Nonacus introduces its first ultrasensitive qPCR assay for ESR1 mutation detection
31 October 2024, Birmingham UK - Precision genomics company, Nonacus Ltd, has launched GALEASTM uPCR ESR1, an ultrasensitive qPCR (uPCR) assay developed to detect eleven mutations in the ESR1 gene which are known to be associated with resistance to endocrine therapy1.
Endocrine therapy is the main therapeutic option for estrogen receptor-positive (ER+), HER2 negative (HER2-) breast cancers, which account for around 80% of all breast cancers. However, around 40% of ER+ HER2- tumors (which equates to hundreds of thousands of patients in Europe every year) will develop mutations in the ESR1 gene as the cancer progresses1. These mutations are associated with resistance to treatment and poorer outcomes.
With new therapeutic options, like OrserduTM (elacestrant) from Menarini, being approved to treat patients with ESR1 mutations, the importance of monitoring of ESR1 mutations during treatment is being recognised. However current methods for detection tend to deploy either next generation sequencing (NGS) or digital PCR (dPCR) methods, both of which require specialist, often expensive equipment and have longer more complex workflows.
The GALEAS uPCR ESR1 assay is a simple, affordable qPCR-based assay, developed for laboratories studying the role of ESR1 mutations in resistance to hormone therapy treatment.
‘The introduction of GALEAS uPCR: ESR1 assay marks another milestone in our mission to see a world where non-invasive cancer testing is available to everyone’ said Jeff Bousfield, CEO of Nonacus. ‘It delivers an affordable liquid biopsy assay that can be run on a piece of equipment found in almost every genomics lab in the world, opening the capability of ESR1 mutation detection to anyone, anywhere across the globe’.
‘When we started developing our ultrasensitive PCR technology, we could see its potential for use in longitudinal monitoring where detection of changes in tumor DNA using liquid biopsies (a blood test) requires a simple, affordable and scalable technique as well as one that’s extremely sensitive’ said Michael Parks, Director of R&D at Nonacus. ‘The assay we are launching today delivers on all four counts.’
uPCR is a novel method developed by Nonacus which increases the sensitivity and specificity of mutation detection for qPCR but does not require investment in specialist equipment offering laboratories an accessible and affordable method for detecting variants in this important gene.
‘Customers have been asking us for an ESR1 assay for a while’ said Chris Sales, Co-founder and Chief Commercial Officer at Nonacus. ‘With the ESMO and ASCO guidelines recommending ESR1 testing alongside aromatise inhibitor treatment, detecting ESR1 mutations has become increasingly important for clinicians and scientists. We are delighted to be able to offer our customers an assay that combines the sensitivity they need with the simplicity of a qPCR assay’
GALEAS uPCR: ESR1 is for research use only and is available now. For more information, please visit www.nonacus.com
