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.

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’.

Repayment Funded by Warrant Exercise of 318,000 Warrants Issued in Connection with November 15, 2019 Underwritten Public Offering

STONY BROOK, N.Y. – October 8, 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, today announced that it entered into an agreement (the “Agreement”) with the sole holder (the “Holder”) of its outstanding July 16, 2019, secured convertible notes (the “Notes”) for the repayment in full of the Notes, in an aggregate amount of approximately $1.7 million, representing the outstanding amount of the Notes plus interest through the scheduled maturity of the Notes. In conjunction, affiliates of the Holder will exercise warrants issued as part of the Company’s November 15, 2019, underwritten public offering (the “2019 Warrants”) for total proceeds to the Company of approximately $1.7 million. Not all of the Holder’s 2019 Warrants will be exercised in connection with the repayment of the Notes.  As a result of the repayment of the Notes, approximately $1.5 million of debt and liabilities will be extinguished from the Company’s balance sheet, leaving the Company debt-free. In addition, the security interests in the Company’s property granted to secure the Notes will be released.

In connection with a warrant exercise agreement with affiliates of the Holder, in addition to the shares of common stock issued upon exercise of the 2019 Warrants by such affiliates, the Company will issue  replacement warrants (the “Replacement Warrants”) to such affiliates of the Holder in an amount equal to one half the amount of the 2019 Warrants exercised in connection with the Notes repayment. The Replacement Warrants have an exercise price equal to the closing price of the Company’s common stock on October 7, 2020.  In addition, until January 5, 2021, if affiliates of the Notes holder exercise additional 2019 Warrants, the Company will issue to such affiliates additional Replacement Warrants in an amount equal to one half the amount of such exercised warrants and with an exercise price equal to the closing price of the Company’s common stock on the date the related 2019 Warrants are exercised. The Replacement Warrants will not be registered nor listed on any exchange but will be the subject of a registration rights agreement pursuant to which the Company agrees to file a registration statement with respect to the common stock underlying the Replacement Warrants.

“The opportunistic elimination of our outstanding Notes preserves our cash balance to fund the execution of our COVID-19 diagnostics and testing strategy that we believe holds the potential to impact our growth trajectory positively,” said Dr. James A. Hayward, president and CEO, Applied DNA Sciences. “Having built a solid strategic foundation and following the receipt of our first commercial contract for our COVID-19 diagnostic assay kits, we are working diligently to commercialize our testing-as-a-service program at our clinical laboratory subsidiary.”

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, potential dilution to common stockholders caused by exercise of the Replacement Warrants, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners diagnostic or vaccine candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (“FDA”) 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 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 its Annual Report on Form 10-K filed on December 12, 2019, as amended and its subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, and other reports it files 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

Stony Brook, N.Y.-based Applied DNA Sciences Inc. reported the signing of a master services agreement (MSA) with Stony Brook University Hospital (SBUH). Under the terms of the one-year MSA, Applied DNA will supply its emergency use authorizated Linea COVID-19 assay kit to SBUH on an as-needed basis. Concurrently, the company reported the receipt of an initial purchase order under the MSA. Terms of the MSA and initial purchase order were not disclosed.

 

Ensures Access to High Sensitivity, 100% Specificity High-Throughput Assay Kit to Meet Testing Needs

STONY BROOK, N.Y. – September 29, 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, today announced the signing of a Master Services Agreement (MSA) with Stony Brook University Hospital (“SBUH”), the largest academic medical center on Long Island, N.Y. Under the terms of the one-year MSA, Applied DNA will supply its EUA authorized Linea™COVID-19 Assay Kit (the “Assay Kit”) to SBUH on an as-needed basis. Concurrently, the Company announced the receipt of an initial purchase order under the MSA. Terms of the MSA and initial purchase order were not disclosed.

