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Illumina Expects Pharma Firms to Leverage New Tumor Profiling Panel for Companion Dx


NEW YORK (GenomeWeb) – Illumina anticipates that pharmaceutical companies developing companion diagnostic tests will leverage its TruSight Tumor 170 panel, which will begin shipping to customers in the first quarter of 2017 for research use only.

The new panel leverages a hybrid capture technique that enables both DNA and RNA to be analyzed simultaneously, John Leite, Illumina's VP of oncology, told GenomeWeb.

The TST 170 panel is the second product Illumina has launched as a result of its Actionable Genome Consortium, which it kicked off in 2014 with four academic cancer centers to define what constitutes the actionable cancer genome and to come up with best practices for biopsy, sample storage and transport, and extraction; as well as technical performance standards for DNA sequencing.

As part of that project, Illumina planned to develop products that encompassed those recommendations. It launched its TST 15 panel last year, which uses amplicon sequencing to analyze 15 cancer-related genes. The TST 15 panel is available both as an RUO panel as well as for investigational use. The difference between Illumina's RUO and IUO products is that the IUO products are available only for use in clinical investigation and not commercial sale.

Leite said the TST 170 panel differs in that it uses a hybrid capture technique to analyze both DNA and RNA from the same sample. It requires 40 nanograms each of input RNA and DNA. The cDNA synthesis and DNA shearing steps are performed separately, but then follow the same library prep workflow. Library prep takes 32 hours, followed by a 24-hour sequencing run on the NextSeq instrument or 27-hour sequencing run on the HiSeq 2500. Leite said that cost per sample for TST 170 — which would include both the panel cost and sequencing reagents cost — would run around $625.

Leite said that the TST 170 panel, and in particular, the hybrid capture chemistry that captures and analyzes both DNA and RNA, would be "foundational" to the company's overall strategy in oncology. "We're looking to leverage this as a base for upcoming products," Leite said. "It's a hotbed of activity." He declined to specify what types of products or applications.

Illumina also still plans to launch TST 170 for investigational use, although Leite did not specify when the IUO version would be available. In addition, he anticipated that pharmaceutical companies with which the firm has signed companion diagnostic development agreements would look to use this platform for their tests, which would require a premarket approval application to the US Food and Drug Administration.

In 2014, Illumina signed deals with AstraZeneca, Janssen Biotech, and Sanofi to develop an NGS-based universal companion dx. At the time, the Illumina said it planned to develop the test on the MiSeqDx platform, which has already received FDA 510(k) clearance, although the claims on the platform would need to be updated to reflect its ability to analyze samples from formalin-fixed paraffin-embedded tissue.

Last week, Illumina said that it had submitted a CDx it developed in conjunction with Amgen for its colorectal cancer drug Vectibix to the FDA.

Illumina is not the only firm to recognize the value of simultaneous DNA and RNA analysis, particularly in the oncology field, where sample is limited and RNA analysis to identify gene fusions and expression can add significant value.

Thermo Fisher Scientific has developed an AmpliSeq-based panel that analyzes both DNA and RNA, and has developed a universal CDx in conjunction with Pfizer and Novartis that analyzes both DNA and RNA from around 50 genes, and which it plans to submit to the FDA.