QIAGEN achieves ISO certification for state-of-the-art quality in forensics
Assuring the highest accuracy in human identity testing for law enforcement and other uses
Hilden, Germany, and Germantown, Maryland, October 02, 2017 – QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its manufacturing and supply chain for consumables and other products for forensic and human identity testing has been certified by Bureau Veritas, a leading inspection agency, as meeting the latest international standards for products used in forensic testing. QIAGEN is a global leader in molecular testing solutions for human identification and has actively supported the development of global forensic standards. In pursuit of continuous improvement, QIAGEN has a long history of working with experts in forensic sciences and law enforcement to upgrade requirements designed to minimize the contamination of samples and to ensure the highest level of accuracy in DNA fingerprinting.
The Bureau Veritas certification represents a seal of approval that QIAGEN complies with the latest standard, known as ISO18385:2016, adopted to prevent contamination of products for DNA casework and reference databases. The requirements cover the manufacturing of products used in the collection, storage and analysis of human DNA during forensic testing, including sampling kits such as swabs, containers and packaging, and consumables used in the analysis of DNA samples by forensic laboratories.
“QIAGEN is a pioneer in developing international standards for forensic testing. DNA fingerprinting is essential to the modern justice system – and the results of forensic tests can have very significant consequences. We are very proud to have achieved this third-party confirmation that the manufacturing of our forensic workflows meets the state-of-the-art ISO standards for reliability and quality,” said Dr. Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area. “The certification documents that QIAGEN inspection and documentation of controls as well as manufacturing processes are designed to ensure fail-safe accuracy of our sample kits, forensic assays and other products. We are very proud to deliver industry-leading quality in our forensic testing solutions. Our mission is to ensure that stakeholders of the legal system can with great confidence rely on QIAGEN’s Forensic DNA grade products.”
The latest ISO standards were adopted to eliminate the potential for contamination through introduction of DNA from a source other than the person or sample being tested. Because DNA profiling assays are designed to detect even the tiniest amounts of genetic material in ‘trace’ evidence, contamination could interfere with positive identification or cause misidentification – undercutting an important law enforcement tool and possibly endangering lives. The need for accuracy applies to casework samples, such as DNA collected from a knife handle or cigarette butt at a crime scene, and to reference samples from persons arrested or convicted of crimes, routinely collected and databased to help investigate future crimes.
In the most famous case of contamination, traces of DNA were found at 40 crime scenes in Europe over a 16-year period, including six homicides – leading investigators to suspect that an unknown female serial killer was at large. She was nicknamed “the Phantom of Heilbronn,” a town in Germany where one of the murders took place. The only connection between the crimes was the DNA. In 2009, after exhaustive investigation, detectives found that DNA recovered at various crime scenes was already present on the cotton swabs that had been used for the collection of the samples. The detected DNA had come from a woman who worked at one of the factories of a supplier of the cotton swab products. The "Phantom" serial killer therefore did not exist. Subsequently, international experts in forensic science and law enforcement developed the ISO18385:2016 standard to provide process and quality standards to control for contamination.
In announcing the certification of QIAGEN’s production, the international inspection and testing agency stated: "Bureau Veritas was pleased to work with QIAGEN to review QIAGEN's management system compliance to the ISO18385:2016 standard for production of human identity testing consumables and products. Bureau Veritas found QIAGEN's Management System to be in accordance with the requirements of the ISO18385:22016 with a high level of conformance demonstrated."
QIAGEN is a global leader in Sample to Insight solutions for human identity and forensic testing. Forensic DNA grade products support the entire workflow with manual and automated methods. QIAGEN's high-quality instruments and chemistry provide the required speed, precision and reliability.
Investigator® kits for forensic, human identity and paternity testing are used in casework analysis during criminal and other investigative work, to rapidly and reliably generate DNA profiles from blood, buccal swabs and forensic stains. QIAGEN’s PCR-based human DNA quantification and identification assays and high-quality analytical software provide accurate, integrated analysis and quality control for laboratories. For more information, visit http://www.qiagen.com/us/products/human-identity-and-forensics/.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of June 30, 2017, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).