Illumina Inc, San Diego, has announced the launch of TruSight Tumor 15, a next-generation sequencing (NGS) panel designed to identify sequence variants in 15 genes commonly associated with marketed therapeutics.
“In 2014, Illumina catalyzed the Actionable Genome Consortium (AGC), bringing together thought leaders to define the standards and content for NGS panels intended for use in oncology applications,” says Francis deSouza, president of Illumina. “The TruSight Tumor panel represents the first product, intended for research use only, based on the initial standards defined by the AGC and pharma partners, enabling researchers to advance the application of NGS in this important field.”
The new sequencing panel is optimized for damaged and degraded formalin-fixed, paraffin embedded (FFPE) tumor samples, enabling low frequency somatic variant detection from limited nucleic acid inputs. When paired with the Illumina MiSeq system, the panel delivers high-quality sequencing with key content and features needed for tumor analysis in translational research.
Illumina is committed to collaborating with pharma partners, the Actionable Genome Consortium, regulatory agencies, and key opinion leaders to establish best practices and consensus standards in NGS testing.
“Tumor biopsies are collecting ever smaller amounts of cancer tissue and the fixation and preservation of the material results in degraded DNA. The challenge for scientists has been to get sufficient intact DNA to efficiently identify the key genetic drivers,” says John Leite, PhD, vice president of oncology at Illumina. “This new panel is designed to reduce the resource burden on small- and medium-sized labs by offering a simple, accurate, and fast solution that addresses tissue considerations on the front end and provides streamlined analytics on the back end.”
Jamie Platt, PhD, vice president of genomic solutions at Molecular Pathology Laboratory Network Inc, Maryville, Tenn, evaluated the product in beta testing and said the panel’s simplicity and ease of use makes it well-suited for translational labs. “The value and appeal of next-generation sequencing is the potential to consolidate traditionally iterative tumor analyses,” says Platt. “Our evaluation of the new TruSight Tumor 15, with its streamlined library prep and sequencing workflow, gives us confidence that this application is ideal for deployment. Even our most challenging samples produced results, including those with low nucleic acid inputs, giving us assurance we can analyze our most precious specimens.”
TruSight Tumor 15 offers a sample-to-data solution for research of common somatic variants. The panel’s focused gene content was informed by pharmaceutical partners, an independent consortia of key opinion leaders, and the needs of pharmaceutical clinical researchers to identify relevant somatic variants in common solid tumors.
The panel’s simple sample-to-data workflow is optimized for Illumina’s MiSeq instrument, and improves lab operational efficiency by replacing the cost- and resource-intensive practice of iterative single-gene analysis. The test’s streamlined multiplex PCR-based library prep method, with limited hands on time, produces high-quality data in approximately 36 hours from extracted DNA to result. The assay detects somatic mutations at 5% variant frequency and maximizes sample success with just 20 ng of DNA isolated from FFPE samples.
According to the company, TruSight Tumor 15 is available for order and will begin shipping during the final quarter of 2015. For more information, visit Illumina.