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First companion diagnostic claim for Illumina’s TruSight™ Oncology Comprehensive (EU) test enables targeted therapy with Bayer’s VITRAKVI® (larotrectinib) for patients with NTRK fusion cancer
SAN DIEGO, May 24, 2022 /PRNewswire/ — Illumina, Inc. (NASDAQ:ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europeassesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer’s VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling.
TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment.
“This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina’s broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine,” said Paula DowdySenior Vice President and General Manager of Illumina for Europethe Middle Eastand Africa. “We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don’t want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy.”
Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient’s biopsy, to inform treatment with larotrectinib.
“Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer,” said Christine RothMember of the Executive …
Full story available on Benzinga.com
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