilize the CertainT platform to protect them against infringers of our intellectual property, and most importantly, assure consumers that they are getting the Nutrition21 ingredients that are listed on their product label.”

About CertainT
The CertainT^® platform has three technology pillars (Tag, Test, Track), which allows raw materials and products to be tagged with a unique molecular identifier. This identifier can then be tested for its presence as it travels throughout a global supply chain. All the data points associated to tagging and testing are tracked by uploading to a secure cloud database. The platform can be used across industries such as textiles, cannabis, military, leather, fertilizer, pharmaceuticals, personal care.

About Nutrition21, LLC
Nutrition21 is a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry. With a diverse portfolio of patented health and wellness ingredients, Nutrition21 provides ingredient solutions to some of the most successful dietary supplement brands in the marketplace today.

Nutrition21 currently holds over 100 domestic and international issued and pending patents for products with highly marketable claims including: Nitrosigine^®, Velositol^®, Chromax^®, nooLVL^®, and Lepidamax^®. Innovative Ingredients. Real Results

For more information, please visit: www.Nutrition21.com.

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements
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, our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, 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.y 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, sanjay.hurry@adnas.com
Program contact: Judy Murrah, Applied DNA Sciences, 631-240-8819, judy.murrah@adnas.com

STONY BROOK, N.Y. – December 1, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that its wholly-owned subsidiary, Applied DNA Clinical Laboratories, LLC (“ADCL”), will provide its COVID-19 surveillance testing program to the Stony Brook University Seawolves men’s and women’s basketball teams. ADCL’s pooled surveillance testing platform, known as safeCircle™, will aid the safe return to play and will ensure that Stony Brook student-athletes and coaching staff have access to an accurate, painless, and fast COVID-19 surveillance testing program.

Through the end of the calendar year, safeCircle will provide surveillance testing-as-a-service three times a week utilizing Applied DNA’s high-accuracy and high-sensitivity Linea™ COVID-19 Assay Kit (“Assay Kit”). Testing is being conducted using saliva and anterior nasal swab collection systems pooled in groups of five individuals per test. Individuals in positive pools identified by safeCircle surveillance testing will be referred for diagnostic testing.

Dr. James A. Hayward, president and CEO, Applied DNA, stated, “This  agreement demonstrates continued execution on ADCL’s surveillance testing strategy, adds prominent intercollegiate athletic teams to our client base, and elevates safeCircle’s visibility in the tri-state area. With COVID-19 already making its presence felt in national collegiate sports, we hope to serve as a testing model for other sports programs. We are honored to work with the Seawolves this season.”

About safeCircle™
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.

Click through 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 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 saliva and 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.

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements
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 relating to COVID-19 surveillance testing, 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.

Trial Redesigned to Accelerate Development of Clinical Path to Potential USDA APHIS Conditional License for Commercial Veterinary Sales

STONY BROOK, N.Y. – November 30, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, EvviVax, S.R.L. (“EvviVax”), a spin-off of Takis Biotech with expertise in engineered veterinary cancer immunotherapy and targeted vaccines, and Veterinary Oncology Services at Guardian Veterinary Specialists (GVS), a multi-specialty veterinary hospital, announced the receipt of approvals from the New York State Department of Agriculture and Markets and the U.S. Department of Agriculture on an advanced clinical strategy to conduct a previously reported, New York State-based, veterinary trial of a lead LinearDNA™ COVID-19 vaccine candidate. The vaccine candidate is jointly developed by Applied DNA and EvviVax.

Applied DNA, EvviVax, and GVS also announced a redesign of the veterinary trial to allow for an acceleration of the lead candidate’s development path with the end goal of applying for a U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) conditional license to enable commercial veterinary sales for domestic felines.

The goal of the trial remains to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2, the virus that causes COVID-19, in feline companions of humans that would mitigate the animals as a potential reservoir for infections in humans. Domestic felines are a known COVID-19 reservoir and can transmit the virus to other felines. No transmission back to humans has been documented, though the scientific possibility remains given the virus’s zoonotic origin. The trial will take place at GVS in Brewster, N.Y., and is expected to begin within the next 90 days.

