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LineaRx Signs Agreement with TYME Technologies for Functional ICTC Assay Services in Pancreatic Cancer Trial

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LineaRx Signs Agreement with TYME Technologies for Functional ICTC Assay Services in Pancreatic Cancer Trial

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Demonstrates Growing Interest and Demand for Alternatives to Plasmids as Source of DNA in Pre-Clinical Therapeutic Applications

STONY BROOK, N.Y., November 26, 2019 –  Applied DNA Sciences, Inc. (NASDAQ: APDN; the “Company” or “Applied DNA”) announced today that LineaRx, Inc., the Company’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, has signed a definitive agreement with Tyme Technologies, Inc. to supply the Company’s Vita-Assayinvasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer (the “Agreement”).Under the terms of the Agreement, TYME has the option to purchase from the Company up to 3,000 Vita-Assay kits and associated iCTC analytical and storage services over the course of treatment of up to 250 patients. The potential value of the Agreement is the largest contract to-date for LineaRx, and the largest in the development history of the iCTC assay.

The Company and TYME have previously announced a study demonstrating correlation between the number of iCTCs in a patient’s blood and their disease status, as observed in TYME’s SM-88 Phase II trial for recurrent prostate cancer. The study demonstrated that SM-88 had very encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone was important. The study also showed that reduction of CTCs, an important prognostic indicator, may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88 and other non-hormonal agents.

“We continue to commercialize our Vita-Assay functional iCTC capture assay and iCTC identification technologies, which we recently acquired in August of this year,” said Dr. James Hayward, President, Chairman and CEO of Applied DNA. “We are excited to work with TYME to support their important pivotal stage trial for pancreatic cancer and, together with TYME, to potentially compile additional evidence of iCTC-count correlation with cancer disease status and therapeutic efficacy.”

Dr. Giuseppe Del Priore, Chief Medical Officer of TYME, stated: “We are impressed by the distinguishing character of the iCTC assay developed by LineaRx; they have a functional assay which directly mimics the behavior of metastatic cells in the body, by capturing iCTCs after they invade a cellular adhesion matrix directly from fresh blood. These live metastatic cells can be counted and characterized by the unique biomarkers from LineaRx. iCTCs can be cultured and analyzed by the latest genomic methods.”Dr. Hayward concluded: “Our contract with TYME, and other recent collaborations not yet announced, will, we believe, help advance our understanding of the metastatic process and the underlying genomic changes that accompany late-stage cancers. We believe that an oral cancer treatment like SM-88 may be used as a monotherapy or in combination therapy across multiple cancers and potentially provide an opportunity to also intervene with genetic immunotherapeutic approaches that may one day be delivered via linear DNA.”

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture. Go to www.adnas.com for more information on LineaRx and to learn more about how Applied DNA makes life real and safe. LineaRx is a majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN) 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.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol APDN.

Forward-Looking Statements
The statements made by Applied DNA in this presentation 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 substantial doubt relating to Applied DNA’s ability to continue as a going concern,  the possibility of 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, its ability to penetrate key markets, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product 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, 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 18, 2018, as amended, our subsequent quarterly reports on Form 10-Q filed on February 7, 2019, May 9, 2019 and August 13, 2019, 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, 631-240-8877, brian.viscount@adnas.com

Applied DNA Sciences Reports 14 Development Customers for its Linear DNA Manufacturing Platform

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Demonstrates Growing Interest and Demand for Alternatives to Plasmids as Source of DNA in Pre-Clinical Therapeutic Applications

STONY BROOK, N.Y., November 25, 2019 –  Applied DNA Sciences, Inc. (NASDAQ: APDN, Applied DNA, “the Company”) announced today that LineaRx, Inc., its majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, has grown its customer base to fourteen companies currently testing its linear DNA manufacturing platform for the development of nucleic acid-based therapies and diagnostics.  The Company believes this expansion is indicative of an increasing need for an alternative to plasmids as the source of DNA.

Applied DNA’s therapeutic and diagnostic client/partner base has grown to fourteen companies developing a variety of therapeutic indications including gene therapies, DNA vaccines against infectious agents and cancer, and CAR T therapies with a variety of transfection and transduction technologies, as well as several others using our platform as a template for RNA production and in vitro diagnostics “Not only is the breadth of application expanding, but our clients represent market leaders in their respective industries. Initial evaluations of our linear DNA have yielded encouraging results, and optimization is under way,” said Dr. James Hayward, CEO of Applied DNA.

