Subsidiary to Advance Commercial Development of Diagnostic Tests for Virology, COVID-19, Oncology
Currently in Negotiations for First COVID-19 Testing Contracts; Anterior Nasal Swabs to Make Testing More Accessible

STONY BROOK, N.Y. July 9, 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, and pre-clinical nucleic acid-based therapeutic drug candidates, today announced the formation of a wholly-owned subsidiary, Applied DNA Clinical Labs, LLC (“ADCL”), dedicated to the commercial development of its tests in Virology, for the detection of COVID-19, and in Oncology, for the detection and enumeration of invasive Circulating Tumor Cells (iCTCs). With the formation of ADCL, the Company is executing on a strategy to expand its market reach through value-added services complementary to a growing portfolio of diagnostic assays attractive to a broader number of qualified labs. ADCL allows Applied DNA to be a direct beneficiary of its own diagnostics development beyond the sales of kits to qualified laboratories, and provides the clinical sampling framework necessary to obtain the data required by State and Federal regulatory authorities to develop and improve diagnostics and vaccines in the face of a pandemic with rapidly shifting genetics and infectious behavior.

In mid-May, Applied DNA received Emergency Use Authorization (“EUA”) for a high sensitivity, high-throughput complex molecular test for SARS-CoV-2, the coronavirus that causes COVID-19. The Linea™ COVID-19 SARS-CoV-2 Assay Kit is a real-time polymerase chain reaction (RT-PCR) test for the qualitative detection of SARS-CoV-2 RNA in respiratory specimens. It provides a high-throughput solution to help laboratories address the urgent need for patient testing during the Coronavirus pandemic.

The Company also announced that  the amendment of its EUA was approved by FDA to include extraction and concentration of the viral RNA by a magnetic method of nucleic acid extraction that lends itself easily to high throughput scaling with robotics and diversifies the two extraction methods already covered by the existing EUA. A series of EUA amendments are planned to introduce automation for increased throughput and accuracy, gain approval for additional RNA extraction methods and PCR devices to expand the footprint where our EUA assay can be used, develop point-of-care testing and simplify sample acquisition from patients.

Commenting on the amendment,  Dr. James Hayward, president and CEO of Applied DNA, said, “We are extremely grateful to our collaborators at Stony Brook University Hospital and to the FDA for their guidance during the development and validation of our Linea COVID-19 Assay Kit.  Our goal is to service the COVID-19 patient community and their families, and to facilitate the reopening of universities and businesses with reliable, well-tested science. The demand for COVID testing is diverse, from asymptomatic patients and those in the early stages of disease, to the commercial imperative to operate.”The Company believes that as the demand for testing grows and diversifies, the existing approval of the Company’s Linea COVID-19 Assay Kit for use with anterior nasal swabs will facilitate uptake by certified testing labs.  As opposed to nasopharyngeal swabs, anterior nasal swabs only enter less than 1 inch into the nose, allowing for sampling with minimal irritation or discomfort. Additionally, anterior nasal swabs may be self-collected at a healthcare location or collected by a healthcare worker.

Dr. Hayward continued, “With anterior nasal swabs, we believe patient compliance is not an issue. This is a simple approach to early testing, repetitive testing if begun early in infection, or high-frequency testing, such as in schools, universities, government office, and companies struggling with reopening. When combined with our high-sensitivity and high-throughput Linea COVID-19 Assay Kit, we believe the combined platform to be well suited to combat both the healthcare and economic challenges of the pandemic.”

ADCL, the Company’s new subsidiary was formed to enable clinical testing of patient specimens using methods developed by the Company’s research teams.  Access to clinical specimens will also facilitate more rapid development of improvements and new assays.  All of these continuous improvements are designed to help drive sales to other approved testing labs.

ADCL was also formed to facilitate the use and development of the Company’s Liquid Biopsy platform for detecting iCTCs in the blood of cancer patients, far simpler and safer than surgical or needle biopsies, and is already in use under contract in a Phase III clinical trial of a promising drug for the treatment of Stage IV pancreatic cancer.  The trial involves 3,000 samples and the quantification of metastatic cancer cells in the blood.  Dr. Hayward continued, “Eventually, with the utility of ADCL, we plan to seek regulatory approval for our iCTC assay and add it to the tools used in modern oncology to ensure better patient outcomes.”

The Company has obtained its Permanent Facility Identifier for ADCL, has hired a New York State Licensed Clinical Laboratory Director for Oncology and Virology and Certified Laboratory Scientists, and has applied for a license from the New York State Department of Health.

