HQ Team
August 27, 2024: The US Federal Drug Administration approved Illumina Inc.’s DNA sequencing cancer tests that check more than 500 genes in a tumour to help find targeted therapy options.
The tests are known as TruSight Oncology (TSO) Comprehensive and it is a biomarker test.
It acts as a companion diagnostic to identify adult and pediatric patients with solid tumours who are positive for neurotrophic tyrosine receptor kinase gene fusions that may benefit from treatment with Bayer AG’s Vitrakvi.
A companion diagnostic (Cdx) is a medical device, often an in vitro diagnostic (IVD), which provides information that is essential for the safe and effective use of a corresponding drug or biological product. In vitro is usually performed in test tubes or similar equipment while in vivo tests are performed in the body itself.
Illumina’s TSO Comprehensive device identifies patients who are most likely to benefit from a particular therapeutic product and are likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product.
Non-small Cell Lung Cancer
It can also monitor response to treatment with a particular therapeutic product to adjust treatment to achieve improved safety or effectiveness.
Further, the FDA approved Illumina’s tests to identify adult patients with locally advanced or metastatic rearranged during transfection fusion-positive non-small-cell lung cancer that may benefit from treatment with Eli Lilly’s Retevmo or selpercatinib.
“FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community,” said Everett Cunningham, chief commercial officer of Illumina, headquartered in San Diego, California.
Most companion diagnostic tests are specific to one type of cancer, but Illumina’s is approved for use across solid tumour indications for the neurotrophic tyrosine receptor kinase, helping to maximize the chances of finding “actionable information from each patient’s biopsy,” according to a company statement.
Non-small Cell Lung Cancer (NSCLC) is one of the most common types of lung cancer and the leading cause of cancer-related deaths globally.
Genomic profiling
The expansive actionable biomarker landscape in NSCLC has driven the need for broad molecular profiling to enable a complete view of a patient’s disease to better guide clinical management.
“Through research conducted globally, there is a significant body of evidence demonstrating the clinical utility of comprehensive genomic profiling for patients with advanced cancer,” said Vivek Subbiah, MD, chief, of Early-Phase Drug Development at Sarah Cannon Research Institute.
“Illumina’s newest distributable IVD kit for comprehensive genomic profiling and accompanying CDx enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes.”
The kits will be available in the market this year. Comprehensive genomic profiling assays with CDx claims for solid tumours, like TSO Comprehensive, are reimbursable under a Centers for Medicare & Medicaid Service national coverage determination in the US, according to the statement.
A separate CE-marked version of TSO Comprehensive has been marketed in Europe since 2022.
