Cytox publishes research showing its genoSCORE-LAB test can predict the risk of cognitive decline due to Alzheimer’s disease without invasive procedures
genoSCORE™-LAB a new genetic test to launch in 2020 enables early assessment of patients with cognitive complaints from a simple saliva or blood sample
17th November 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 published new research in the Journal of Prevention of Alzheimer’s Disease (JPAD) (https://rdcu.be/caGKD) on its genetic test, genoSCORETM-LAB to predict the risk of cognitive decline due to Alzheimer’s disease (AD).
The new research shows that the test is comparable to existing amyloid and tau biomarker tests in predicting the risk of cognitive decline. However, genoSCORE-LAB only requires a saliva or blood sample compared with an invasive lumbar puncture, and cerebrospinal fluid (CSF) extraction. Indeed, genoSCORE-LAB’s simplicity of sampling enables elderly and vulnerable patients self-isolating due to COVID-19, or not wishing or easily able to attend healthcare settings, to provide a suitable sample from home.
Furthermore, genoSCORE-LAB provides a more comprehensive analysis of genetic risk for AD, than many current genetic tests. Such existing tests look at an individual’s APOE4 status, a major genetic component of risk in late-onset AD. However, genoSCORE-LAB provides additional information on the genetic risk of cognitive decline due to AD in all individuals, thereby providing a more comprehensive risk stratification tool in both carriers and non-carriers of the APOE4 risk allele.
Clinicians can use genoSCORE-LAB for early assessment of patients with cognitive complaints, gaining insight into their risk of cognitive decline due to AD, prior to invasive CSF testing or expensive scanning procedures. Understanding the risks of cognitive decline can help guide patient lifestyle choices to mitigate the risks of disease progression.
Additionally, developers of new AD drug therapies can use genoSCORE-LAB to identify and recruit patients to clinical studies, ensuring the selection of the most suitable candidates, those most likely to experience cognitive decline over the time period of the study, regardless of APOE status.
Dr. Alex Gibson, Business Development Officer of Cytox, and corresponding author of the paper commented: “The results of these analyses show that our polygenic risk scoring algorithms, which have been designed to understand the genetic risk of future onset of Alzheimer’s disease, avoid the need for invasive procedures in all patients, and can be applied within a recruitment strategy to enrich trial populations with individuals who are more likely to decline cognitively within the time period of the trial. This is a critical factor when developing new drugs, as it increases the ability to observe prevention and delay of cognitive decline through administration of the test drug.”
Dr. Richard Pither, CEO of Cytox, commented: “Globally there are an estimated 10 million new cases of dementia each year, of which at least a half are Alzheimer’s disease. The disease is estimated to cost healthcare systems billions of dollars a year and is rising. We believe that genoSCORE-LAB has a valuable role to play in both the management of new patients, and the development of new drugs to treat the disease.”
Richard Pither, Chief Executive Officer Tel: +44 (0)1865 338 018
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.
Cytox is launching genoSCORE-LAB at the end of 2020 as a CE marked product in Europe and as a Laboratory Developed Test (LDT) in the U.S.. genoSCORE-LAB is a genetic test to predict future risk of cognitive decline due to Alzheimer’s disease (AD). The test, which uses a simple blood or saliva sample, analyses patient genotypes against an array of around 114,000 single nucleotide polymorphisms (SNPs) that have been associated with AD. As such, the test generates a patient-specific polygenic risk score (PRS).
Clinicians can use genoSCORE-LAB to assess patients for the risk of developing Alzheimer's, before symptoms arise, prior to invasive cerebrospinal fluid (CSF) testing or expensive scanning techniques. Furthermore, the test’s simplicity of use would enable elderly and vulnerable patients self-isolating due to COVID-19, or not wishing or easily able to attend healthcare settings, 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 the most suitable candidates, those most likely to experience cognitive decline over the time period of the study.
This test is a measure of relative risk for future onset of Late-onset Alzheimer’s disease (LOAD) and should not be considered as a standalone diagnostic test. A high genoSCORE test result does not indicate that an individual will definitively develop LOAD in the future, and conversely, a low genoSCORE result does not categorically mean that subsequent onset of LOAD will never occur. The test result should be used in conjunction with other information available to the physician.