ClarifyBio
CLEANSE. RESTORE. RENEW.
Potential biomarkers for Clari
| Indication | Biomarker | Commercial suppliers |
|---|---|---|
| Alzheimer’s Disease |
|
IL6 is a standard laboratory measurement. Research-use biomarkers exist for the others (see Table 2) |
| Parkinson’s Disease |
|
Standard laboratory measurements |
| SLE and other IMIDs |
|
Standard laboratory measurements |
| Fertility |
|
PFAS: Eurofins’ forensics team Microplastics: Blueprint (commercial launch TBA) Others via standard laboratory measurements |
| Detoxification |
|
PFASs: Eurofins’ forensics team Microplastics: Blueprint (commercial launch TBA) Mycotoxins and glyphosate: Mosaic Diagnostics EnviroTOX |
| Wellness |
|
Biological age clocks: GlycanAge, Elysium, EpiAge, TruAge etc ‘Omics: most are for research use (see Table 2), with the exception of Nightingale Health’s metabolic platform 33 |
| PASC, PTLDS |
|
Standard laboratory measurements |
| GLP-1 agonist co-treatment |
|
Eurofins |
omics biomarker companies
| Company | Under l y i ng technology | Panels | Selected potential indications |
|---|---|---|---|
| Alamar | Proteomics via multiplexed aptamer binding | Inflammation and CNS panels (250 and 120 proteins, respectively)* | AD, PD, TBI |
| SomaLogic | Proteomics via multiplexed aptamer binding | 11,000-protein panel, as well as inflammation and CNS panels | Organ-specific age |
| O-Link | Proteomics via multiplexed antibody binding | Inflammation and CNS panels | Longevity34, AD35 |
| Nightingale Health (also commerciall y available) | Metabolomics via NMR spectroscopy | Cholesterol, fatty acids, amino acids, etc | Multi-disease36, Longevity33 |
CLARI
Clari Approved Indication (CE Mark): For adjunct use in any condition that requires a reduction of inflammatory cytokines or metabolic waste products, drug overdose and poisonings; can also be used when acute hemodialysis, apheresis, or therapeutic plasma exchange (TPE) is prescribed by a physician.
KEY CLARI BENEFITS
Premium Materials
Patented multimedia blend with 200,000 m2 surface area to maximize adsorption capacity
Non-ionic materials do not impact patient electrolyte balance or cause anaphylactic reactions
Direct plama procedure is safe, fast and easy
Avoids hemolysis risk and inflammatory consequences
Shorter procedures minimize patient risk and cost of care
Compatible with existing plasma separation devices
Broad regulatory approvals
FDA Emergency Use Authorization (EUA) for COVID
Broad CE Mark indication covers removal of cytokines and metabolic waste, drug overdose and poisonings
COLUMN COMPARISON
| COLUMN |
Clari (Marker) |
Cytosorb (Cytosorbents) |
Seraph 100 (ExThera) |
Oxiris (Baxter) |
INUSpheresis |
Therapeutic Plasma Exchange |
|---|---|---|---|---|---|---|
|
Physical characteristics |
||||||
|
Surface area Removal method Multiple adsorption media Non-ionic materials |
200,000 m² Adsorption ✔ ✔ |
40,000 m² Adsorption ✘ ✘ |
40,000 m² (a) Chemical Binding Heparin coated beads ✘ |
1.5 m² Filtration Coated Fiber Filter ✘ |
Unknown Filtration Double Membrane Filters ✘ |
N/A N/A N/A N/A |
|
Procedure |
||||||
|
Exposure to plasma directly (vs. whole blood) Hours per procedure Columns per procedure No Donor Plasma required |
✔ 2 1 ✘ |
✘ 12 – 24 2 – 4+ ✘ |
✘ 12 – 96 1 – 4+ ✘ |
✘ 24 – 96 1 – 4+ ✘ |
✘ 2 – 3 2+ ✘ |
N/A 2 – 4 N/A ✘ |
|
Substances removed |
||||||
|
Cytokines Microplastics Forever chemicals Herbicides, pesticides Overdose drugs |
✔ ✔ ✔ ✔ ✔ |
✔ ✘ ✘ Unknown Unknown |
✘ ✘ ✘ ✘ ✘ |
✔ ✘ ✘ Unknown Unknown |
✔ Unknown Unknown Unknown Unknown |
Partial Partial Partial Partial Partial |
Microplastics
Microplastics can enter our bodies through food, water, and air, and aren’t easily broken down. Once inside, they can trigger inflammation, disrupt hormones, and may carry toxic chemicals that increase the risk of cancer, organ damage, and immune system issues. Over time, the accumulation of microplastics may pose serious, long-term health risks.
