Illumina launches cancer profiling diagnostic in Europe

The DNA sequencing giant Illumina has launched a new in vitro diagnostic test in Europe designed to profile various cancer mutations and help direct patients to targeted therapies.

Built off of its previous tumor biopsy assays reserved for use by research scientists, the new TruSight Oncology Comprehensive test kit examines multiple cancer genes and biomarkers found in guidelines from the European Society for Medical Oncology, current drug labels and available clinical trials to help connect people with potentially beneficial treatment options.

Those include 517 cancer-relevant genes in DNA and RNA spanning nearly 30 solid tumor types, combined with other genomic signatures such as microsatellite instability and tumor mutational burden. According to Illumina, the one test eliminates the need for clinicians to run sequential gene assays on multiple tissue biopsy samples. 

"Clinicians are increasingly matching the genetics of a patient's cancer with their therapy," Illumina’s chief medical officer, Phil Febbo, said in a statement.

"When a medical center internalizes comprehensive genomic profiling of cancer, the multidisciplinary team includes a molecular pathologist who has more control over the biopsy sample and data generated and can increase the number of informed cases they are able to deliver,” Febbo said. “Evidence suggests when this happens, more patients have access to [comprehensive genomic profiling] and precision medicine earlier on in their disease journey."

The CE-marked diagnostic kit, designed for the NextSeq 550Dx instrument, aims to deliver a turnaround time of four to five days, according to the company. 

Illumina is also developing specific companion diagnostic uses under partnerships with biopharma companies—streamlining the process for finding out if a patient will benefit from a particular cancer drug or if they should be enrolled in a clinical trial—which will be added to the TruSight Oncology Comprehensive test after obtaining subsequent regulatory approvals.

Separately, this week Illumina’s Singapore subsidiary announced a four-year partnership with Trivitron Healthcare to develop next-generation sequencing-based diagnostic tests in India, spanning cancer, infectious diseases, prenatal screening and more. 

The two companies plan to distribute multiple commercial genomic assays that will be manufactured and marketed by the Chennai-based Trivitron following regulatory approvals in the country.