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Join us for an enlightening webinar presented by Jessica Tuohy, a distinguished partner and colleague from the US, focusing on the significance of K18 as a biomarker in the development of treatments for MASH (Metabolic Associated Steatohepatitis). This webinar is essential for drug developers, doctors, researchers, and key opinion leaders in the field of metabolic liver diseases, offering deep insights and key research findings.

Event Details:

• Date: Tuesday, April 23
• Time: [1pm EDT, 7pm CET]

Webinar Overview: This session will cover several critical areas:

• – An Introduction to the Growing Epidemic of MASLD (Metabolic Associated Steatotic Liver Disease)
• – Challenges in Developing Therapies for the Treatment of MASH
• – An Overview of K18 and Its Role in MASH Pathogenesis
• – A Review of Data That Support the Value of K18 as a Biomarker for Assessing the Efficacy of Drug Candidates in MASH Clinical Trials

Who Should Attend:

• – Drug developers in the field of MASLD and MASH.
• – Physicians and healthcare professionals specializing in hepatology, gastroenterology, and related fields.
• – Medical researchers focusing on liver disease and drug development.
• – Key opinion leaders in metabolic liver diseases.

Registration: Please register here to secure your spot in this informative webinar. Registration is required to access this online event.

Additional Information: If you are unable to attend the live event, a recording will be made available to all registered participants, ensuring you can access this webinar at your convenience.

We look forward to welcoming you to what promises to be an informative and transformative session.

For more information, please contact us at marketing@vlvbio.com.

Don’t miss out on the chance to advance your knowledge in MASH treatment and diagnostics. Reserve your spot today!

We are thrilled to share a momentous achievement in our longstanding collaboration with our esteemed Japanese partners, the Institute of Immunology. This announcement comes during a meeting filled with collaboration and shared successes as Mr. Ito, Mr. Akira, and Ms. Yukiko from the Institute of Immunology paid a visit to our headquarters in Stockholm.

During this collaborative visit, we had the pleasure of discussing plans for the imminent launch of the IMMUNIS Cytokeratin 18F EIA, a project that holds significant promise in the realm of diagnostic medicine. This project has been a work of dedication and innovation, and the collaboration between VLVbio and the Institute of Immunology has been instrumental in its success!

We are happy that the IMMUNIS Cytokeratin 18F EIA has gained official approval as an In Vitro Diagnostic (IVD) for the diagnosis of Non-Alcoholic Steatohepatitis (NASH) from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan! This recognition underscores the product’s efficacy and reliability in contributing to the diagnosis and management of NASH, a condition of growing concern globaly as the epidemiology of the disease keeps increasing at an alarming rate. The need for a biomarker to identify patients with NASH and who are at risk of significant liver disease is of utmost importance, and we are happy that the Keratin 18 assay can assist in that!

_{The IMMUNIS Cytokeratin 18F EIA ELISA kit}

Of equal importance, the IMMUNIS Cytokeratin 18F EIA, developed by the Institute of Immunology, has been included in the national health insurance system in Japan. This recognition ensures widespread accessibility, facilitating broader usage of this diagnostic tool within the Japanese healthcare community.

We are pleased to announce that the official launch date for the IMMUNIS Cytokeratin 18F EIA is scheduled for February 26th to the Japanese market. This date signifies the conclusion of a meticulous research and development process and exemplifies the collaborative efforts between VLVbio and our esteemed partners at the Institute of Immunology. The IMMUNIS Cytokeratin 18F EIA, launched by the Institute of Immunology, is poised to make a substantial impact on the field of NASH diagnosis, providing healthcare professionals with an additional tool to enhance their diagnostic capabilities in Japan.

As we celebrate this milestone and the successful visit from our partners, we extend our gratitude to all individuals who have contributed to the realization of this project, including the dedicated team members and esteemed partners at the Institute of Immunology. Congratulations to you all!

• Keratin 18 in Alcohol-associated Liver Disease

• – What is ALD and what is the role of K18 in ALD?
• – How can measuring K18 aid in ALD patient management?
• – Learn about the use of K18 in early ALD diagnosis, detecting severe Alcoholic Hepatitis (AH), prognosis for survival, and predicting treatment response in ALD patient!