- Zhang, C. et al. Association of mixed exposure to microplastics with sperm dysfunction: a multi-site study in China. EBioMedicine 108, 105369 (2024).
- Marfella, R. et al. Microplastics and Nanoplastics in Atheromas and Cardiovascular Events. New England Journal of Medicine 390, 900–910 (2024).
- Kwon, J.-H. et al. Microplastics in Food: A Review on Analytical Methods and Challenges. Int J Environ Res Public Health 17, 6710 (2020).
- Wright, S. L., Ulke, J., Font, A., Chan, K. L. A. & Kelly, F. J. Atmospheric microplastic deposition in an urban environment and an evaluation of transport. Environ Int 136, 105411 (2020).
- Periyasamy, A. P. & Tehrani-Bagha, A. A review on microplastic emission from textile materials and its reduction techniques. Polym Degrad Stab 199, 109901 (2022).
- Campen, M. et al. Bioaccumulation of Microplastics in Decedent Human Brains Assessed by Pyrolysis Gas Chromatography-Mass Spectrometry. Res Sq (2024) doi:10.21203/ rs.3.rs-4345687/v1.
- Hu, C. J. et al. Microplastic presence in dog and human testis and its potential association with sperm count and weights of testis and epididymis. Toxicol Sci 200, 235–240 (2024).
- Winiarska, E., Jutel, M. & Zemelka-Wiacek, M. The potential impact of nano- and microplastics on human health: Understanding human health risks. Environ Res 251, 118535 (2024).
Forever Chemicals
Forever chemicals, or PFAS (per- and polyfluoroalkyl substances), are harmful because they don’t break down quickly in the environment or our bodies, leading to accumulation over time. Linked to cancer, immune system issues, and hormone disruption, they may pose serious long-term health risks.
- D’Ambro, E. L., Murphy, B. N., Bash, J. O., Gilliam, R. C. & Pye, H. O. T. Predictions of PFAS regional-scale atmospheric deposition and ambient air exposure. Science of The Total Environment 902, 166256 (2023).
- Piva, E. et al. Per- and polyfluoroalkyl substances (PFAS) presence in food: Comparison among fresh, frozen and ready-to-eat vegetables. Food Chem 410, 135415 (2023).
- Ragnarsdóttir, O., Abdallah, M. A.-E. & Harrad, S. Dermal uptake: An important pathway of human exposure to perfluoroalkyl substances? Environmental Pollution 307, 119478 (2022).
- Fenton, S. E. et al. Per- and Polyfluoroalkyl Substance Toxicity and Human Health Review: Current State of Knowledge and Strategies for Informing Future Research. Environ Toxicol Chem 40, 606–630 (2021).
- European Environment Agency. Risks of PFAS for human health in Europe (Signal). https://www.eea.europa.eu/en/european-zero-pollution-dashboards/indicators/risk-of-pfas-in-humans (2024).
- Gaillard, L., Barouki, R., Blanc, E., Coumoul, X. & Andréau, K. Per- and polyfluoroalkyl substances as persistent pollutants with metabolic and endocrine-disrupting impacts. Trends Endocrinol Metab (2024) doi:10.1016/j.tem.2024.07.021
- Lockington, C. & Favetta, L. A. How Per- and Poly-Fluoroalkyl Substances Affect Gamete Viability and Fertilization Capability: Insights from the Literature. J Xenobiot 14, 651–678 (2024).
- Baker, N. A. et al. Coplanar polychlorinated biphenyls impair glucose homeostasis in lean C57BL/6 mice and mitigate beneficial effects of weight loss on glucose homeostasis in obese mice. Environ Health Perspect 121, 105–10 (2013).
- Pascali J et al. Per- and polyfluoroalkyl substances (PFAS) presence in food: Comparison among fresh, frozen and ready-to-eat vegetables - PubMed Food Chem 410, (2023)
Pesticides & herbicides
Herbicides and pesticides contain chemicals that can harm human health, especially with long-term exposure. These substances are linked to respiratory issues, hormone disruption, and an increased risk of cancers and neurological disorders. Regular exposure, even in small amounts can accumulate in the body, leading to chronic health problems.