Under the MSA, the Company designed and implemented an automated, high-throughput COVID-19 testing workflow in the SBUH clinical lab. The implemented high-throughput testing workflow is a fully integrated offering that includes equipment, software, and services leased through the Company, including robotic RNA extraction, robotic sample preparation, and RT-PCR custom software and interfaces with laboratory information systems. The testing workflow offers the SBUH clinical lab enhanced operational flexibility and an enhanced testing capacity with the Assay Kit. The Company is willing to offer similar equipment arrangements to other diagnostic labs looking for high sensitivity, high throughput testing solutions for COVID-19.COVID-19 diagnostic testing with the Assay Kit can be performed on a variety of PCR and nucleic acid extraction platforms using samples obtained from nasopharyngeal (NP) swabs or less intrusive anterior nasal (AN) swabs. Recent changes in the laws governing Laboratory Developed Tests (LDTs) allow certified laboratories to use the kit to tailor assays within a single certified laboratory for the device platforms they already have on hand. Saliva sampling and pooled testing methods for the Assay Kit have been developed by the Company for scaled Surveillance Testing within communities and organizations.

“Our collaboration and integration of high throughput automation and data systems with SBUH validates our complete solution. We are thrilled that SBUH chose our Assay Kit to meet its ongoing and evolving needs for a highly sensitive, high-throughput PCR-based diagnostic,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Our Assay Kit used in conjunction with the high-throughput workflows implemented by the Company at SBUH’s clinical lab gives SBUH a strong testing infrastructure to enable the testing of multiple affiliated populations, including patients, staff, and our surrounding community.”

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.

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^TM 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.

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 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 or its partners 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, 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.

Addendum: September 14, 2020 – U.S. Customs and Border Protection Officers in Chicago, IL, Seize 500,000 counterfeit N95 Masks. The counterfeit masks were proved by CDC to have inferior filtration capacity, endangering anyone who wore them in a COVID-positive environment.

CertainT to Be Deployed to Ensure Material and Product Authenticity, Origin, Traceability, Sustainability, and Quality

STONY BROOK, N.Y., September 21, 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, today announced it has entered into a supply agreement (the “Agreement”) for its CertainT platform with ITW Pillar Technologies (“Pillar”), a division of Illinois Tool Works (ITW).

Under the terms of the Agreement, Applied DNA will supply SigNature® molecular tags and SigNify® in-field authentication devices to Pillar for use on materials and products treated with Pillar’s patented plasma deposition technology. Said materials and products will carry Applied DNA’s CertainT trademark, representing authenticity, origin, traceability, sustainability, and quality that will bring transparency to Pillar’s customers’ supply chains and enable these customers to promote traceability and trust in the materials used in their products. Pillar’s systems are utilized by many of the leading manufacturers of N95 masks, gowns, and other equipment used by frontline healthcare practitioners. Plasma deposition technology allows for the finishing of textiles that imparts varying enhanced characteristics – wickability, breathability, ink and dye uptake, anti-microbial, hydrophobicity, etc. – that are ecofriendly to apply relative to traditional wet-chemical processes. The Agreement supports Pillar’s strategy to combat the growing issue of counterfeit PPE entering the healthcare supply chain as the COVID-19 pandemic increases demand and has grown to include other materials and products manufactured by Pillar’s customers.

Pillar personnel will be fully trained in the application of the unique molecular tags and in the use of the in-field authentication systems. Pillar will incorporate SigNature molecular tags into textiles including, but not limited to, polypropylene, cotton, recycled polyester, nylon, wool, and viscose for the manufacture of products, including those used in the manufacture of personal protective equipment (PPE). Authentication of all tagged materials and products will be tracked via CertainT’s cloud-based portal for ease of access by Pillar and its customers.

“We believe our partnership with Applied DNA in the deployment of its CertainT platform across our manufacturing lines provides brands and manufacturers the most advanced and secure plasma-based systems available on the market globally. As the standard of proof and need for greater transparency continues to increase, so too does the need to have a scientific basis to support sustainability goals and ongoing commercial programs. Our customers now have the complete solution that gives them formidable brand protection and assurance with forensic certainty,” said Rory Wolf, CEO of ITW Pillar Technologies. “We are especially pleased to offer definitive proof of the authenticity of PPE materials to customers at a time when COVID-19-fueled demand has led to an influx of substandard and falsified product in the healthcare supply chain.”

