Cytox appoints Yourgene Genomic Services as European partner
Partnership will enable clinical access to genoSCORE™ - a new genetic test to determine the risk of developing Alzheimer’s disease
21st October 2020: Oxford and Manchester, UK. Cytox Ltd, which provides non-invasive, risk assessment and patient stratification tools for Alzheimer's disease (AD) and dementia, has appointed Yourgene Health (AIM: YGEN), a leading international molecular diagnostics group, specifically its Yourgene Genomic Services (YGS), as its Beta testing clinical laboratory partner for genoSCORE-LAB.
Cytox is launching genoSCORE-LAB at the end of 2020 as a CE marked product in Europe (progress on a Laboratory Developed Test (LDT) for the U.S. market will follow in due course). genoSCORE-LAB is a new genetic test to predict future risk of developing AD and associated cognitive decline. The test, which uses a simple blood or saliva sample, analyses patient genotypes against an array of about 114,000 single nucleotide polymorphisms (SNPs) that have been associated with AD. As such, the test generates a patient-specific polygenic risk score (PRS).
Initially, under the partnership, YGS will validate and verify the performance of the Cytox genoSCORE-LAB1 process and test for both whole blood and saliva samples, to ensure the robust and reproducible detection of genotypes necessary to calculate individual polygenic risk scoring (“PRS”).
Patient-facing clinicians can use genoSCORE-LAB to assess patients for the risk of developing Alzheimer's, before symptoms arise, prior to invasive cerebrospinal fluid testing or expensive scanning techniques. Furthermore, the test’s simplicity of use would enable elderly and vulnerable patients, self-isolating or not wishing to attend healthcare settings due to Covid-19, to provide a suitable sample from home.
Developers of new AD drug therapies can also use genoSCORE-LAB to identify and recruit patients to clinical studies, ensuring the selection of relevant patients, those most likely to experience near-term disease progression.
Dr. Richard Pither, CEO of Cytox, commented: “In Europe there are an estimated 1.6milion new cases of dementia each year, of which 800,000 are Alzheimer’s disease. As part of the disease management pathway, we anticipate clinicians adopting genoSCORE-LAB as an early test for new AD patients, but also to provide additional insight into existing patients.. We look forward to working with the Yourgene team on this initial Beta testing study ahead of our product launch.”
Lyn Rees, CEO of Yourgene Health plc, commented: “This is an exciting partnership for Yourgene Genomic Services and a fine example of our ever increasing product and service offering. We already have a well established relationship with Cytox and are looking forward to working with them on this progressive technology. We hope this will be a long and fruitful partnership for Yourgene Genomic Services and Cytox.”
Richard Pither, Chief Executive Officer Tel: +44 (0)1865 338 018
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About Cytox (www.cytoxgroup.com)
Without new drug therapies, the economic and healthcare cost burden of dementia - including Alzheimer's disease (AD) - is estimated to exceed $1tn per year in the next decade1. AD – a highly complex disease with risk factors based in genetics, lifestyle, age, and environment – has seen no new approved drug therapy since 2003; and clinical trial failure rates run at 99.6%. Cytox’s products genoSCORETM and genoTORTM use Polygenic Risk Scoring (PRS) to predict the risk of individuals developing AD, and to improve clinical trial outcomes through patient stratification and the genetic characterisation of the disease.
1. World Alzheimer’s Report 2015 www.alz.co.uk/research/WorldAlzheimerReport2015.pdf
About Yourgene Health
Yourgene Health is an international molecular diagnostics group which develops and commercialises genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Yourgene develops and commercialises simple and accurate molecular diagnostic solutions, for reproductive health and precision medicine. The Group’s products include non-invasive prenatal tests (NIPT) for Down’s Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, male infertility tests and genetic disease tests. Yourgene’s commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia.
Our product development, research service and commercial capabilities extend across the lifecycle of genetic test development including regulatory submissions. Through our technical expertise and partnerships, Yourgene Health is also extending its genetic testing offering into oncology.
Yourgene Health is headquartered in Manchester, UK with offices in Taipei and Singapore, and is listed on the London Stock Exchange's AIM market under the ticker "YGEN". For more information visit www.yourgene-health.com and follow us on twitter @Yourgene_Health.