The largest internal organ in the human body is the liver. The liver aids in digestion, energy storage, removal of toxins from the body, and supports many other functions. Because of the important job requirements set forth for this internal organ, evolution has assured us complete regeneration, so long as 25% of the tissue remaining is healthy.
Today on July 28th, Eurofins Central Laboratory, a member of Eurofins BioPharma Services recognizes World Hepatitis Day.
To date, Eurofins Central Laboratory has supported and continues to provide services in support of Hepatitis studies to 7,849 randomized patients spread across multiple continents, 131 countries, and over 676 sites. Supported by an industry-leading Scientific Team, assays are developed and validated to meet the specific requirements of Hepatitis Clinical Trial Programs. As our Bioanalytical Services are fully integrated in our Central Laboratory, we offer a seamless transition from the rigorous and tightly controlled environment required for primary efficacy analysis to a high-volume production testing environment under one roof.
Viral infectious diseases like Hepatitis cause acute and chronic liver disease. The World Health Organization (WHO) states that Type A, B, C, D, and E, are the five main Hepatitis viruses.
Hepatitus A virus (HAV)
Can be transmitted through contaminated food & beverages, and is known to be mild with most individuals seeking full recovery and gaining immunity. Underdeveloped countries with poor sanitation have higher rates of HAV and Vaccines are available for prevention.
Hepatitis B virus (HBV)
Can be transmitted through infected bodily fluids like blood and semen, and onto newborns from mothers during birth. Healthcare workers are at higher risks for HBV from accidental exposure such as needle stick injuries. Vaccines are available for prevention.
Hepatitis C virus (HCV)
Can be transmitted through infected blood, typically through transfusions of contaminated blood or the products used for transfusions. No vaccines are available for prevention.
Hepatitis D virus (HDV)
Infections stem from individuals already infected with HBV, resulting in a more serious/fatal outcome. HBV vaccines act as preventatives for HDV.
Hepatitis E virus (HEV)
Can be transmitted through contaminated food and beverages. HEV is more common in developing countries. Effective vaccines have been developed, but have not yet been readily made available.
It's estimated that 62 million people around the globe are affected by HCV and costs for treatment alone rose from $77 million in 2009 to $18.4 billion in 2015 (Kish & Aziz & Sorio, 2017). Today, we're actively seeing more treatments and preventatives become available and Eurofins is proud to be the Quiet Contributor of this initiative. At Eurofins, we offer quantitative serology titers for therapeutic monitoring to help our customer predict disease progression with their patients who have low HBV loads and higher hepatitis B surface antigen (HBsAg) levels in clinical trials. This service helps our customers to determine which of their patients are at an increased risk for cirrhosis and hepatocellular carcinoma (HCC).
Biomarker data that is used for decision making and for regulatory purposes, requires advanced method validation beyond CAP/CLIA verification. In Hepatitis Clinical Trial Programs, biomarkers like hepatitis B core-related antigen (HBcrAg) have been well known to be a surrogate marker for chronic hepatitis B (CHB) and are expected to be useful in disease monitoring and predicting treatment response. Our Central Laboratory is uniquely positioned with our Biomarker Center of Excellence by uniting GLP and GCP in one synergetic approach. We are one-of-a-kind in offering advanced validation for biomarker assays on clinical analyzers. Our hybrid system allows us to combine best of both worlds when utilizing laboratory biomarkers to prove safety and efficacy, support go/no-go decisions, stratify patients, develop companion diagnostics and to support the submission of data sets to regulatory agencies worldwide.
The Quiet Hero
The air we breathe, the food we eat, the water we drink, the everyday products we use, the diagnostic techniques, treatments, and medicines we rely on when we are unwell - so often we take them for granted. As we go about our daily lives, many of us scarcely notice the complex processes, scientific endeavor and rigorous testing that keep us, and the environment around us, safe and well.
As a world leader and innovator in analytical testing, Eurofins is the Quiet Hero that stands between you and the hazards of an ever-changing, highly complex world. Our continuous innovation and ceaseless vigilance mean you can trust the products you consume, the medicines you depend on, and the environment you live in. We walk beside you every day, keeping your family safe, making our world better.
Day in and day out, we are testing for life.
Speak to an Expert!
Throughout the drug development cycle, regulatory approvals are highly dependent on laboratory data generated in clinical trials. The unbiased data that a central laboratory provides is of pivotal importance in any clinical trial. It's the RESULTS THAT MATTER.
We at Eurofins Central Laboratory look forward to being a part of your Hepatitis Clinical Trial journey and participating in the ongoing research and development towards that end. Feel free to reach out to us to begin the conversation!
References:
Kish, T. & Aziz, A. & Sorio, M. Hepatitis C in a New Era: A Review of Current Therapies. PMC
US National Library of Medicine. National Institute of Health. Retrieved from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5398625/
Serum hepatitis B surface antigen levels help predict disease progression in patients with low
hepatitis B virus loads. Tai-Chung Tseng, Chun-Jen Liu, Hung-Chih Yang, Tung-Hung Su,
Chia-Chi Wang, Chi-Ling Chen, Cheng-An Hsu, Stephanie Fang-Tzu Kuo, Chen-Hua Liu, Pei-
Jer Chen, et al. Hepatology. 2013 Feb; 57(2): 441–450. Published online 2012 Dec 6. doi:
10.1002/hep.26041. Retrieved from:
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/22941922/citedby/?tool=pubmed
Hepatitis B core-related antigen (HBcrAg): an emerging marker for chronic hepatitis B virus
infection. L-Y Mak, D. K-H Wong, K-S Cheung, W-K Seto, C-L Lai, M-F Yuen Aliment
Pharmacol Ther. 2017 Oct 16 Published online 2017 Oct 16. doi: 10.1111/apt.14376. Retrieved
from: https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/29035003/citedby/?tool=pubmed
Newman, T. March 2, 2018. What does the liver do? Medical News Today. Retrieved from:
https://www.medicalnewstoday.com/articles/305075.php
World Health Organization: https://www.who.int/features/qa/76/en/
MedlinePlus: https://medlineplus.gov/hepatitis.html