QIAGEN’s Investigator human identity testing products meet new ISO standard
Existing framework allows to immediately offer highest quality DNA products to forensic customers
Hilden, Germany, and Germantown, Md., February 03, 2016 – QIAGEN GmbH today announced that the company’s Investigator sample and assay technology kits for human identity testing and the associated manufacturing facilities meet the requirements of the newly published ISO 18385:2016 standard.
QIAGEN’s Investigator kits, which were developed for forensic, human identity and paternity testing, are used in casework analysis during criminal and other investigative work, and rapidly and reliably generate DNA profiles from blood, buccal swabs and forensic stains. Compliance with the new standard means that only products meeting strictest requirements for absence of exogenous DNA are allowed to leave the QIAGEN manufacturing facilities.
The new international standard, which was developed starting in 2012 with contributions from QIAGEN, was published on February 1. It specifies requirements for the manufacture of products used in the collection, storage and analysis of human DNA during forensic testing. These requirements seek to improve the quality of forensic testing around the world by minimizing the risk of human DNA contamination during the manufacturing process. Manufacturers that comply with the requirements can label their products “Forensic DNA Grade.”
As a result of the publication of the new standard, QIAGEN announced the availability of ISO 18385:2016 Forensic DNA grade products covering the entire workflow of sample and assays technologies, and both manual and automated methods. QIAGEN confirms that all of the associated manufacturing sites are operating under the new standard. The ISO 18385:2016 products continue QIAGEN’s commitment to the highest quality standards. QIAGEN established a forensic-grade quality framework for its Investigator kits in 2013. This framework covered the fundamental quality standards outlined in draft ISO 18385 standards and ensured compliance with all customary contamination exclusion requirements. QIAGEN has been affixing “forensic grade” seals to its Investigator kits since 2014.
“QIAGEN is delighted that our commitment to the highest product quality enables us to immediately offer Forensic DNA grade products that are compliant with ISO 18385:2016,” said Dr. Thomas Schnibbe, Senior Director and Head of QIAGEN’s Global Forensic Business. “Our Investigator sample and assay technology kits have set a new standard for quality in forensic testing in their use around the world. Our Investigator ISO 18385:2016 Forensic DNA grade products continue the long QIAGEN tradition of quality and we are pleased to be able to offer these industry leading kits to customers so quickly after the publication of the new ISO standard.”
QIAGEN is a global leader in Sample to Insight solutions for human identification workflows. The company’s Investigator® STR assay kits incorporate the Investigator® Quality Sensor to evaluate the quality of DNA in each sample, a novel QIAGEN technology that enables labs to decide quickly which evidence may provide valuable results.
No Investigator product component formulation is changing, so customers can continue to use the Investigator products without the need for revalidation. For more information about QIAGEN’s forensic grade quality, please don’t hesitate to go to www.qiagen.com/forensicgrade.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions to transform biological materials into valuable molecular insights. QIAGEN 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 molecular testing workflows. QIAGEN provides these workflows to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of December 31, 2015, 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, markets, strategy or operating results, including without limitation its expected operating 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).