The trial will now recruit a smaller number of healthy domestic feline companion animals that will receive two doses of the vaccine candidate and follow the enrolled cohort for up to six months. The trial’s primary endpoint is to demonstrate the safety and immunogenicity (detection of neutralizing antibodies and T-cell response) of the vaccine candidate in domestic felines. The vaccine candidate previously yielded strong antibody and T-cell responses even at very low doses in mice.

Trial Supervising Investigator and Diplomate of the American College of Veterinary Internal Medicine, Dr. Joseph Impellizeri, of GVS, stated, “By studying the immune response after immunizing an important host that resides with human counterparts, we hope to understand better the potential clinical response against the virus using a specially designed vaccine and delivery system that may translate to both human and animal protection.”

Accelerated Development of Clinical Path
The redesigned trial allows for immunologic data to be gathered faster across a smaller cohort that would also support the near-concurrent pursuit of a parallel trial (the “proposed trial”) currently being finalized to advance further data by challenging an additional cohort in a controlled environment with the lead vaccine candidate. Upon seroconversion, the vaccinated felines would then be placed among an infected COVID-19 feline cohort. The rates of transfer of the infection among the vaccinated cohort will be studied with a planned endpoint of revealing the vaccine candidate’s overall efficacy against active disease. The data from the redesigned and proposed trials may also provide additional support for requisite toxicology and bio-distribution studies to potentially initiate human SARS-CoV-2 vaccine candidate trials.

On the assumption that both trials’ primary endpoints are met, the Company and EvviVax expect to apply for a USDA APHIS conditional license (9 CFR 102.6) for a LinearDNA COVID-19 vaccine candidate for domestic felines. Conditional licensure is afforded to products that meet emergency needs, such as the COVID-19 outbreak, and potentially accelerates the vaccine candidate’s time-to-market.

“In accelerating our vaccine development program for veterinary application, we seek to elevate our work with EvviVax in the emerging field of SARS-CoV-2 susceptibility in animals,” said Dr. James A. Hayward, president and CEO, Applied DNA. “With the initiation of the redesigned veterinary trial, we progress towards potentially commercializing our lead LinearDNA vaccine candidate for use on domestic felines while also generating valuable complementary data for potential human COVID-19 vaccine candidate trials and charting a possible development path to other animals, such as mink. The virus’s impact on farmed mink populations globally has been especially devastating and has resulted in the collapse of  Denmark’s $800 million mink fur industry. Further, mink-linked SARS-CoV-2 virus mutations identified in humans have now spread to at least seven countries. Should our veterinary COVID-19 vaccine gain conditional licensure, we believe it could have significant economic and public utility.”

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements
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 therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) 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, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use,  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, sanjay.hurry@adnas.com
Program Contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, brian.viscount@adnas.com

STONY BROOK, N.Y. – November 27, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that it is scheduled to participate virtually in the Imperial Capital 2020 Security Investor Conference on Thursday, December 3, 2020. Dr. James A. Hayward, chief executive officer, will present at 10:45 a.m. EST that day and host one-on-one meetings throughout the day.An archived webcast will be available within 24 hours of the live presentation on the “IR Calendar” section of the Applied DNA Investor Relations page at adnas.com.

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

STONY BROOK, N.Y. November 12, 2020. Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that it has secured a blanket purchase order from an existing customer for its Linea™ COVID-19 Assay Kit (the “Assay Kit”) and consumables to conduct 10,000 tests. The Company has already shipped a portion of the purchase order in the current fiscal quarter ending December 31, 2020. The balance of the purchase order is expected to be delivered in the current quarter. The Company anticipates recurring purchase orders for Assay Kits and consumables from the customer.

