Illumina Unveils Liquid Biopsy Assay For Genomic Profiling

Illumina Inc., a global pioneer in DNA sequencing and array-based technologies, has announced the availability of a new version of their distributed liquid biopsy test for genomic profiling. The TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) research assay offers noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is unavailable or to supplement tissue-based testing. Key improvements include a faster sample-to-answer turnaround time of less than four days, higher sensitivity with lower cell-free DNA (cfDNA) input requirements, and a more streamlined workflow, which will be further enabled with automation in the first half of 2024, as per pharmabiz. "Leading cancer centres are increasingly adopting the use of liquid-biopsy-based CGP, and with the TSO 500 ctDNA v2 assay we've aimed to make it easier for customers to integrate and enable deeper insights for cancer research," said Kevin Keegan, general manager of oncology at Illumina.

The total turnaround time has been reduced to less than four days. Library preparation has been reduced to a single day, with better chemistry necessitating only a single hybridization step, resulting in a total turnaround time of less than four days. Most ctDNA CGP tests have a one-week or longer turnaround time, but for biomarker data to be the most beneficial, users require insights sooner to better support precision oncology initiatives. Analytically more sensitive test with lower input volumes. The test can analyze cfDNA samples ranging from 5 to 30 nanograms (ng). It has more than 95% analytical sensitivity and 99.9995% specificity at 20 ng input. It has more than 95% sensitivity and 99.9995% specificity for hot-spot mutations at 10 ng input.