Click here to access the full brochure!

Metabolic Associated Steatotic Liver Disease (MASLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), has emerged as a major global health challenge. Affecting roughly 30% of the world’s population, MASLD is closely tied to the rising rates of obesity, Type 2 diabetes, and metabolic syndrome. This condition, which can progress from simple liver fat accumulation to severe stages like MASH, fibrosis or cirrhosis, requires urgent attention from healthcare professionals to manage its growing prevalence.

What is MASLD?

MASLD is a spectrum of liver diseases where excess fat builds up in the liver without significant alcohol consumption. The condition ranges from simple steatosis (fatty liver) to more severe forms like metabolic dysfunction-associated steatohepatitis (MASH), liver fibrosis, and cirrhosis. The key risk factors driving MASLD are metabolic conditions such as obesity and insulin resistance.

The Growing Global Prevalence of MASLD

Over the past few decades, the prevalence of MASLD has steadily increased across the globe. Recent studies reveal that 30% of the world’s population is affected by MASLD, a significant rise from the 25% reported in 2016. In certain regions like Latin America and the Middle East, the prevalence rates exceed 40%, driven by the increasing rates of obesity and metabolic syndrome. By 2030, the number of MASLD cases is expected to surge, particularly in Southeast Asia, North America, and Western Europe, as the global burden of metabolic disorders continues to rise (The Global Epidemic of Metabolic Fatty Liver Disease, 2024).​

This growing burden makes early detection more critical than ever. The silent progression of MASLD, particularly among high-risk groups such as those with Type 2 diabetes or obesity, often leads to late-stage liver disease by the time it’s detected. Early screening and intervention can prevent end-stage complications like cirrhosis and liver failure.

Why Early Diagnosis is Critical

Early diagnosis of MASLD is pivotal in preventing the disease from progressing to more severe stages, such as fibrosis, cirrhosis, or hepatocellular carcinoma (HCC). MASLD often develops silently, with patients experiencing few or no symptoms in the early stages. As a result, the disease can go undetected until it advances to a point where treatment options are limited, and the risk of irreversible liver damage increases.

Silent Progression to Severe Disease

Many patients with MASLD are unaware of their condition until it has progressed significantly. This is because MASLD often presents with normal liver enzyme levels, which may give a false sense of security during routine checkups. Without early intervention, MASLD can progress to MASH, a more severe form that involves liver inflammation and fibrosis. From there, the disease can further develop into cirrhosis or even liver cancer. The longer the disease goes undiagnosed, the fewer options remain for successful intervention. Detecting MASLD early provides a critical window for lifestyle changes and medical management that can reverse or slow its progression.

“I had no idea my liver was deteriorating for years. I felt fine until one day, my legs started swelling, and I felt extreme fatigue. By then, it was too late — my doctor told me I had cirrhosis, and my liver was severely damaged.” – MASLD patient with cirrhosis

Preventing Cirrhosis and Liver Cancer

Early diagnosis allows healthcare providers to implement interventions that can prevent patients from progressing to the advanced stages of liver disease. Patients with MASLD who are diagnosed early have a higher likelihood of responding to non-invasive treatments such as weight loss, dietary changes, and glucose control. Studies have shown that even a modest weight loss of 7-10% of body weight can significantly improve liver histology and prevent disease progression. When MASLD is detected at the stage of simple steatosis, the risk of developing cirrhosis or liver cancer is much lower than if the disease is allowed to progress without intervention.

In advanced stages like cirrhosis, the liver’s ability to function is severely compromised, and patients may require liver transplantation. Moreover, cirrhosis significantly increases the risk of developing hepatocellular carcinoma, a leading cause of cancer-related deaths worldwide. Therefore, detecting MASLD in its early stages can significantly reduce the incidence of both cirrhosis and liver cancer, which are often associated with poor prognoses.

