Almac validates novel gene biomarker test for Ovarian Cancer
5 June 2014
Almac Group’s Diagnostics Business Unit has announced the
validated results of the ALM AADx assay, a gene expression test that
identifies a subgroup of high grade serous ovarian cancer (HGSOC)
patients that have a good prognosis following standard of care
Significantly this good prognosis subgroup exhibited worse
progression free survival and overall survival following the
addition of bevacizumab within the ICON7 translational dataset.
Patients whose tumours fell outside of this molecular subgroup
exhibited a trend towards improved progression free survival
The molecular subgroup identified by this test is defined by
absence of angiogenesis and represents 40% of the HGSOC population.
The molecular subgroup was identified by Almac in collaboration with
Professor Charlie Gourley from the University of Edinburgh and was
initially reported at ASCO 2011. The current work represents an
independent validation of the assay and was carried out in
collaboration with the Medical Research Council in the UK.
Unsupervised hierarchical clustering by Almac found three
molecular subgroups within HGSOC; one with angiogenic gene
inactivation and immune gene upregulation (‘termed the immune’
subgroup) with better overall survival rates; and two with
angiogenic gene upregulation and a corresponding worse overall
survival rate following standard of care first line chemotherapy.
These latest validation results were presented at the 2014 ASCO
Annual Meeting in Chicago by Professor Gourley.
Almac developed a 63-gene test that can prospectively identify
the good prognosis angiogenesis inactive subgroup and independently
validated the test within the ICON7 translational data set.
Almac is now seeking to perform additional validation studies of
the test in HGSOC as well as in other cancer types. Almac believes
that the test will also work for other anti-angiogenic compounds
that function in a similar manner as well as for other diseases and
has now engaged with the FDA & European Regulatory Authorities to
bring this novel assay to market in 2015.
Prof Richard Kennedy, Almac & Queen’s University Belfast, stated,
“This assay may help clinicians discuss the likely benefit from
standard carboplatin and paclitaxel based chemotherapy with their
patients and could inform discussions on other potential approaches
to treatment for those with a predicted worse outcome”