The Assay Kit may be used for pooled surveillance testing by non-CLIA and CLIA certified laboratories or by CLIA-certified laboratories for molecular diagnostic testing. The Assay Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for use as a molecular diagnostic test in May 2020. Pursuant to the EUA, the Assay Kit is authorized for use by CLIA-certified laboratories in the United States 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 Assay Kit is authorized to run on ThermoFisher Scientific’s QuantStudio™ Dx Real-Time PCR Instrument and QuantStudio™ 5 Real-Time PCR System under an amendment to its EUA. Each PCR device is capable of performing 400 to 800 tests in a 24-hour period. The Company has applied for an additional amendment to its EUA that would extend the authorized use of its Assay Kit to ThermoFisher Scientific’s Applied Biosystems™ 7500 Real-Time PCR System, a widely used RT-PCR system that has the capacity to perform a similar number of tests to the QuantStudio 5 and QuantStudio Dx in a 24-hour period.

About the Linea™ COVID-19 Assay Kit
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 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.

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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements
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, sanjay.hurry@adnas.com
Program contact: Brian Viscount, Applied DNA Sciences, 631-240-8877, brian.viscount@adnas.com

Program to Support Weekly Testing of Up to 9,000 Faculty and Staff at Peak Operations, Equates to Use of Approximately 1,800 Tests per Week; Applied DNA Receives Initial Stocking Order Under Master Services Agreement

STONY BROOK, N.Y. – November 10, 2020 – Applied DNA Sciences, Inc., (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea™ COVID-19 Assay Kit (the “Assay Kit”) has been selected by Stony Brook University Hospital (SBUH) for use in SBUH’s newly launched COVID-19 surveillance testing program (the “Program”). At peak operations, the Program will utilize frequent pooled testing to enable the early detection and response for potential COVID-19 cases across the 9,000-member faculty and staff of SBUH and Renaissance School of Medicine. In this COVID-19 surveillance testing modality, the Company expects to provide up to 1,800 (5 individuals per pooled test) of its Linea™ COVID-19 tests per week.

Applied DNA has received an initial stocking order under its Master Services Agreement (MSA) with SBUH for 3,400 tests and related consumables to enable the pooled testing of 17,000 individuals. The Company expects the receipt of recurring purchase orders for Assay Kits and consumables for the Program.

The Program is modeled after the Company’s proprietary safeCircle™ platform, a pooled COVID-19 surveillance testing program developed and used in-house by the Company’s Applied DNA Clinical Laboratories (ADCL) subsidiary. safeCircle utilizes the Company’s Assay Kit in conjunction with an automated, high-throughput testing workflow and equipment, software, and services to return pooled surveillance test results typically within 24 hours.

“Workplaces, classrooms, and communities are beginning to recognize pooled surveillance testing as an effective and cost-efficient means of monitoring virus activity at local, state, and national levels. Offering our high sensitivity Assay Kit for use in a surveillance testing modality creates additional sales opportunities,” stated Dr. James A. Hayward, president and CEO, Applied DNA. “We can service burgeoning demand for surveillance testing in-house at ADCL, and as we recently reported, the activity level in our sales pipeline is such that we are in the process of expanding its surveillance testing capacity. We can also empower any laboratory equipped with authorized equipment to launch their own pooled COVID-19 surveillance testing capacity through the implementation of the safeCircle platform.”

Concluded Dr. Hayward, “It is our privilege to work alongside SBUH on our mutual goal to mitigate COVID-19 spread in our community.”

About safeCircle™
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.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About the LineaT™ 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 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 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.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

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.

Forward-Looking Statements
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.

What is pooled surveillance testing?
Pooled surveillance testing does not require a prescription and looks for infection within a defined population or community and can be used for making health management decisions at the population level. Diagnostic testing, on the other hand, does require a prescription and can be more expensive and time-consuming because it looks for the occurrence of COVID-19 at the individual level. The economics of this tradeoff are enhanced with pooled-sample surveillance testing particularly suited to populations with low (<5%) COVID-19 positivity rates.

