QIAGEN Bolsters Presence in Clinical NGS and Cancer Diagnostics Markets with GeneReader System Launch

QIAGEN Bolsters Presence in Clinical NGS and Cancer Diagnostics Markets with GeneReader System Launch

Kalorama Information provides further analysis of QIAGEN and its competitors, including the companies’ cancer diagnostics and NGS product portfolios, in recent market research reportsThe World Market for Cancer Diagnostics, 6th Edition; Library Preparation and Target Enrichment for Next Generation Sequencing Product Markets; andNext Generation Sequencing Markets.

Several years of technology acquisition and internal development have culminated for QIAGEN with the launch of its comprehensive next-generation sequencing (NGS) workflow, the GeneReader system. The research and clinical NGS solution will expand QIAGEN’s market opportunity in NGS markets with product sales from sample preparation through automated interpretation of clinical sequencing results. Currently, Kalorama Information ranks QIAGEN behind Illumina, Agilent, Thermo Fisher and Fluidigm in market share for NGS library prep and target enrichment. Likewise, QIAGEN has held a relative secondary market share in the overall sequencing market. However, QIAGEN’s position in NGS markets is set to rise substantially, particularly as it more thoroughly addresses the market for sequencing assays in clinical oncology - a market space expected by Kalorama Information to grow at a substantially higher annual rate than the overall cancer diagnostics market through 2019.

QIAGEN is already highly visible within the molecular cancer diagnostics market through its FDA-approved therascreen Rotor-Gene Q (RGQ) PCR kits for EGFR and KRAS variant testing as well as its CE-marked and internationally available PCR and pyrosequencing assays for various oncogene variants. These and other products have also contributed to QIAGEN leadership in oncology-related companion diagnostics.

In next-generation sequencing, QIAGEN has proceeded arguably in a reverse manner to its competitors. The company has been a leader in sample preparation, including nucleic acid extraction and purification, for years. Acquisitions of CLC bio and Ingenuity systems expanded QIAGEN’s presence in bioinformatics at the output end of sequencing workflows. The build-out of QIAGEN’s NGS product portfolio was preceded by the acquisition of Biotage’s Pyromark instrument family in 2008 - a distant event in the accelerated timeline of NGS innovation. Other many leading NGS players such as Illumina developed with a sequencer instrument at their center.

With the launch of its GeneReader system, QIAGEN will be able to touch all the bases in NGS. Complementing the unveiled GeneReader instrument, QIAGEN offers open-platform sample solutions for tissue (GeneRead DNA FFPE Kit); single cells (REPLI-g WTA Single Cell Kits; potential application with CTCs); and exosomes (developed with Exosome Diagnostics). DNASeq v2.0 panels perform PCR-based target enrichment of oncogenes for sequencing on any platform. QIAGEN’s QiaCube performs automated extraction and library preparation; library amplification is additionally performed on the GeneRead QiaCube. Sequencing data analysis and informatics solutions from QIAGEN - represented respectively by Ingenuity data analysis and CLC clinical data interpretation products - are also compatible with third-party sequencer platforms.

This week’s GeneReader instrument launch was accompanied by a presentation of head-to-head results of the sequencer’s Actionable Insights Tumor Panel compared to QIAGEN therascreen PCR and pyrosequencing assays and Illumina’s MiSeq Sequencer. Data results from the GeneReader panel were 100% in agreement with results from the therascreen assays and Illumina sequencer. However, the presentation critically noted that QIAGEN’s workflow provided a comparatively “more accurate reflection of genuine somatic mutations” present in the FFPE tumor samples by mitigating the effects of FFPE artifacts. The QIAGEN GeneReader system also detected additional target sequence aberrations compared to therascreen products. With these demonstrated analytical strengths, the GeneReader system will effectively complement QIAGEN’s existing portfolio of NGS and cancer sequencing products. Competitors such as Illumina are already working to counter QIAGEN’s pronounced strength in Europe or the second-leading regional market for NGS products and cancer diagnostics.

Additional market insights, including market segmentation by product, region and competitor share, are available with Kalorama Information market research reports The World Market for Cancer Diagnostics, 6th Edition; Library Preparation and Target Enrichment for Next Generation Sequencing Product Markets; and Next Generation Sequencing Markets.