Cutting edge approaches which use techniques such as liquid biopsy are the future of biomarker testing, but require expertise and leadership to develop.
QIAGEN’s companion diagnostic assays are designed to ease the challenges faced by pathologists in labs performing the tests. By engaging with stakeholders, such as laboratorians and oncologists, QIAGEN’s diagnostic assays aim to deliver multiple benefits to meet market demands, such as:
- -fast turnaround time
- -high accuracy and sensitivity
- -robustness and consistency
- -ability to meet global regulatory requirements
QIAGEN helps develop breakthroughs such as new cutting edge biomarker strategies into everyday benefits, and leverages innovations across the continuum from basic research to routine healthcare. Biomarker detection from liquid biopsy is an example of a novel strategy, which has the potential to expand biomarker testing opportunities. Here we review liquid biopsy as a novel approach for biomarker testing, and discuss how QIAGEN aims to support this trend in biomarker detection, which has potential for new oncology companion diagnostic test development.
A common challenge in biomarker testing of solid tumors, such as those associated with lung cancers, is obtaining sufficient biopsy material to perform biomarker testing. Either there is not enough biopsy to perform all required biomarker tests, or the tumor is not accessible for biopsy (1). The analysis of tumor-derived circulating cell-free DNA (ctDNA) in plasma is a noninvasive method for detecting genetic alterations in tumors, and holds promise in the clinic for improving biomarker testing for patient diagnosis and monitoring. In fact, the use of liquid biopsy to isolate ctDNA was announced by Cleveland Clinic as one of the top 10 medical innovations of 2017 (6). QIAGEN’s therascreen_EGFR_Plasma_RGQ_PCR_Kit, available for IVD use in Europe, was the first commercially available circulating cell-free DNA (cfDNA) assay for CE-IVD use (2), and was recently used to confirm that ctDNA is feasible for EGFR mutation analysis (3; read review article here). To make biomarker testing from liquid biopsy more feasible, pre-analytical methods must be optimized and standardized to ensure quality cfDNA sample recovery for successful mutation detection (5). Find out more about how pre-analysis of cfDNA can be optimized.
Teams at QIAGEN attended an event on ‘Liquid Biopsies in Oncology Drug and Device Development’, co-sponsored by the Food and Drug Administration (FDA) and American Association for Cancer Research (AACR) (4), which fostered conversation among the top thought leaders on the topic of liquid biopsy. Information shared in workshops like these provide a rich foundation of information leveraged by QIAGEN’s teams for determining liquid biopsy test development strategies to meet market needs. Several liquid biopsy solutions are available from QIAGEN, which can be used for biomarker test development using cfDNA samples. Aside from QIAGEN’s therascreen EGFR Plasma assay (available in Europe for IVD use), QIAGEN also offers an entire workflow_of_solutions for biomarker research and enables robust plasma collection, cfDNA isolation from plasma, as well as biomarker mutation detection and analysis from cfDNA samples. QIAGEN’s recent launch of its PAXgene_Blood_ccfDNA_Tubes ** supports the need for a standardized pre-analytical method of blood collection that stabilizes cfDNA and prevents hemolysis. The PAXgene ccfDNA tubes contain a unique non-crosslinking reagent that ensures cfDNA levels are preserved during collection and transport. They contribute to a fully integrated, complete and standardized system, covering pre-analytical workflow steps from blood collection, stabilization, transport, storage and isolation of high quality cfDNA, and are a great addition to QIAGEN’s broad portfolio of liquid biopsy solutions. The QIAamp_Circulating_Nucleic_Acid_Kit * is considered the gold standard sample technology in manual extraction of cfDNA (2) and was recently successfully used for ctDNA sample preparation in a large, global study analyzing the feasibility of using ctDNA for patient testing (3; see review article here). QIAGEN is in the process of finalizing development of a fully automated IVD kit for use in Europe, to enable extraction of cfDNA on the QIAsymphony, which will make sample preparation even quicker and easier. The kit brings significant improvements in extraction chemistry to enhance processing of large sample volumes (e.g., 4 ml plasma) and to increase throughput on the QIAsymphony SP instrument. This new kit is planned to launch in early 2017.
As further evidence of QIAGEN’s investment in developing liquid biopsy technologies, the company introduced in June a liquid_biopsy_workflow for the QIAact_Tumor_Panels** on the GeneReader system, which enables detection of a broad range of biomarkers in clinical research to add valuable insights about the progression of the most common cancers. For research labs focusing on new biomarker discovery using llumina or Ion Torrent sequencers, the QIAseq_cfDNA_All-in-One_Kit* uniquely combines cfDNA extraction from plasma with NGS library preparation in a way that avoids sample loss while ensuring optimal sample conversion at every step. Find_out about how labs are using QIAGEN’s liquid biopsy solutions in a Gene Reader ** workflow for analyzing cfDNA.
QIAGEN’s mission is to enable partners to achieve outstanding success and breakthroughs that make improvements in life possible. QIAGEN achieves this by closely following evolving market requirements, listening to the needs of the customer, and nurturing partner relationships to drive innovation and leadership. Their growing portfolio of liquid biopsy solutions is just one example of QIAGEN’s market-driven innovation. Keep an eye out for a related upcoming article in preparation, which reveals how QIAGEN’s biomarker development strategy includes multiple next-generation sequencing (NGS) solutions!
* The QIAamp Circulating Nucleic Acid Kit and the QIAseq cfDNA All-in-One Kit are intended for molecular biology applications. These products are not intended for the diagnosis, prevention, or treatment of a disease.
** The PAXgene Blood ccfDNA Tubes, QIAact Tumor Panels and the Gene Reader are for research use only (RUO).
- 1. FDA-AACR: Liquid Biopsies in Oncology Drug and Device Development. Transcript from Session 3 of the Panel Discussion held during the workshop. Link
- 2. Press release, January 12, 2015. QIAGEN Announces First-ever Regulatory Registration of a Lung Cancer Companion Diagnostic Based on Liquid Biopsies. Link
- 3. Reck, M., et al. (2016) ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study. J Thorac Oncol 11:1682–1689. Link
- 4. FDA-AACR: Liquid Biopsies in Oncology Drug and Device Development. Slide/audio recordings and transcripts from the workshop held July 19, 2016 at the Walter E. Washington Convention Center, Washington, D.C. Link
- 5. Sherwood, J.L., et al. (2016) Optimised Pre-Analytical Methods Improve KRAS Mutation Detection in Circulating Tumour DNA (ctDNA) from Patients with Non-Small Cell Lung Cancer (NSCLC). PLOS ONE 11(2):e0150197. Link
- 6. Press release, Cleveland Clinic, October 26, 2016. ‘Cleveland Clinic Unveils Top 10 Medical Innovations Most Likley To Be Game Changers’. Link