Role of Non-Invasive Diagnostics

Recent advancements in non-invasive diagnostic tools have made early detection of MASLD easier and more accessible for clinicians. Tools such as imaging and serum biomarkers allow healthcare providers to assess liver fat and fibrosis without the need for invasive liver biopsies. This is particularly valuable in primary care settings, where regular screening of high-risk populations (such as those with obesity, diabetes, or metabolic syndrome) can be incorporated into routine check-ups.

These diagnostic tools also allow for risk stratification, enabling clinicians to categorize patients based on their likelihood of progressing to advanced liver disease. This helps in tailoring interventions and deciding when to refer patients to specialists for more advanced care, reducing unnecessary referrals and allowing for more efficient healthcare resource allocation.

Managing High-Risk Populations

Patients with Type 2 diabetes, obesity, and other metabolic disorders are at particularly high risk for MASLD. In fact, up to 70% of people with Type 2 diabetes and 90% of obese individuals have MASLD. Early diagnosis in these populations is crucial, as they are more likely to progress to severe liver disease. By integrating liver health assessments into regular diabetes or obesity management plans, healthcare providers can catch MASLD before it progresses, allowing for earlier lifestyle modifications and potentially reducing the burden of advanced liver disease in these high-risk groups.

Improving Patient Outcomes and Reducing Costs

Early diagnosis and intervention not only improve patient outcomes but also reduce healthcare costs in the long run. Treating MASLD in its early stages is far less costly than managing advanced liver disease, which often requires hospitalizations, expensive treatments, or even liver transplantation. Moreover, patients diagnosed early are more likely to adhere to preventative measures such as diet and exercise, which can greatly improve liver health and reduce the need for long-term medical intervention.

Conclusion

As MASLD continues to grow globally, healthcare providers must stay proactive in identifying, screening, and managing patients at risk. Early diagnosis and intervention are the keys to reducing the global burden of this disease and preventing it from reaching advanced stages.

VLVbio are dedicated to providing cutting-edge, non-invasive diagnostic solutions that enable healthcare providers to detect MASLD in its early stages. As the prevalence of MASLD rises, early detection will become increasingly vital to addressing this public health challenge. Read more on how VLVbio’s M30 Apoptosense® ELISA can be incorporated into clinics to help identify patients here!

Reda Elkhatib

As part of our ongoing effort to raise awareness about Metabolic Associated Steatotic Liver Disease (MASLD), we are exploring how advances in non-invasive testing (NITs) can transform early diagnosis. Early detection is crucial in preventing MASLD from progressing to advanced stages like fibrosis or cirrhosis, where treatment becomes more complex. NITs, such as serum biomarkers, imaging technologies, and elastography, are helping healthcare providers catch the disease before significant liver damage occurs.

Why Early Diagnosis Matters

MASLD often progresses without symptoms in its early stages, meaning patients can unknowingly live with the disease for years. By the time symptoms appear—often in the form of fatigue, abdominal swelling, or jaundice—patients may already have advanced fibrosis or cirrhosis. Early diagnosis is essential to allow healthcare providers to implement lifestyle interventions and treatment strategies that can slow or even reverse the disease.

Overview of Non-Invasive Testing Options

Traditionally, liver biopsies were the primary method for diagnosing liver diseases like MASLD. While still valuable in some cases, biopsies are invasive and may carry risks. The field has since evolved, and there are now several non-invasive methods available to assess liver health.

1. Serum Biomarkers
Serum biomarkers are among the most promising tools for detecting early liver disease. These tests measure specific proteins in the blood that are associated with liver damage, such as cell death (apoptosis) and fibrosis. Biomarkers, like the M30 Apoptosense® ELISA, help detect liver cell apoptosis, an early sign of disease progression. These tests are convenient, safe, and can be easily integrated into routine care for high-risk patients.

2. Imaging Techniques

Several imaging technologies are available to assess liver stiffness and fat content, helping clinicians evaluate liver health without invasive procedures. Elastography is commonly used to measure liver stiffness, while other imaging techniques like MRI-PDFF can quantify liver fat. These methods have significantly improved the accuracy of early diagnosis, although they may not always capture the underlying biochemical changes that serum biomarkers detect.

