The CE-IVD marked PAXgene® Blood ccfDNA tube will be available in Western Europe

FRANKLIN LAKES, NJ and EYSINS, SWITZERLAND, February 21, 2018 – BD (Becton, Dickinson and Company) (NYSE: BDX), a global leader in medical technology, today announced the commercial availability of the CE-IVD marked PAXgene® Blood ccfDNA tube within the European Economic Area and Switzerland (Europe western). The plastic blood collection tube, which includes a proprietary sample stabilization additive and BD Vacutainer® Hemogard™ technology to help protect the safety of healthcare workers, was designed to ensure accurate and reproducible results in blood collection applications. molecular diagnostic tests using circulating free DNA (ccfDNA), such as cancer and non-invasive prenatal testing. The product was developed by PreAnalytiX GmbH, a joint venture between BD and QIAGEN.

Cells, including fetal cells, cancer cells, or cells from transplanted organs, release DNA into the bloodstream. This DNA can be analyzed using PCR or next-generation sequencing to understand the genetic characteristics of a developing fetus, a cancerous tumor, or a transplanted organ from a blood draw. Molecular diagnostic tests using ccfDNA allow doctors to obtain usable biological information without a tissue biopsy or similar invasive test.

The PAXgene Blood ccfDNA tube provides clinical laboratories with a solution to stabilize samples when the sample cannot be processed the same day it was collected. Where standard EDTA tubes require processing within hours before cells die and release genomic DNA into blood plasma (thus modifying the native ccfDNA profile), the PAXgene tube has a unique stabilization chemistry that allows for collection and processing days later, facing a critical logistical hurdle for reference laboratories offering molecular testing outside the hospital setting.

“Many molecular diagnostics companies, particularly in the cancer sector, are developing new tests for patient monitoring and screening. They need a safe and clinically acceptable system for blood collection and ccfDNA processing that is capable of stabilizing a sample so that ccfDNA extraction can occur after the sample has been transferred to another location which is not possible with EDTA tubes,” said Frank Augello, general manager, PreAnalytiX GmbH. “This product will help Western European molecular diagnostics companies offering ccfDNA-based tests grow their markets faster and ultimately help more patients access cutting-edge care. »

“Reducing the potential for preanalytical errors is critical to ensuring the accuracy of molecular diagnostic tests,” said Uwe Oelmueller, Ph.D., vice president, head of sampling technologies for MDx development for QIAGEN, GmbH. “We are confident that the CE-IVD marked version of the PAXgene Blood ccfDNA tube will provide robust safety and reliable and reproducible ccfDNA-based test results, helping to expand access to molecular diagnostic testing in Western Europe.”

Since 2016, PreAnalytiX has marketed a Research Use Only (RUO) version of the PAXgene Blood ccfDNA tube together with the QIAsymphony® PAXgene® Blood ccfDNA Kit as a fully integrated and standardized system covering all steps of the preanalytical workflow from blood collection , stabilization, transport, storage and isolation of high quality ccfDNA. The RUO tube version has the same format and stabilization chemistry as the new CE marked version. The RUO version of the tube will be discontinued as customers adopt the CE-IVD. For more information visit https://www.preanalytix.com/products/blood/ccfDNA/paxgene-blood-ccfdna-tube-ivd-use.

About PreAnalytiX
PreAnalytiX, a joint venture between BD and QIAGEN, develops, manufactures and sells integrated and standardized systems for the sample collection, stabilization and purification of high-quality RNA, microRNA and DNA from human blood, bone marrow or tissue samples. The company serves healthcare institutions, academic researchers, clinical laboratories and the pharmaceutical industry with a broad range of manual and automated products.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of healthcare by improving medical discovery, diagnostics and care delivery. The company supports heroes on the frontline of healthcare by developing innovative technologies, services and solutions that help advance both clinical therapy for patients and the clinical process for healthcare professionals. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of the physician care delivery process, enable laboratory scientists to better diagnose disease, and improve capabilities of researchers to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working closely with customers, BD can help improve outcomes, reduce costs, increase efficiency, improve safety, and expand access to healthcare. In 2017, BD welcomed CR Bard and its products to the BD family. For more information on BD, visit bd. com.

About QIAGEN
QIAGEN NV, a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to obtain valuable molecular information from samples containing the building blocks of life. Our sampling technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Analysis technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant and actionable insights. Automation solutions tie together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers worldwide in the fields of molecular diagnostics (human healthcare), applied testing (forensics, veterinary testing, and food safety), pharmaceutical (pharmaceutical and biotechnology companies), and academic (life science research ). As of September 30, 2017, QIAGEN employed approximately 4,600 people in more than 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statements
This press release contains certain forward-looking statements (as defined by federal securities laws) relating to the PAXgene Blood ccfDNA tube. Forward-looking statements may be identified by the use of words such as « will, » « intent, » « plan, » « believe, » « expect, » or other words of similar meaning. All of these statements are based on BD’s current expectations and involve a number of business risks and uncertainties that could cause actual results to differ materially from the expected results described, implied, or anticipated in any forward-looking statements, including, without limitation, regulatory changes , competition, rapid or unexpected changes in technologies and the ability to gain market. We do not intend to update any forward-looking statements to reflect events or circumstances after today’s date, except as required by applicable law or regulation.

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Contacts:
Gwen Gordon
BD Public Relations
858.812.3724
gwen.gordon@bd.com

Monique N. Dolecki
BD Investor Relations
201.847.5378
monique_dolecki@bd.com