Which testing protocol was used?
Our test is comprised of an RT-PCR assay using robotic extraction and plate assembly, followed by RT-PCR analysis on a Thermo Fisher QuantStudio Dx.  This laboratory workflow yields results within 3-4 hours of sample arrival at our laboratory. The assay targets two viral targets and one human RNA target, the latter to measure the quality of the patient sample, in a single-well multiplexed assay. The utilized assay was issued Emergency Use Authorization by FDA in mid-May for diagnostic testing and was shown to be extremely sensitive with a lower limit of detection of a single virus per microliter. In fact, analysis of a blinded FDA Reference Panel of pathogens at various dilutions yielded a high ranking against other COVID-19 assays with essentially 100% specificity and 100% sensitivity.  There is no cross-reactivity with any other respiratory pathogens known to infect humans.  Analysis in silico demonstrated sensitivity of the assay to over 20,000 mutations in SARS-CoV-2, the virus that causes COVID-19.There have been no known instances of false positives or false negatives in our pooled surveillance testing. However, during validation, our assay’s high degree of sensitivity did display discordant results on biobanked samples from a third-party lab that had previously tested negative utilizing another third-party EUA authorized assay.  When the samples were tested using a third sensitive EUA RT-PCR assay, we found our assay detected more than 25% false negative results originally recorded using the original EUA authorized assay.

How was the cohort managed?
Each member of the cohort was guided by the sponsor to follow CDC guidelines for wearing masks, hand and surface sanitization and social distancing. The sponsor was especially meticulous and practiced sanitization of food packaging surfaces and quarantining of food before consumption. Simply stated, this cohort was and is aware of the infectious quality of COVID-19 and used safe practices well above the norm.

Daily pooled surveillance testing was performed on the cohort according to CDC guidelines. Saliva samples were self-collected. Pools of equal aliquots of the saliva from 5 individuals whose identity was anonymized by the sponsor, were subjected to viral lysis before RNA extraction, plate assembly and RT-PCR analysis. causes COVID-19.

What was the result?
On October 2, a pool containing one of the cohort’s saliva sample yielded a very weak signal for one of the two COVID-19 targets.  Detection of the weak signal occurred after 38 PCR cycles, (if a signal is not seen within 40 cycles on our assay, the sample is presumed negative). Putting this in perspective, 38 cycles correlates to a signal amplification of 275 billion times for any signal present in the sample pool.

We next examined the individual saliva samples comprising the pool in isolation to confirm the positive reading, per CDC guidance.  Each individual sample was tested in triplicate. Only one individual sample yielded any indication of SARS-CoV-2 but the signal was again quite weak and inconsistent in the triplicate results.

We requested a fresh pool of samples from the same 5 individuals 24 hours later and detected signal for both viral amplicons at an amplification that was 4,000 times less than the prior signal, indicating a very large increase in viral load within one day. Upon detection of the positive pool, the 5 members of the pool were referred to a physician for individual diagnostic testing and quarantined. Meanwhile we disambiguated (deconvoluted) the pool and identified virus in a single individual’s sample, who subsequently exhibited symptoms of COVID-19 within 3 days.  Daily pooled surveillance tests of the remaining cohort for the following 12 days did not yield any positives, indicating the infection was likely contained by the quick action enabled by surveillance testing.

Conclusion
Proactive, periodic pooled surveillance testing with a high-sensitivity RT-PCR test offers a greater likelihood of detection before virus spreads than testing only symptomatic individuals with rapid diagnostic methods, especially in regions where the COVID-19 testing positivity rate is low. Daily pooled surveillance can pick up very early stage infections that are or rapidly become infectious before less sensitive rapid antigen tests. Pooling saves time and money, and when combined with a sensitive RT-PCR assay, provides critical insight into the COVID-19 penetration even in smaller cohorts.