Both biomarkers and imaging tools offer valuable insights into liver health, and each has its place depending on the patient’s condition and risk factors. When used together, these technologies can provide a comprehensive view of liver disease progression.

How Non-Invasive Tests Improve Patient Outcomes

By utilizing non-invasive tests, healthcare providers can screen high-risk populations—such as individuals with obesity, Type 2 diabetes, or metabolic syndrome—more frequently and with less discomfort to the patient. This allows for:

Ongoing Monitoring: NITs allow clinicians to monitor disease progression and treatment effectiveness over time, adjusting interventions as needed.

Earlier Interventions: Once MASLD is diagnosed, patients can begin lifestyle changes (such as diet and exercise) or medical treatment earlier, improving the likelihood of reversing or halting the disease.

Cost-Effectiveness of Early Diagnosis

Early detection not only improves patient outcomes but also offers significant cost savings for healthcare systems. A study found that managing liver disease at earlier stages can reduce healthcare costs by up to 50% compared to treating advanced-stage complications such as cirrhosis or liver cancer (Younossi et al., Journal of Hepatology, 2020). In the U.S., the annual healthcare costs related to MASLD are estimated to exceed $100 billion, a number that continues to rise as MASLD prevalence increases (Younossi et al., Hepatology, 2020).

Research also highlights that patients with cirrhosis incur nearly 4.5 times higher medical costs than those diagnosed early. For example, annual direct medical costs for patients with cirrhosis are approximately $35,000, compared to $7,800 for those diagnosed at earlier stages (Tapper et al., Hepatology, 2020; Younossi et al., Journal of Hepatology, 2020). Early diagnosis can therefore prevent the need for expensive treatments such as hospitalizations and liver transplants, significantly reducing the economic burden on healthcare systems.

Conclusion

Non-invasive testing has opened new doors in the early diagnosis and management of MASLD. From serum biomarkers to imaging techniques, these tools are making it easier for healthcare professionals to diagnose liver disease before it progresses. By using these advanced diagnostics, clinicians can help prevent severe outcomes and improve patient quality of life. VLVbio is proud to support this shift toward earlier, more accurate detection through our non-invasive testing solutions. Read more here!

Reda Elkhatib

Metabolic Associated Steatotic Liver Disease (MASLD) is a growing global health concern, with many patients unaware of their condition until significant liver damage has occurred. Early diagnosis is critical, but what happens after a patient is diagnosed? The next step is effective management to prevent disease progression and improve liver health outcomes.

In this post, we explore how lifestyle interventions and diagnostic tools can help patients manage MASLD and how healthcare providers can play a pivotal role in long-term care.

The Role of Lifestyle Changes in MASLD Management

Lifestyle interventions are currently the cornerstone of MASLD management. Studies show that losing just 7–10% of body weight can significantly improve liver health by reducing liver fat, inflammation, and fibrosis (Vilar-Gomez et al., Hepatology, 2015). Patients are often advised to:

1. Adopt a Healthy Diet:
   Diets like the Mediterranean diet, which emphasize fruits, vegetables, whole grains, and healthy fats, have been shown to improve liver function. Reducing sugar and saturated fat intake is also crucial.
   
2. Increase Physical Activity:
   Regular exercise, including aerobic and resistance training, can reduce liver fat and improve metabolic health.
   
3. Maintain Consistency:
   Adherence to these changes is key. Providing patients with tailored recommendations and ongoing support can make a significant difference in sustaining these changes.

Healthcare providers play a crucial role in educating patients about these interventions and monitoring their progress over time.

The Importance of Monitoring Tools

In managing MASLD, effective monitoring is essential for assessing treatment efficacy, tracking disease progression, and preventing advanced liver conditions such as cirrhosis. While lifestyle changes are central to improving liver health, non-invasive tools provide valuable insights that guide clinical decision-making and optimize patient outcomes.

