QIAGEN and Clinical Genomics partner on liquid biopsies to monitor patients for recurrence of colorectal cancer
Aug 21 2017

QIAGEN and Clinical Genomics partner on liquid biopsies to monitor patients for recurrence of colorectal cancer

Convenient blood test uses novel technology to test for recurrence of tumors by detecting circulating DNA

Hilden, Germany; Germantown, Maryland; and Bridgewater, New Jersey, August 21, 2017 – QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and Clinical Genomics, a private company developing evidence-based diagnostic tools for colorectal cancer, today announced they have implemented the PAXgene® Blood ccfDNA Tube* sample collection in Clinical Genomics’ Colvera™ colorectal cancer (“CRC”) recurrence assay. Colvera, an integrated liquid biopsy solution, is designed to enable easy and accurate monitoring for recurrence of colorectal cancer with a simple blood test collected in a physician’s office.

“The Colvera test represents a unique opportunity for convenient, non-invasive monitoring of colorectal cancer patients by detecting methylated circulating tumor DNA that may indicate recurrence of a cancer. We are pleased to collaborate with Clinical Genomics in expanding the range of benefits made possible through liquid biopsies, which hold great promise for improving the lives of patients in cancer and other fields of medicine,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area.

“We are extremely pleased to use the highly automated QIAsymphony PAXgene Blood ccfDNA collection and sample processing workflow for collection and handling of Colvera samples. As a long-term commercial and research partner of QIAGEN, we have a great deal of confidence in this new solution," said Dr. Lawrence LaPointe, CEO of Clinical Genomics. “We are excited to roll out the PAXgene System as the front-end solution to allow physicians to provide Colvera testing to CRC patients as conveniently as possible. PAXgene allows a simple blood collection at the physician’s office, with no on-site processing required, which is a great step forward from our alternative sample collection methods.”

Clinical Genomics and QIAGEN have demonstrated that PAXgene ccfDNA yield and Colvera assay performance is equivalent to the performance from blood samples collected in EDTA tubes, spun down to plasma and frozen within eight hours of collection – whereby the PAXgene process demonstrated a significantly superior ease of use and robustness. These findings will be presented in a poster at the Association for Molecular Pathology (“AMP”) Annual Meeting to be held in November in Salt Lake City, Utah (Murray D et al, “Effect of blood collection tubes on circulating tumor DNA (ctDNA) yield and specificity”).

Clinical Genomics is the sole U.S. provider of Colvera, a PCR-based assay that detects hypermethylated BCAT1 and IKZF1 DNA in the blood of patients. Colvera has been demonstrated to detect more than twice the number of CRC recurrence cases compared to the current guidelines-recommended blood test. PAXgene technology offers highly integrated and automated solutions for the collection, stabilization and purification of circulating cell-free DNA from blood samples. It allows whole blood to be drawn and stored at cooled and ambient temperatures for up to seven days before samples are processed and tested for the presence of circulating cell-free DNA. Colvera samples in the U.S. will be transported to Clinical Genomics’ laboratory in Bridgewater, New Jersey.  

QIAGEN is a global leader in developing Sample to Insight workflows for non-invasive liquid biopsies in oncology, prenatal testing and other applications. QIAGEN solutions for liquid biopsy sample processing are widely used by pharmaceutical and biotech companies to develop screening tests, diagnostics and companion diagnostics using liquid biopsies and PCR or NGS analysis of biomarkers for stratification or monitoring of patients. In 2015, QIAGEN introduced the first regulated companion diagnostic assay based on molecular biomarkers from circulating tumor DNA. QIAGEN has created a wide range of strong standards for the processing of liquid biopsy samples, including circulating cell free DNA, messenger RNA, circulating tumor cells, exosomes and others. Many of the solutions offer fully integrated and highly automated workflows spanning from collection through to the purified nucleic acid. The QIAGEN solutions are used in numerous diagnostic and research workflows and represent gold standards in terms of performance. Such solutions allow liquid biopsies to be easier and less expensive to perform than tissue biopsies. And they allow for significantly improved sensitivity, specificity and robustness of liquid biopsies which can be reliably repeated at regular intervals for monitoring of disease progression.

*The PAXgene Blood ccfDNA System was developed by PreAnalytiX GmbH, a QIAGEN / BD joint venture company

 

About QIAGEN

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.

About Clinical Genomics

Clinical Genomics is a privately held biotechnology company developing and marketing innovative products for colorectal cancer (CRC) diagnosis. With a broad intellectual property portfolio consisting of more than 95 patents, Clinical Genomics offers colorectal cancer screening and monitoring solutions. In 2016, Clinical Genomics launched Colvera™, a sensitive and specific blood-based circulating tumor DNA (ctDNA) test for colorectal cancer recurrence monitoring that detects methylated DNA from two genes, BCAT1 and IKZF1. Via its wholly-owned subsidiary Enterix Inc., the company offers the user-friendly, patient-preferred colorectal cancer screening InSure® FIT™ assay, an FDA-cleared fecal immunochemical test that detects blood in the stool. Clinical Genomics has offices and a CLIA-registered laboratory in Bridgewater, New Jersey, as well as FDA-registered and TGA-licensed IVD manufacturing facilities in Edison, New Jersey and Sydney, Australia and a NATA-accredited laboratory in North Ryde, NSW Australia. For more information, please visit www.clinicalgenomics.com and www.colveratest.com.

Forward-Looking Statement

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). 

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