“Our expansion in the commercial utility of our recent acquired (invasive Circulating Tumor Cells) iCTC-based platform for diagnostics in vitro has also attracted the attention of several companies and research institutions, and we believe these emerging opportunities will aid our growth next year,” added Dr. Hayward.

In fiscal 2020, the Company anticipates continued growth of its LineaRx client-base, while existing clients evaluate performance both in vitro and in vivo through animal studies. The Company is implementing plans to increase its manufacturing capacity and to validate manufacturing and testing procedures in compliance with FDA guidelines. The Company will also begin testing patent-pending technologies that are available for licensing that we believe may deliver higher levels of gene expression and longer functional lifetimes for the expressed proteins, as well as amplicons using episomal replication (in the nucleus, but not integrated permanently into the genome). LineaRx’s clients and partners are continuing to evolve complementary technologies, to determine the best delivery technology for linear DNA with the goal of improved therapeutic and diagnostic performance.

lrx graph

*As of 11/21/19

About LineaRx
LineaRx is commercializing the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture. Go to www.adnas.com for more information on LineaRx and to learn more about how Applied DNA makes life real and safe. LineaRx is a majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN) 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.Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol APDN.

Forward-Looking Statements
The statements made by Applied DNA in this presentation 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 substantial doubt relating to Applied DNA’s ability to continue as a going concern, uncertainties relating to its ability to maintain its NASDAQ listing after December 31, 2019 in light of delisting notices received and its recent hearing, the possibility of 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, its ability to penetrate key markets, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product 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, 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 18, 2018, as amended, our subsequent quarterly reports on Form 10-Q filed on February 7, 2019, May 9, 2019 and August 13, 2019, 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, 631-240-8877, brian.viscount@adnas.com

Make Good Mistakes [PODCAST]

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As the President and CEO of Applied DNA Sciences, James Hayward’s, Ph.D., journey into entrepreneurship didn’t start in business — it started in science. James’ commitment to humanity led to over 20 years in the biotechnology and consumer product industry testing counterfeit goods, and brands by providing innovative, molecular-based technology solutions and services.

James tells our host John his tips on managing teams, why companies shouldn’t be afraid of failure, global effort to ensure the authenticity of products, and why people should make good mistakes.

Applied DNA Sciences Announces Closing of Upsized $12.0 Million Underwritten Public Offering

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STONY BROOK, N.Y., November 15, 2019 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic research, today announced the closing of its previously announced underwritten public offering of 2,285,000 shares of common stock and warrants to purchase up to an aggregate of 2,285,000 shares of common stock. Each share of common stock was sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $5.25 per share and accompanying warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, were approximately $12.0 million, not including any amounts received upon exercise of the warrants.

The warrants are immediately exercisable at a price of $5.25 per share of common stock and will expire five years from the date of issuance. The shares of common stock and the accompanying warrants were sold together in the offering, but were issued separately.

Maxim Group LLC acted as the book-running manager and Joseph Gunnar & Co. LLC acted as a co-manager in connection with the offering.

Applied DNA has granted the underwriters a 45-day option to purchase up to an additional 342,750 shares of common stock and/or warrants to purchase up to 342,750 shares of common stock, at the public offering price less discounts and commissions.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-233830), as amended, previously filed with and subsequently declared effective by the Securities and Exchange Commission (“SEC”) on November 13, 2019 as well as the Company’s subsequent registration statement on Form S-1 (File No. 333-234664), which became effective on November 13, 2019. A final prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Electronic copies of the final prospectus relating to this offering may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol APDN.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of 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 substantial doubt relating to Applied DNA’s ability to continue as a going concern, our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, the possibility of 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, the Company’s 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 product candidates will advance further in the preclinical research or clinical trial process, uncertainties relating to its ability to maintain its NASDAQ listing after December 31, 2019 in light of delisting notices received and its recent hearing, 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 18, 2018, as amended, and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019, May 9, 2019 and August 13, 2019, 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 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

APDN: Traceable DNA-Tagged Leather Supply Chain at Asian Tannery

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By Christopher Hall, November 13, 2019

In 2018, Applied DNA Sciences announced that it was one step closer to creating fully traceable supply chains for leather goods – this year, it appears the tech company’s hard work has paid off. On Tuesday, Applied DNA said it had successfully implemented DNA tagging into one of the world’s largest tanneries, located in Asia.