Commenting on the Agreement, MeiLin Wan, VP, Textiles at Applied DNA, stated, “Pillar represents further adoption of our CertainT platform and another avenue for the commercialization of our supply chain security solutions. Having validated and proven that our CertainT platform can work on a wide range of substrates with Pillar, the advancement in portable testing together with advancements in non-chemical applications for textiles and other materials provides a compelling solution for branded and proprietary products that require a trusted, market-ready solution.”

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 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.

About ITW Pillar Technologies
Founded in 1966, Pillar Technologies leads the industry in new product development for the packaging, converting and plastic film-printing marketplace. As a division of ITW, our company has access to literally hundreds of products manufactured by many business units within the family.ITW businesses serve local customers and markets around the globe, with a significant presence in developed as well as emerging markets. The company has operations in 55 countries that employ more than 48,000 women and men who adhere to the highest ethical standards. These talented individuals, many of whom have specialized engineering or scientific expertise, contribute to our global leadership in innovation. We are proud of our broad portfolio of more than 17,000 granted and pending patents.

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 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 or its partners diagnostic or therapeutic 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 to U.S. FDA or equivalent foreign regulatory agencies, our ability to successfully enter into commercial contracts for the implementation of our CertainT^® platform 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 report 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
Media contact: MeiLin Wan, Applied DNA Sciences, meilin.wan@adnas.com
Media Contact: Rory Wolf, ITW Pillar Technologies, rwolf@pillartech.com

The FDA SARS-CoV-2 Reference Panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The Reference Panel contains common, independent, and well-characterized reference material that is available to developers of SARS-CoV-2 nucleic acid-based amplification tests (NAATs) for which Emergency Use Authorization (EUA) was requested.

Background
During the early months of the Coronavirus Disease 2019 (COVID-19) pandemic, clinical specimens were not readily available to developers of IVDs to detect SARS-CoV-2. Therefore, the FDA authorized IVDs based on available data from  contrived samples generated from a range of SARS-CoV-2 material sources (for example, gene specific RNA, synthetic RNA, or whole genome viral RNA) for analytical and clinical performance evaluation. While validation using these contrived specimens provided a measure of confidence in test performance at the beginning of the pandemic, it is not feasible to precisely compare the performance of various tests that used contrived specimens because each test validated performance using samples derived from different gene specific, synthetic, or genomic nucleic acid sources.

From February through the middle of May, the FDA issued a total of 59 EUAs for IVDs for the qualitative detection of nucleic acid from SARS-CoV-2 based on validation data using contrived specimens derived from SARS-CoV-2 viral RNA. As the pandemic progressed and more patient specimens became available, on May 11, 2020, the FDA recommended in the Policy for Coronavirus Disease-2019 Tests that developers obtain and use patient specimens to validate their tests.

Recognizing the value to healthcare professionals, laboratories, and patients in understanding the relative performance of NAATs for SARS-CoV-2, the FDA obtained live virus in February to develop a reference panel. Reference panels are a fundamental tool for performance assessment of molecular tests, and the use of the same reference material across different tests allows a direct comparison of analytical sensitivity performance across these tests. As was done for the evaluation of NAATs for Zika, the FDA is again providing a tool for a comparative analysis of the performance of different tests. Such comparison has shown to be useful to health care providers and laboratories implementing these tests.

**Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit Results in Table 2A. Click below to read entire article.

STONY BROOK, N.Y. – September 16, 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, preclinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it and Evvivax, S.R.L., a spin-out of Takis Biotech focused on engineered veterinary immunotherapy and vaccines, are expected to initiate a veterinary clinical trial of one of the Company’s five LineaDNA™ vaccine candidates upon approval of the clinical plan by the U.S. Department of Agriculture. The goal of the vaccine trial is to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2 (COVID-19) (a zoonotic disease) infections in companion felines of humans. This veterinary clinical trial will seek to understand the immune response in cats by utilizing a vaccination strategy of interest in people that could yield valuable data for both cats and humans.In addition to curbing feline SARS-CoV-2 infections, the vaccine may have a secondary benefit of preventing transfer of the SARS-CoV-2 virus from cats to their human owners. While no such transfer has been formally documented to date, there is still much that is unknown about the disease and its transmission across species. The veterinary vaccine trial also serves the additional purpose of generating data on larger animals required as part of the Company’s preclinical development work on its vaccine candidates for potential human development.

