DeciBio Insights

With the GeneReader Launch, Qiagen Offers a True End-to-End Clinical NGS Solution

Clinical Diagnostics

Austin, TX November 06, 2015 – This past Wednesday, Qiagen announced the launch of its GeneReader NGS system at the Association for Molecular Pathology (AMP) meeting in Austin, TX.

The GeneReader NGS dovetails in other instruments and solutions that Qiagen has been commercializing for quite some time: the QiaCube (automated DNA extraction), the QiaCube NGS (automated library construction), and Qiagen Clinical Insight (clinical decision support). The launch of this platform is in line with the expectation outlined in our NGS report published earlier this week. Just like the S5 / S5 XL before it, the GeneReader platform highlights how NGS instrument manufacturers are increasingly developing clinical solutions differentiated on dimensions beyond the cost / throughput axis. Ease of workflow / “sample-to-insight” solutions can be as important as throughput to clinical lab directors, especially for oncology applications that use small gene panels.

The long awaited system launches along with the Actionable Insights Tumor Panel, a 12-gene cancer panel targeting genes clinically actionable genes selected based on guidelines and favorable reimbursement. The current panel focuses on tumor types of high prevalence and high societal impact: breast cancer, ovarian cancer, colorectal cancer, lung cancer and melanoma. The panel builds on the previously commercialized GeneRead DNAseq V2 panel; it can detect up to 1,250 mutations. While pricing has not been announced, it is expected to be in the $300-400 range.

We talked with Yi Kong, Director of Marketing at the AMP Qiagen booth. She confirmed that the target customers are medium- to low-throughput labs new to sequencing. “We have a small panel, and offer a full sample-to-insight solution” Kong said. “We believe actionability of the results and ease-of-use will enable labs to adopt NGS in-house.”

The company offers 3 pricing models to accommodate labs with various volumes (and based on their preference in different countries):

  • Outright instrument purchase
  • Reagent rentals
  • Pay per insight

Over the last couple of days, we collected feedback from the community from AMP, talking with Qiagen representatives, as well as potential customers showing interest in the platform at the Qiagen AMP booth.

  • “… We don’t have relatively small volumes, so the pay-per-insight solution, which is akin to a reagent rental offering is attractive to me. …” – Potential Customer
  • “… Being able to run flow cells independently is a plus. People have gotten accustom to random access platforms. …” – Potential Customer
  • “… We’re on the market for a sequencer. […] I am trying to keep an open mind, but nowadays it seems like everybody is going with Illumina …” – Potential Customer

Qiagen highlighted the following instrument specifications:

  • Open system (customers can run test they develop on their own)
  • Overall workflow of 4-5 days, from the FFPE sample to the clinical report
  • Only platform with 4 flow cells, giving some random access capability
  • Initial sample extraction: 6.5 hr (including QC), 1 hour hands-on time
  • Multiplexing: 10 samples per flow cell
  • Sequencing run time: 30 hours
  • Throughput: 1 Gb
  • Amplicon size: 134 bp
  • >500x coverage
  • 10 ng of DNA, 330 amplicons
  • Variant frequency cut-off: 5%.
  • Variant insight coverage: 99.8% at >500x and 99.9% at >200x.
  • Coverage of 81 variants in 8 genes that are not covered by Thermo Fisher or Illumina panels (including some established variants).
  • Access to Qiagen knowledge Base, which pulls data from different places (e.g., clinical trials, drug labels, scientific literature, professional guidelines, external databases).
  • Conducted a study with the Broad Institute 3-20 year old samples. Achieved 100% concordance with FDA approved Therascreen assay.
  • Customizable report

Disclaimer: Some of the companies listed in this entry may be DeciBio clients or customers

Authors: Stephane Budel, Partner at DeciBio, LLC
Connect with Stephane Budel on Google+ or Linkedin

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