Genomadix Cube APOE Testing System (RUO)

“Millions of Americans are living with Alzheimer’s or other dementias (AD). As the size of the U.S. population age 65 and older continues to grow, so too will the number and proportion of Americans with Alzheimer’s or other dementias¹”. “In 2022, an estimated 6.5 million Americans age 65 and older are living with Alzheimer’s dementia and the total national cost of caring for people living with Alzheimer’s and other dementias is projected to reach $321 billion.¹“

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APOE And It’s Role In AD

“Inheritance of the ε4 allele of the Apolipoprotein (APO) E gene is the strongest genetic risk factor for late-onset AD.²“

“Alzheimer’s Disease is the only major cause of death without any effective pharmacological means to treat or slow progression.⁵“

“Apolipoprotein E4 (APOE4), the most prevalent genetic risk factor of AD, is expressed in more than half of AD patients and is thus an important possible AD therapeutic target³.“

“The APOE ε4 allele remains the strongest genetic risk factor for sporadic Alzheimer’s disease … However, no therapies directed at APOE are currently available.⁴“

 

 

 

“AD diagnosis has shifted from syndromal, based on signs and symptoms, to a biomarker construct based on the pathological hallmarks of the disease: amyloid β deposition, pathologic tau, and neurodegeneration.⁵“

“Researchers have long posited that pharmacologic treatments, or medications, aimed at slowing or stopping the progression of Alzheimer’s disease to dementia and preserving brain function are most effective when administered early in the disease process.¹“

“The road to the discovery of effective AD therapies has been marked by a long string of failures, at least in part, due to relatively few investigators directly targeting the critical role of APOE in AD.²“

55.8%

55.8% of Alzheimer’s Disease patients in the US are carriers of APOE E4.⁶

11.5%

11.5% of Alzheimer’s Disease patients are carriers of the APOE E4/E4 in the US.⁶

Promising AD Therapeutic Target

“Despite the enormous amounts of resources and efforts for AD drug development during the last three decades, no effective treatments have been developed that can slow or halt the progression of the disease.” ⁷

“APOE ε4 is a promising AD therapeutic target, that remains understudied. With recent studies are now paving the way for effective APOE ε4-directed AD treatment approaches.”³

 

“In 2022, the total national cost of caring for people living with Alzheimer’s and other dementias is projected to reach $321 billion.”¹

How Genomadix Can Help

  • “Low participation in clinical trials is a major challenge to advancing clinical  AD research and care.”⁸
  • “The success of randomized controlled trials (RCTs) relies on adequate and timely recruitment.”⁸
  • “Pharmacogenomic testing can help doctors decide which medications to use. An individual’s genes may help determine which medications to avoid or how to adjust the dose of a medication allowing a doctor to tailor medications to a patient based on differences in the patient’s genes.“⁹

Reduced Trial Cost

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Alzheimers Facts and Figures 2022

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REFERENCES

  1. Alz.org. 2022. 2022 Alzheimer’s Disease Facts and Figures. [online] Available at: <https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf> [Accessed 27 July 2022]. 
  2. Wisniewski T, Drummond E. APOE-amyloid interaction: Therapeutic targets. Neurobiol Dis. 2020 May;138:104784. doi: 10.1016/j.nbd.2020.104784. Epub 2020 Feb 4. PMID: 32027932; PMCID: PMC7118587.  
  3. Safieh, M., Korczyn, A.D. & Michaelson, D.M. ApoE4: an emerging therapeutic target for Alzheimer’s disease. BMC Med 17, 64 (2019). https://doi.org/10.1186/s12916-019-1299-4  
  4. Serrano-Pozo A, Das S, Hyman BT. APOE and Alzheimer’s disease: advances in genetics, pathophysiology, and therapeutic approaches. Lancet Neurol. 2021 Jan;20(1):68-80. doi: 10.1016/S1474-4422(20)30412-9. Erratum in: Lancet Neurol. 2021 Feb;20(2):e2. PMID: 33340485; PMCID: PMC8096522. 
  5. van Bokhoven, P., de Wilde, A., Vermunt, L. et al. The Alzheimer’s disease drug development landscape. Alz Res Therapy 13, 186 (2021). https://doi.org/10.1186/s13195-021-00927-z  
  6. Ward et al. Prevalence of Apolipoprotein E4 Genotype and Homozygotes (APOE e4/4) among Patients Diagnosed with Alzheimer’s Disease: A Systematic Review and Meta-Analysis Neuroepidemiology 2012;38:1–17 https://doi.org/10.1159/000334607 
  7. Gong CX, Dai CL, Liu F, Iqbal K. Multi-Targets: An Unconventional Drug Development Strategy for Alzheimer’s Disease. Front Aging Neurosci. 2022 Feb 9;14:837649. doi: 10.3389/fnagi.2022.837649. PMID: 35222001; PMCID: PMC8864545. 
  8. Clement C, Selman LE, Kehoe PG, Howden B, Lane JA, Horwood J. Challenges to and Facilitators of Recruitment to an Alzheimer’s Disease Clinical Trial: A Qualitative Interview Study. J Alzheimers Dis. 2019;69(4):1067-1075. doi:10.3233/JAD-190146 
  9. Cleveland Clinic. 2022. Pharmacogenomics. [online] Available at: <https://my.clevelandclinic.org/health/diagnostics/21093-pharmacogenomics> [Accessed 27 July 2022]. 
  10. Belloy ME, Napolioni V, Greicius MD. A Quarter Century of APOE and Alzheimer’s Disease: Progress to Date and the Path Forward. Neuron. 2019 Mar 6;101(5):820-838. doi: 10.1016/j.neuron.2019.01.056. PMID: 30844401; PMCID: PMC6407643. 
  11. Estimate cost of central lab testing in the US market. Data on file at Genomadix. 

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The Genomadix Cube™ APOE System is for research use only (RUO). It is not to be used for the clinical diagnosis of patients.