The FDA has approved Illumina's TruSight Oncology (TSO) Comprehensive IVD test, which incorporates Velsera's advanced tumor profiling technology. This approval marks a significant advancement in cancer diagnostics, promising to enhance personalized treatment strategies for patients across the United States.
The TSO Comprehensive IVD test integrates Velsera's Knowledge Base (KB), a critical component that classifies cancer mutations based on clinical significance. This classification enables healthcare professionals to develop more targeted and effective treatment plans. The collaboration between Velsera and Illumina, which began in December 2018, was driven by a shared goal of improving cancer diagnostics and broadening access to targeted therapeutics.
"Our collaboration with Velsera helped deliver the desired vision in the launch of the TruSight™ Oncology Comprehensive test, which is to provide laboratories with an NGS-based, clinically-optimized in vitro diagnostic (IVD) test that simplifies the identification of important cancer biomarkers," said Nicki Berry, Head of Region-Americas, Illumina.
Velsera's CEO, Jamie Littlejohns, emphasized the company's commitment to advancing cancer diagnostics and making targeted therapeutics more accessible. "Advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide remains our key focus," said Littlejohns. "By working closely with Illumina, we have contributed to making a cutting-edge diagnostic much more accessible and that will now help many more patients with cancer in the US."
This FDA approval signifies a step forward in precision medicine, facilitating faster and more accurate biomarker identification. Velsera and Illumina's collaboration is setting a new standard in the sequencing market, with the ultimate goal of improving patient outcomes through more personalized and effective cancer treatments.
