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Jun 8, 2021
Cytox welcomes FDA’s approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease
Cytox genoSCORE-LAB test can identify patients most at risk of cognitive decline, and potentially most likely to benefit from new drug
8th June 2021: Oxford and Manchester, UK. Cytox Ltd, which provides non-invasive, risk assessment and patient stratification tools for Alzheimer's disease (AD) and dementia, welcomes the decision from the US FDA to approve Biogen’s Aduhelm (aducanumab) to treat early-stages of AD using its Accelerated Approval pathway.
According to the FDA statement on the approval1: “This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”
Dr. Richard Pither, CEO of Cytox, commented:“As a member of the community seeking to accelerate new treatments for Alzheimer’s disease reaching patients, we are delighted with the FDA decision to approve Biogen’s Aduhelm.
Our new test, genoSCORE-LAB, is designed to identify individuals most at risk of cognitive decline due to Alzheimer’s disease. As a genetic test it shows an individual’s risk decades before any symptoms arise and is suitable for use in adults over 18 years of age.
As Aduhelm has maximal efficacy in the early stages of AD, it has never been more important to understand your risk of AD and to seek early interventions, be these lifestyle changes or drug interventions.
Additionally, we believe this first approval will boost investment into Alzheimer’s R&D, and the number of new drug candidates entering clinical studies.
The use of genoSCORE-LAB during the patient recruitment phase of clinical studies, enables the selection of those individuals most likely to experience cognitive decline over the period of the study. With cohorts of patients enriched in this manner, it increases the probability of observing efficacy with investigational new drugs.”
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 decade2. 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.
genoSCORE-LAB is a new non-invasive test that can predict the risk of an individual developing Alzheimer’s disease from a simple saliva sample.
Cytox launched genoSCORE-LAB at the end of 2020 as a CE marked product in Europe and is preparing to launch an equivalent 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 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.