Veterinary COVID-19 Vaccine Trial Design
The veterinary clinical trial is a New York State-based, single-center trial that intends to enroll 30 healthy domestic feline companion animals and follow them for six months. The study will evaluate domestic feline immune response, safety, and tolerability of the LineaDNA vaccine candidate, which will be injection once per month at 1mg/month for the first three months of the trial. Dosing will be administered intramuscularly via gene electrotransfer utilizing electroporation technology. The primary endpoint is to determine evidence of antibody and T-cell response in the companion felines.The trial will take place at Guardian Veterinary Specialists in Brewster, N.Y., under the supervision of Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS from Veterinary Oncology Services, LLC. Applied DNA and Evvivax will co-sponsor the trial. Applied DNA’s participation is approximately $100,000, and the Company will supply a quantity of the linear DNA vaccine candidate.

Rationale for COVID-19 Linear DNA Vaccine Candidate for Veterinary Use
In an article titled ‘Susceptibility of ferrets, cats, dogs, and other domesticated animals to SARS-coronavirus 2’ published in Science Magazine on May 29, 2020, the authors of the article conducted research that found that “in cats the virus replicated in the nose and throat and caused inflammatory pathology deeper in the respiratory tract, and airborne transmission did occur between pairs of cats”. According to the CDC, roughly 60% of human infectious diseases are zoonotic, such as rabies, Lyme disease, West Nile virus, and MERS, among others. Globally and in the United States, COVID-19 positive cats have been reported in small numbers. The World Organization for Animal Health (OIE) indicates that “infection of animals with COVID-19 virus meets the criteria of an emerging disease.”

Applied DNA’s LineaDNA vaccine candidates for COVID-19 have previously demonstrated evidence of production of antibody and T-cell responses at low doses of linear DNA in preclinical mouse models. The Company believes that linear DNA vaccines have inherent advantages over conventional DNA and RNA vaccines: they contain only the desired therapeutic DNA sequence with reduced risk of antibiotic resistance and genomic integration; they hold the advantages of speed and scalability when manufactured by the Company’s LinearDNA manufacturing platform; they are manufactured at high levels of purity and with very simple means of production; they are much more stable during storage and shipments than RNA-based vaccines which is a practical advantage during a worldwide deployment.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, “Animal health offers an efficient regulatory path with the U.S Department of Agriculture that serves as a second avenue through which to potentially commercialize our linear DNA COVID-19 veterinary vaccine development work while having the ancillary benefit of progressing our human related preclinical development work with the data generated from this domestic cat study. Because animals and people can both be affected by this zoonotic virus, and with much of the world’s COVID-19 efforts centered on humans with very little known about its effects on our closest companions with whom we share our homes, we believe it prudent to pursue this avenue for the therapeutic benefit of animals and humans alike.

“The collaboration between Applied DNA and Takis/Evvivax is a natural outgrowth of cooperation between the companies that has its roots in the field of cancer research with the development of a linear DNA telomerase (anti-cancer) vaccine that was progressed to COVID-19 vaccine development work. We now seek to apply the same linear DNA vaccine candidates, whose results in small animal models echo the effectiveness announced by some of the COVID-19 vaccines already in human trials, to a veterinary vaccine candidate.”

Commenting on the collaboration, Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of Takis Biotech and Evvivax, said, “The holy grail would be to prevent COVID-19 as opposed to waiting for it to start and then treating it. The implications of success of this cat study would be quite large, both for cats and people.”

About Evvivax
Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech (www.takisbiotech.it). Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies. Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax.Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology. More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets. Evvivax is currently seeking investors for further expanding the collaboration with ADNAS and other Institutions.Visit www.evvivax.com for more information.

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.

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 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 or its partners vaccine 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), the 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 or licensure from the U.S. FDA, the 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 have 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, the unknown outcome of any applications or requests to U.S. FDA, USDA, or equivalent foreign regulatory agencies, 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.