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 The test, which Illumina says scans for more mutations than any
available kits, comes amid drug industry efforts to develop
precision oncology drugs for ever smaller patient groups defined by
a genetic profile. This has created pent-up demand for more
sophisticated diagnostic tools.
Illumina's TruSight Oncology Comprehensive test kit scans for 517
cancer-relevant genes across nearly 30 solid tumour types, it said
in a statement.
For instance, it reads out a patient's mutational burden score and
microsatellite instability status, which cancer researchers have
said indicate the need to be given immune drugs such as Merck & Co's
Keytruda.
Also included is the TRK mutation, which is a genetic driver in less
than 1% of cancers and, due to its rarity, often goes untested even
though Bayer's Vitrakvi and Roche's Rozlytrek are available as
approved treatments.
Bayer has said it was struggling to encourage physicians to diagnose
patients that qualify for the niche drug.
"Consolidating all of the critical biomarkers into a single
comprehensive test improves the chances of identifying treatment
options that would otherwise require time-consuming sequential gene
tests from multiple biopsy procedures," Illumina said.
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The launch comes as Illumina is struggling to
win over EU antitrust regulators for its planned
$8 billion bid for Grail Inc, which is working
on blood tests to diagnose early stage cancers.
Illumina said it was preparing to file for U.S.
regulatory approval for the test kit later this
year.
Access to the European medical devices and
diagnostics market is easier because
manufacturers routinely go through a process of
self-certifying that their products function as
stated, without a regulator as gate-keeper.
(Reporting by Ludwig Burger. Editing by Jane
Merriman)
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