The Role of Serum Biomarkers
Among the available tools for MASLD monitoring, serum biomarkers have gained significant attention due to their ability to detect ongoing liver injury and apoptosis. The M30 Apoptosense® ELISA (M30®), which measures caspase-cleaved keratin18 (ccK18), provides a window into hepatocyte apoptosis, an early indicator of liver damage. Research has demonstrated its utility in diverse clinical scenarios:

In a randomized trial, M30® was used to evaluate the impact of weight loss through liraglutide treatment and lifestyle modifications in patients with MASLD. The study showed significant reductions in M30® levels, reflecting improvements in liver injury alongside reductions in body weight and liver fat (Khoo et al., Liver International, 2019).

Following bariatric surgery, M30® identified ongoing liver injury in some patients, even as weight loss improved overall metabolic health. This insight proved valuable for tailoring follow-up care (Hempel et al., Journal of Clinical Medicine, 2021​)

By detecting apoptotic activity, M30® provides clinicians with a reliable tool to monitor treatment progress and refine therapeutic strategies.

Complementary Imaging Techniques

In addition to serum biomarkers, imaging techniques such as transient elastography and MRI-based modalities play an important role in assessing liver fat and fibrosis. These tools complement biomarkers by providing structural insights into liver health, allowing for a more comprehensive evaluation of MASLD progression.

While imaging tools are effective, their availability may be limited in some settings due to cost or logistical challenges. This underscores the value of biomarkers like M30®, which are accessible and scalable for routine monitoring.

Integrating Monitoring into MASLD Care

The integration of non-invasive tools into MASLD management offers several benefits:

Enhancing Patient Engagement: Demonstrating objective improvements in liver health can motivate patients to adhere to therapeutic regimens and lifestyle adjustments.

Identifying Non-Responders: Regular monitoring allows clinicians to identify patients who may not be responding to interventions, enabling timely adjustments to care plans.

Tracking Long-Term Progress: Tools like M30® provide measurable feedback on the impact of lifestyle changes and pharmacological treatments over time.

A Balanced Approach to MASLD Monitoring

Effective MASLD management requires a combination of approaches, including biomarkers, imaging, and clinical assessments. The M30 Apoptosense® ELISA is a valuable component of this toolkit, offering an accessible method for assessing liver health and tracking treatment outcomes. Paired with imaging and clinical evaluations, M30® can help healthcare providers develop personalized and proactive care plans for their patients.

Preventing Progression to Advanced Liver Disease

Effective MASLD management can prevent progression to advanced conditions like cirrhosis or hepatocellular carcinoma (HCC). Regular follow-up using non-invasive tools allows healthcare providers to:

• – Identify patients at risk of progression early.
• – Adjust treatment plans based on real-time data.
• – Reassure patients when improvements are seen, encouraging adherence to lifestyle changes.

Studies suggest that consistent monitoring and management can significantly reduce the incidence of severe liver outcomes, improving both patient quality of life and healthcare cost efficiency (Younossi et al., Journal of Hepatology, 2020).

A Collaborative Approach to MASLD Care

Managing MASLD requires a collaborative approach between healthcare providers and patients. Shared decision-making, clear communication, and personalized care plans are essential to ensure long-term success. Non-invasive tools like serum biomarkers and imaging are valuable assets in this process, helping both clinicians and patients stay informed about disease progression and treatment outcomes.

MASLD management doesn’t end with diagnosis. Lifestyle changes and ongoing monitoring are critical to improving liver health and preventing severe complications. By incorporating non-invasive tools like M30 Apoptosense® ELISA into routine follow-up care, healthcare providers can better track treatment effectiveness and support patients on their journey to better health.

As MASLD prevalence continues to rise, combining lifestyle interventions with advanced diagnostic tools is essential to addressing this global health challenge. VLVbio is proud to support this shift toward earlier, more accurate detection through our non-invasive testing solutions. Read more here!

Reda Elkhatib

We are heading to Milan for the EASL Congress together with the European Association for the Study of the Liver!

We’re happy to yet again be exhibiting at the face-to-face #EASLcongress with EASL | The Home of Hepatology! We are happy to yet again be an industry partner for the biggest liver event in Europe!

The latest in hepatology is happening 📅 5–8 June.
🤝 Join us at the highlight of the year! Register today, and lets meet and discuss liver biomarkers at our booth.