The TSO 500 pan-cancer assay, which is the newest addition to the Illumina oncology portfolio, is designed to identify known and emerging tumor biomarkers.

It offers researchers the ability to measure tumor mutational burden (TMB) and microsatellite instability.

Illumina said the pan-cancer assay is for research use only and will be shipped in the first quarter of 2019.

TruSight Oncology 500 uses both DNA and RNA from subject tumor samples to find key somatic variants underlying tumor progression, such as small DNA variants, fusions, and splice variants.

Illumina said the pan-cancer assay offers deep, adaptable, and accessible sequencing power.

The company added that the deep investigational power of TSO 500 covers several genes, alterations that are being utilized to identify patients for clinical trials, while covering 1.94Mb of the genome to measure TMB.

Illumina clinical genomics executive vice president Garret Hampton said: “By focusing on our most differentiated oncology products, we can meet the needs of our customers and provide a comprehensive NGS panel that includes all of the known and anticipated biomarkers associated with targeted and immune-based therapies.

“As we move to bring a future in vitro diagnostic version through regulatory approval, we will be able to set the standard for accurate and reproducible testing. Today’s value in the capability to call for TMB is in line with current research and emerging guidelines, but the promise that TruSight Oncology 500 holds for the future identification of biomarkers, makes it a robust solution for this rapidly evolving field.”

As per the company, the assay unlocks immunotherapy research with rigorously developed and accurate TMB and MSI algorithms, with a dedicated tumor-only workflow.

It also offers the flexibility to identify a vast majority of known genetic variants, whether it be small variants, gene amplifications, de novo fusions, or splice variants.

The ability to run RNA and DNA biomarkers into one workflow allows a lab to assess all appropriate biomarkers at the same time.