New Tests Available

Dear Valued Doctor/Clinic Manager,

Greetings from Pathlab!

At Pathlab, our partnership with your practice is foundational to advancing patient care. As we build upon a year of innovation and improvements in 2025, we are proud to support you with advanced diagnostic tools and seamless service. To further empower your practice, we are excited to introduce three new tests which we have recently launched.

Enhanced Liver Fibrosis (ELF™)

Chronic liver disease is a major cause of morbidity and mortality worldwide. Regardless of cause, disease progression typically involves fibrosis advancing to cirrhosis, followed by liver failure or hepatocellular carcinoma (HCC).

Common causes of chronic liver disease include:

·         Metabolic dysfunction–associated steatotic liver disease (MASLD / NAFLD)

·         Alcoholic liver disease (ALD)

·         Chronic viral hepatitis (HBV, HCV)

·         Primary biliary cholangitis (PBC)

·         Primary sclerosing cholangitis (PSC)

Early identification of patients at risk of disease progression is critical, as many are only diagnosed at advanced stages.

The Enhanced Liver Fibrosis (ELF™) test is a non-invasive blood test used to assess the risk of progression to cirrhosis and liver-related clinical events in patients with advanced liver fibrosis (F3–F4). It is used as a prognostic tool, alongside clinical assessment and other laboratory findings.

The ELF™ test measures three biomarkers of liver fibrosis:

·         Hyaluronic Acid (HA)

·         Type III Procollagen Peptide (PIIINP)

·         Tissue Inhibitor of Matrix Metalloproteinase-1 (TIMP-1)

These markers are combined using an automated algorithm to generate an ELF score.

Key Benefits:

·         Non-invasive alternative to liver biopsy

·         Identifies high-risk patients earlier

·         Supports clinical decision-making

·         Improves patient management and outcomes

Key Strengths of ELF Compared to Other Test in the Market:

Advantages of ELF over Test X

✔ Direct Assessment of Fibrosis

ELF measures molecular markers directly involved in extracellular matrix turnover, which is closer to the biological process of fibrosis than general liver enzyme panels or routine biomarkers.

✔ Better Evidence Base

ELF has multiple clinical studies and systematic reviews, while Test X lacks extensive independent clinical validation.

✔ Prognostic Value

ELF scores have been shown to correlate with future liver-related events and long-term risk stratification frameworks.

✔ Guideline Integration

Some liver disease management pathways (especially in NAFLD/NASH) recognize ELF as a useful tool in a stepwise diagnostic pathway, often after initial risk scores like FIB-4.

Summary

ELF Test:

·         Robust, validated non-invasive blood test for liver fibrosis.

·         Directly measures biologically meaningful fibrosis markers.

·         Large body of evidence across multiple liver diseases.

·         Widely regarded as stronger and more specific for fibrosis staging than routine tests.

Test X:

·         Uses routine serum biomarkers with AI/algorithms for general liver assessment.

·         Early stage in clinical evidence development.

·         Not as well validated for fibrosis diagnosis or prognosis.

Conclusion: While Test X may provide a broad overview of liver condition, the ELF test has clear advantages for fibrosis assessment — particularly due to its direct biomarkers, robust evidence base, and capacity to inform clinical decision-making for fibrosis staging and risk stratification in chronic liver disease.

Squamous Cell Carcinoma Antigen (SCC)

·         Squamous cell carcinoma (SCC) is a malignant tumor arising from squamous epithelium. Squamous epithelial cells form the main component of the epidermis and are also present in the lining of the digestive tract, lungs, cervix, and other organs. As a result, squamous cell carcinoma can occur at multiple anatomical sites.

·         The SCC assay is an immunoassay for the in vitro quantitative determination of squamous cell carcinoma (SCC) antigen in human serum. Measurement of SCC antigen is used as an aid in the management of patients with squamous cell carcinoma, including assessment of disease burden, monitoring of treatment response, and detection of recurrence.

CYFRA 21-1 (CYFRA)

CYFRA 21-1 is a soluble fragment of cytokeratin 19 released during tumor cell turnover.

Measurement of CYFRA 21-1 in human serum is used alone or as an adjunctive tumor marker for monitoring patients with epithelial cell carcinomas, reflecting tumor cell activity.

Its main clinical application is in:

• Lung cancer, especially non-small cell lung cancer (NSCLC)

It is also useful in other malignancies, including:

·         Small cell lung cancer (SCLC)

·         Esophageal squamous cell carcinoma (ESCC)

·         Bladder cancer

·         Head and neck cancers