Genome sequencing group Illumina on Tuesday launched a cancer test in Europe that checks for a wide range of tumor genes in a tissue sample, potentially helping patients with rare diseases be matched with options treatment.
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Genome sequencing group Illumina on Tuesday launched a cancer test in Europe that checks for a wide range of tumor genes in a tissue sample, potentially helping patients with rare diseases be matched with options treatment.
The test, which Illumina says looks for more mutations than any kit available, comes amid efforts by the pharmaceutical industry to develop precision oncology drugs for ever-smaller groups of patients defined by genetic profiling. . This created a pent-up demand for more sophisticated diagnostic tools.
Illumina’s TruSight Oncology Comprehensive test kit looks for 517 cancer-relevant genes in nearly 30 solid tumor types, it said in a statement.
For example, it reads a patient’s mutational load score and microsatellite instability status, which cancer researchers believe indicates the need for immune drugs such as Merck & Co’s Keytruda.
Also included is the TRK mutation, which is a genetic factor in less than 1% of cancers and, due to its rarity, is often not tested even though Vitrakvi from Bayer and Rozlytrek from Roche are available as approved treatments.
Bayer said it struggled to encourage doctors to diagnose patients eligible for the niche drug.
“Consolidating all critical biomarkers into one comprehensive test improves the odds of identifying treatment options that would otherwise require time-consuming sequential genetic testing from multiple biopsy procedures,” Illumina said.
The launch comes as Illumina struggles to win over EU antitrust regulators for its planned $8 billion bid for Grail Inc, which works on blood tests to diagnose early-stage cancers.
Illumina said it is preparing to file for US regulatory approval for the test kit later this year.
Access to the European medical device and diagnostics market is easier as manufacturers routinely go through a process of self-certifying that their products work as claimed, without a regulatory body acting as a gatekeeper.
(Source: Reuters)