Announces Completion of Initial New York State Department of Health Inspection of Clinical Lab Subsidiary

STONY BROOK, N.Y. October 12, 2020 – 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, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting, and anti-theft technology, announced that Applied DNA Clinical Laboratories, LLC (“ADCL”), its wholly-owned subsidiary, has secured COVID-19 surveillance testing contracts under its testing-as-a-service (“TaaS”) offering that are estimated to generate more than $1.0 million in total annualized revenue beginning October 1, 2020. The Company’s surveillance testing revenue expectation is contingent on full-term participation by TaaS customers, including:

• Private schools based in Long-Island, N.Y., including Harbor Country Day School. Education customers comprise the bulk of the Company’s current testing volume;
• Several New York State-based small enterprises and private clients.

Unlike diagnostic testing, which looks for the occurrence of COVID-19 at the individual level, surveillance testing looks for infection within a defined population or community and can be used for making health management decisions at the population level.Surveillance testing does not require a prescription. In surveillance testing, pooled test results are returned to the sponsoring organization in the aggregate, not directly to the individual, and may be performed without CLIA certification.Concurrently, the Company is executing on a sales and marketing strategy to build a pipeline of Linea™ COVID-19 Diagnostic Assay Kit (“Assay Kit”) and TaaS opportunities through:

• Outreach to independent and hospital laboratories in COVID-19 hotspots nationally and regionally to offer an additional diagnostic kit supply line;
• Outreach to local laboratories to construct a reference laboratory relationship for overflow testing;
• Deployment of testing at Stony Brook University in accordance with a recently signed Master Services Agreement.

“Our capacity to perform COVID-19 surveillance testing is grounded in self-collection saliva kits and anterior nasal swab kits that are intuitive to use, a highly sensitive PCR-based Assay Kit that can detect as little as one copy of the SARS-CoV-2 genome per microliter in an individual saliva sample, and a high-throughput surveillance testing lab that can return testing results within 24 hours and often on the same day as sampling. When deployed as part of a consistent and ongoing surveillance testing regime, we believe our Assay Kit can help our clients to detect the virus before its median incubation time of 4 to 5 days from exposure to symptom-onset¹. Being able to identify infections early and in a cost-efficient and rapid manner is how surveillance testing gets workers back to work and students back to school,” said Dr. James A. Hayward, president and CEO.“We are beginning to see the first fruits of our Assay Kit and TaaS sales and marketing efforts translate into revenue,” concluded Dr. Hayward. “As we continue to expand our sales pipeline of Assay Kit and surveillance testing opportunities, we believe these efforts can serve as a potentially material driver of our growth supplemented by diagnostic customer testing upon receipt of CLEP-CLIA certification.”

For companies wishing to learn more about Applied DNA Clinical Labs’ surveillance testing program CLICK HERE

Update on CLEP-CLIA Certification
Separately, the Company announced that the State of New York Department of Health (DoH) completed the initial inspection of ADCL on October 7, 2020. Inspection reports are generally filed by the DoH within 4 to 6 weeks of the inspection date. A passing grade would confer onto ADCL DoH’s Clinical Laboratory Program (CLEP) certification under which ADCL can function as a certified clinical lab. CLEP-approved clinical laboratories located in New York State meet Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing and accreditation requirements that would enable ADCL to receive patient samples collected nationally for testing. A failing grade would require ADCL to remediate deficiencies prior to any re-inspection request. The Company offers no timetable for receipt of CLEP-CLIA certifications at this time.

Use of Linea™ COVID-19 Assay Kit for Surveillance Testing
Pursuant to current guidances from the CDC, FDA, and CMS, Applied DNA’s Assay Kit can be marketed for surveillance and research use. Applied DNA has internally validated the Assay Kit for surveillance testing using pooled saliva samples for up to five samples. The Company notes that the use of pooled saliva samples is for surveillance testing only and has not been authorized under the Company’s EUA for the Assay Kit. CLEP certification would enable ADCL to perform the disambiguation of any positive pools identified in the Company’s surveillance testing program.

¹ “Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19)” Centers for Disease Control and Prevention, 10 Sept. 2020, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html

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’.