Molecular diagnostics firm Asuragen has collaborated with clinical-stage genetic medicines company Wave Life Sciences to develop companion diagnostics for Huntington’s disease (HD).
As part of the agreement, the partnership will develop and commercialise companion diagnostics for Wave’s investigational allele-selective therapeutic programs targeting HD.
HD is a destructive disorder caused by an expansion of CAG repeats in the HTT gene, which results in the progressive breakdown of nerve cells in the brain.
Wave Life Sciences bioanalytics, pharmacology and biomarker development vice president Dr Jaya Goyal said: “Our partnership with Asuragen for companion diagnostic development was a natural fit in light of their deep knowledge and expertise with challenging molecular targets, diagnostic regulatory experience and their growing presence in the neurogenetics testing market.”
The partnership will use Asuragen’s repetitive sequence diagnostic expertise
Asuragen will develop companion diagnostics based on the experience gained by Wave using a single-nucleotide polymorphism (SNP) phasing methodology in its current clinical studies in HD and a previous observational study.
The partnership intends to use Asuragen’s repetitive sequence diagnostic expertise to offer scalable SNP phasing to support potential global phase 3 development programmes and future commercialisation at a global level.
Asuragen said that its AmplideX PCR technology has revolutionised the analysis of repeat expansions in multiple neurological disorders.
The company will apply the same technology to develop companion diagnostic tests, which size and phase HTT CAG repeats with two different SNPs targeted by Wave’s WVE-120101 and WVE-120102 investigational therapeutic programmes.
Asuragen president and CEO Dr Matthew McManus said: “We’re pleased to be a part of this new category of potential therapies and to have a positive impact on such a devastating disease.
“Developing a companion diagnostic for Wave’s novel allele-selective silencing program in HD is a great example of how our products will continue to advance personalized medicine.”
At present, Wave is carrying out two Phase 1b/2a clinical trials, including Precision-HD1 and Precision-HD2, for patients with HD.
The studies are assessing WVE-120101 and WVE-120102, which are stereopure oligonucleotides designed to reduce the mutant HTT mRNA transcript by targeting one of two SNPs while leaving the wild-type transcript relatively intact.
In December 2018, Asuragen secured CE mark approval for its AmplideX DM1 Dx kit, which is developed to diagnose Myotonic Dystrophy Type I (DM1) or Steinert’s disease.