Applied DNA Sciences Announces Pricing of Upsized $12.0 Million Underwritten Public Offering

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STONY BROOK, N.Y., November 13, 2019 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic research, today announced the pricing of an underwritten public offering of 2,285,000 shares of its common stock and warrants to purchase up to an aggregate of 2,285,000 shares of common stock. Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $5.25 per share and accompanying warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $12.0 million, not including any amounts received upon exercise of the warrants.

The warrants will be immediately exercisable at a price of $5.25 per share of common stock and will expire five years from the date of issuance. The shares of common stock and the accompanying warrants, can only be purchased together in the offering, but will be issued separately. The offering is expected to close on or about November 15, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as the book-running manager and Joseph Gunnar & Co. LLC is acting as a co-manager in connection with the offering.

Applied DNA has granted the underwriters a 45-day option to purchase up to an additional 342,750 shares of common stock and/or warrants to purchase up to 342,750 shares of common stock, at the public offering price less discounts and commissions.

The Securities and Exchange Commission (the “SEC”) declared effective a registration statement on Form S-1 (File No. 333-233830) relating to these securities on November 13, 2019. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745. Before investing in this offering, interested parties should read in its entirety the registration statement that the Company has filed with the SEC, which provides additional information about the Company and this offering.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of 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 substantial doubt relating to Applied DNA’s ability to continue as a going concern, our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, the possibility of 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, the Company’s 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 product candidates will advance further in the preclinical research or clinical trial process, uncertainties relating to its ability to maintain its NASDAQ listing after December 31, 2019 in light of delisting notices received and its recent hearing, 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 18, 2018, as amended, and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019, May 9, 2019 and August 13, 2019, 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 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

Closing the Loop

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The statistics surrounding textile recycling are enough to make anyone with a conscience cringe: Americans toss over 80 pounds of used clothing each year, and 60 percent of clothing ends up in incinerators or landfills within a year.

What’s more, recycling of textiles is virtually non-existent, with less than 1 percent of existing textiles going back into textiles. Given that the total number of garments the average consumer purchased each year increased by 60 percent from 2000 to 2014, a lot clearly needs to change.

In Sourcing Journal’s “Closing the Loop” webinar, Cyndi Rhoades, CEO/founder of Worn Again Technologies and MeiLin Wan, VP, textile sales at Applied DNA, discuss the challenges and solutions of textile recycling, including how companies can buy, sell and design with circularity in mind.

Listen to “Closing to Loop” as we explore:

  • Just why textile and garment-to-garment recycling is so difficult
  • The differences between mechanical and chemical recycling
  • How to design with recycling in mind
  • The importance of traceability and the tools that can be used
  • Solutions for recycling blended fibers
  • The advances of designing with recycled PET
  • The areas most in need of consumer education—and the best ways to teach them
  • Where cost plays into all of this

Speakers:

  • MeiLin Wan, VP, textile sales, Applied DNA
  • Cyndi Rhoades, CEO/founder, Worn Again Technologies
  • Caletha Crawford, publisher, Sourcing Journal (moderator)

The Loop Can’t Close Until Everyone Accepts Responsibility

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The statistics surrounding textile recycling are enough to make anyone with a conscience cringe: Americans toss over 80 pounds of used clothing each year, and 60 percent of clothing ends up in incinerators or landfills within a year.

What’s more, recycling of textiles is virtually non-existent, with less than 1 percent of existing textiles going back into textiles, according to Cyndi Rhoades, CEO/founder of Worn Again Technologies.

In Sourcing Journal’s “Closing the Loop” webinar, Rhoades joined MeiLin Wan, vice president, textile sales at Applied DNA, to discuss the challenges and solutions of textile recycling and how companies can buy, sell and design with circularity in mind. Given that the total number of garments the average consumer purchases each year increased by 60 percent from 2000 to 2014, there’s a lot clearly that needs to change.

Traceability and the Dynamics of ‘Conflicted Cotton’

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Cotton traceability systems can identify the species, geographic origin, and integrity of the fiber as it is produced into finished goods

By Tracey Greenstein, November 8, 2019

Conflicted cotton is an oft-ignored topic in the fashion industry. But as traceability grows as a subject of interest, conflicted cotton – its origins, and the human rights abuses that surround its production processes – is having a comeback of sorts.