There can be no assurance that this license will be obtained, or that FDA will maintain the Emergency Declaration that enabled the EUA program for COVID-19 diagnostics.  There can be no assurance that the Company will obtain approved 510K status (or other necessary regulatory approval) for its COVID-19 In Vitro Diagnostics in the event that the Emergency Declaration is lifted. In addition, the Company’s iCTC assay is currently limited to RUO (Research Use Only), and there can be no assurance that the Company will obtain the necessary regularly approval for its iCTC assay to expand its use outside of RUO limitations.

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’.

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 diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies,  the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies or New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020 and May 14, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

STONY BROOK, N.Y. – June 26, 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, is set to join the Russell Microcap^® Index (the “Index”) at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the U.S. market opens on June 29, according to a preliminary list of additions posted on June 19 to the Russell Reconstitution website.

Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“Inclusion into the Index benefits our shareholders by elevating the Company’s visibility within the global investment community in a year in which the opportunities for our linear DNA platform as a means to rapidly manufacture nucleic acid-based therapies at large scale are potentially enhanced by the global pandemic. Beyond our COVID-19 development efforts that include the co-development of vaccine candidates with Takis Biotech and our FDA EUA-approved diagnostic assay kit, we believe that our linear DNA platform resides at the cutting edge of modern medicine with applicability to life-saving therapies, such as engineered T cell (CAR T) therapies and gene therapies,” said Dr. James A. Hayward, president and CEO of Applied DNA Sciences.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

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’.

About FTSE Russell:
FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group.

For more information, visit www.ftserussell.com

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 therapeutic or 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 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 or equivalent foreign regulatory agencies, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020 and May 14, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com

Funds to be Used for Manufacturing Capacity Expansion of Commercially Available Testing Kit and to Support Pathway to Production of Vaccine Candidate(s) for Clinical Trials

STONY BROOK, N.Y. – June 9, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company,” “our”) announced today it secured a $40,000 economic development grant from National Grid to support the Company’s efforts associated with the manufacture of COVID-19-related therapeutics and diagnostics programs. National Grid is one of the largest investor-owned energy companies in the U.S. and serves more than 20 million customers throughout New York, Massachusetts, and Rhode Island.

National Grid’s grants focus on supporting businesses that make critical products for healthcare providers, governments, and other community organizations to navigate through the COVID-19 pandemic. National Grid collaborates with New York State Manufacturing Extension Partnership centers to evaluate business need and offer funding of up to $40,000 to reimburse recipients for costs associated with the transition, upgrade, and implementation of lean manufacturing principles at their existing facilities in the fight against COVID-19.

“We are grateful for National Grid and New York State’s focus on the Long Island community in this time of crisis. This funding will be used to increase our capacity to deliver quantities of our RT-PCR test for COVID-19 that was recently approved under Emergency Use Authorization by the FDA for clinical use, and to support the pathway toward human trials of selected vaccine candidates we have jointly developed with Takis Biotech” said Dr. James Hayward, president and CEO at Applied DNA. “Our orchestrated approach to our development programs aimed at vanquishing COVID-19 we believe is unique, and we share a deep motivation as fellow Long Islanders to support local communities and governments, that are working tirelessly to manage within the pandemic.”

More information on the National Grid grant program is on its website at www.shovelready.com. More information about Applied DNA’s COVID-19 programs are on the Company’s website at www.adnas.com.

About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics 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’.

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, the unknown duration of an EUA approval, disruptions in the supply of raw material 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 report on Form 10-Q filed on February 6, 2020 and May 14, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program contact: Judy Murrah, Applied DNA, 631-240-8819, judy.murrah@adnas.com

STONY BROOK, N.Y. – June 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 provided an update related to the development of linear-DNA form of COVID-19 vaccine candidates with development partner Takis Biotech (“Takis”). Subsequent to the Company’s announcement on May 4, 2020 that first injections of plasmid-based DNA vaccine candidates developed by Takis produced neutralizing antibodies in test animals, linear DNA versions of the vaccine candidates manufactured by Applied DNA began dose-response trials the results of which the Company expects to publish in June 2020.

The companies’ development program utilizes the plasmid-based DNA templates to determine baseline results for the efficacy of the vaccine candidates in preclinical animal models. Based on previous studies with its linear-DNA, Applied DNA anticipates similar results from its linear DNA versions of the vaccine candidates in preclinical animal models with the potential added advantage of reduced risk of antibiotic resistance and genomic integration, and speed of production.

“Our preclinical study with Takis on the linear-DNA form of the vaccine candidates is progressing as planned and we eagerly await the results,” stated Dr. James A. Hayward, President and CEO of Applied DNA. “We believe that our linear DNA approach to vaccines is a novel means of combating emerging pandemics. If found to be as efficacious as the plasmid-based templates, we and Takis will move to engage a third-party to conduct toxicology studies to generate the data necessary for potential human clinical trials of the linear-DNA vaccines. Applied DNA and Takis are working together to contribute to the fight against the deadly COVID-19 pandemic.”

Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of Takis Biotech, said, “The imminent results of the linear DNA versions of our vaccine candidates are a crucial next milestone in our efforts to meet the threat to global public health posed by COVID-19. We are firm believers in the use of PCR amplicons as an emerging technology for DNA vaccines.”

There can be no assurance that the linear-DNA or plasmid vaccine candidates will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that a vaccine candidate can be manufactured in large quantities or that third parties with an established presence in vaccine distribution, compliance and marketing will enter into an agreement with the Company or Takis. Positive results in animals may not be predictive of human outcomes after DNA vaccination. In addition, numerous other SARS-CoV-2 human vaccines are under development by other third parties and even if one or more of the Company’s and Takis’ vaccine candidates are successful, it may generate only limited revenue and profits for the Company.

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.LinearDNA™ is a trademark of Applied DNA Sciences, Inc.

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’.

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, the unknown duration of this or any EUA approval, disruptions in the supply of raw material 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 report on Form 10-Q filed on February 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, LHA Investor Relations, 212-838-3777, shurry@lhai.com  

STONY BROOK, N.Y., May 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 diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, announced that Dr. James Hayward, president & CEO, will participate on a panel titled ‘COVID-19 Testing and Monitoring’ at 12:15 p.m. ET on Wednesday, May 27, 2020 as part of Maxim Group’s COVID-19 Virtual Conference Series. The panel will be moderated by Jason McCarthy, Ph.D., Maxim Group Senior Managing Director, Biotechnology.

To RSVP for the virtual conference, please click through: Maxim COVID-19 Virtual Conference Series. A slide presentation to be used by Dr. Hayward during the panel will be available to interested parties on the “Investors” section of Applied DNA’s website at https://adnasprod.wpengine.com/molecular-based-security/investors/ at the start of the panel.

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.

LinearDNA™ is a trademark of Applied DNA Sciences, Inc.

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’.

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, the unknown duration of this or any EUA approval, disruptions in the supply of raw material 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 report on Form 10-Q filed on February 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, LHA Investor Relations, 212-838-3777, shurry@lhai.com

 

 

Pharmaceutical excipient firm Colorcon has launched its on-dose authentication system SoteriaRx, which it says can help protect patients from potentially harmful drugs, and drugmakers from reputation-damaging counterfeits.

The platform of physicochemical identifiers (PCIDs) – a term coined by the FDA in guidance published several years ago – means that a medicine can be checked for authenticity anywhere in the supply chain, even if it has been removed from its packaging, says the company.

Colorcon has built SoteriaRx on the back of collaborations with TruTag Technologies and Applied DNA Sciences, which gave it access to silicon dioxide and DNA-based taggants, respectively, that are both Generally Recognised as Safe – or ‘GRAS’ – which means they can be incorporated in ingested products.

STONY BROOK, NY, May 18, 2020 — Stony Brook University now has access to a new highly sensitive clinical test for COVID-19. The new testing protocol, developed in collaboration with scientists at Applied DNA Sciences, received FDA Emergency Use Authorization (EUA) for a unique assay, which detects RNA of SARS Cov-2, the novel coronavirus that causes COVID-19. 

The EUA was based on clinical studies performed in the Molecular Pathology Laboratory of Stony Brook University Hospital (SBUH), directed by Dr. Silvia Spitzer and supported by Pathology resident, Dr. Karen Bai, Medical Scientist Training Program (MSTP) student, John Yuen as well as several other graduate and MSTP student volunteers.

According to Dr. Kenneth Shroyer, Chair of the Department of Pathology, the efforts put forth by the team provided the FDA with the necessary evidence demonstrating the new RNA assay is highly sensitive and specific and thus, could provide another tool that could be deployed to perform COVID-19 testing for patients at Stony Brook University Hospital.

The U.S. Food and Drug Administration (FDA) granted emergency use authorization to several developers of molecular tests, including Hologic’s high-throughput Aptima SARS-CoV-2 assay, according to the FDA’s website.

Separately, the FDA also granted EUA to GeneMatrix for its NeoPlex COVID 19 Detection Kit and Applied DNA Sciences for its Linea COVID-19 Assay Kit. Both test kits are designed to run on real-time PCR instruments.

By HospiMedica International staff writers

Applied DNA Sciences Inc. (Stony Brook, NY, USA) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the clinical use of the company’s patent-pending Linea COVID-19 RT-PCR test.

The Linea COVID-19 assay kit is an rRT-PCR (reverse transcription, Real Time Polymerase Chain Reaction)-based assay designed to detect specific highly conserved target sequences of the SARS-CoV-2 Spike (S) gene.