- Vasseur, C. et al. Glyphosate presence in human sperm: First report and positive correlation with oxidative stress in an infertile French population. Ecotoxicol Environ Saf 278, 116410 (2024).
- Kurrasch et al. Glyphosate toxicity: in vivo, in vitro, and epidemiological evidence , Toxicological Sciences, Volume 192, Issue 2, Pages 131–140 (2023)
- Marcoccia et al. Overview of human health effects related to glyphosate exposure. Front. Toxicol. Volume 6 (2024)
- Lushchak O. et al. The effects of low-toxic herbicide Roundup and glyphosate on mitochondria - PMC. EXCLI Journal Jan Pages 183-196 (2022)
- . 2022 Jan 10;21:183–196
Inflammation
Exposure to forever chemicals and microplastics can trigger chronic inflammation in the body, as they aren’t easily broken down or removed. This persistent inflammation harms healthy tissues and is linked to serious health issues, including heart disease, cancers, neurodegenerative diseases and immune dysfunction. Over time, these inflammatory responses increase the risk of chronic illness and disrupt the body’s natural balance.
- Choi C, De Simone N, Webb CB, et al. Plasma Adsorption with the MTx.100 Column in Critically Ill COVID-19 Patients: A Prospective Study and Propensity Score Analysis Journal of Intensive Care Medicine. 2024;0(0). doi:10.1177/08850666241280031
- Gonzalo, R. et al. Plasma exchange with albumin replacement for Alzheimer's disease treatment induced changes in serum and cerebrospinal fluid inflammatory mediator levels - Gonzalo - Annals of Clinical and Translational Neurology - Wiley Online Library. Annals of Clinical and Translational Neurology, Wiley Online Library (2024)
- Furman, D. et al. Chronic inflammation in the etiology of disease across the life span. Nat Med 25, 1822–1832 (2019).
- Zafar, K., Azuama, O. C. & Parveen, N. Current and emerging approaches for eliminating Borrelia burgdorferi and alleviating persistent Lyme disease symptoms. Front Microbiol 15, 1459202 (2024).
- Peluso, M. J. & Deeks, S. G. Mechanisms of long COVID and the path toward therapeutics. Cell 187, 5500–5529 (2024).
- Kiprov et al. Case Report: Case Report: Therapeutic and immunomodulatory effects of plasmapheresis in long-haul COVID (2023)
- Heneka, M. T. et al. Neuroinflammation in Alzheimer’s disease. Lancet Neurol 14, 388–405 (2015).
- Tansey, M. G. et al. Inflammation and immune dysfunction in Parkinson disease. Nat Rev Immunol 22, 657–673 (2022).
- Boada, M. et al. A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer’s disease: Primary results of the AMBAR Study. Alzheimer’s & Dementia 16, 1412–1425 (2020).
- Boada, M. et al. The use of plasma exchange with albumin replacement in the management of Alzheimer’s disease: a scoping review. Alzheimer’s & Dementia 16, 1412–1425 (2024).
- Fuentealba m. et al Multi-omics Analysis Reveals Biomarkers that Contribute to Biological Age Rejuvenation in Response to Therapeutic Plasma Exchange | medRxiv Doi: https://doi.org/10.1101/2024.08.02.24310303 (2024)
- Aggarwal, R. et al. Serum free light chains as biomarkers for systemic lupus erythematosus disease activity. Arthritis Care Res (Hoboken) 63, 891–8 (2011).
- Hamza, W. M. & AlEssa, A. M. Coincidental light chain induced proximal tubulopathy with lupus nephritis: a case report and review of the literature. J Med Case Rep 15, 388 (2021).
- Orisaka, M. et al. Chronic low-grade inflammation and ovarian dysfunction in women with polycystic ovarian syndrome, endometriosis, and aging. Front Endocrinol (Lausanne) 14, 1324429 (2023).
- Buergel, T. et al. Metabolomic profiles predict individual multidisease outcomes. Nat Med 28, 2309–2320 (2022).
- Shi et al. The role of inflammation in autoimmune disease: a therapeutic target - PMC Front Immunology doi: 10.3389/fimmu.2023.1267091 (2023).