Hepatocellular Carcinoma (HCC) Test | KSL Diagnostics

Hepatocellular
Carcinoma
(HCC)

Advancing diagnosis of Hepatocellular Carcinoma (HCC) with a novel assay for Liver Cancer-Secreted Serine Protease Inhibitor Kazal (LC-SPIK) Biomarker

LC-SPIK Test available as Clinical Trial Assay only

Test Background

HCC is the most common and deadly liver cancer, with nearly 1 million new cases annually and a 5-year survival rate below 15% due to late diagnosis. Early detection of HCC significantly improves clinical outcomes, yet existing screening tests like ultrasound and α-fetoprotein (AFP) fall short in accuracy, especially in early-stage disease. Ultrasound is operator-dependent, considered suboptimal in patients with obesity and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). AFP shows poor clinical sensitivity (<40%) for detecting HCC in early stage and cirrhosis patients, particularly in non-viral cirrhosis.

Novel Diagnostic for HCC

ImCare Biotech discovered and developed LC-SPIK, a liver cancer-secreted form of serine protease inhibitor Kazal uniquely produced by tumor cells but not by normal hepatocytes or inflamed tissue. Retaining an extra 23-amino-acid N-terminal fragment, LC-SPIK is specifically detected by the Seravue® ELISA, a proprietary immunoassay platform, enabling highly sensitive and specific HCC detection, including AFP-negative and cirrhotic cases across diverse populations. Seravue® has received FDA Breakthrough Device Designation for HCC diagnosis.

Studies demonstrate significant improvements in performance of LC-SPIK over AFP as a single biomarker.

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LC-SPIK has exceptional diagnostic power in AFP-negative HCC, accurately identifying tumors that escape AFP detection across both viral and non-viral etiologies. This superior performance underscores LC-SPIK’s potential as a transformative biomarker for uncovering hidden early-stage HCC cases.

Clinical Trial

The Seravue® Validation Study for HCC Diagnosis (NCT06994130) has been initiated to test the performance of the Seravue® LC-SPIK test alone and in combination with other HCC diagnostic tests as a tool for HCC surveillance in diverse patient populations and clinical settings. Approximately 1,400 hepatic cirrhosis and Hepatitis B Virus (HBV) positive patients meeting eligibility requirements will be enrolled and tested through 2027. KSL Diagnostics, Inc. will perform testing as the central laboratory for this study, with NYSDOH certification of the Seravue® LC-SPIK test as a Clinical Trial Assay.

Next steps

ImCare in conjunction with KSL are continuing studies to optimize HCC diagnostics and inform treatment. Lab developed test (LDT) panels for HCC will be launched by KSL Diagnostics in 2026-2027.

Seravue® LC-SPIK ELISA Test Parameters:

KSL Test Code:	074
Assay Type	Clinical Trial Assay
Methodology	ELISA
Units	ng/mL
Sample Type	Serum
Reference Value	Normal <21.5 ng/mL Abnormal =/< 21.5 ng/mL
Specimen Requirements	Collect 5-10 ml of blood in a red top or serum separator tube. Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to a Standard Transport Tube.
Requested Specimen Volume	2 mL

About ImCare

ImCare Biotech is a biotechnology company founded in 2011. The company’s primary products in development are innovative diagnostic biomarkers as well as developmental drugs for the treatment of liver diseases such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma. ImCare Biotech’s main R&D center includes a modern fully-equipped laboratory focused on molecular biology and tissue cultures.

Visit ImCare Biotech at Booth #1045 at AASLD The Liver Meeting 2025, November 7–11 in Washington, D.C.

About KSL

KSL Diagnostics Inc. delivers innovative diagnostics that improve patient outcomes, particularly in cases requiring early diagnosis to facilitate effective therapy — with research and manufacturing units certified to ISO 13485 and registered with FDA that support clinical laboratories licensed for testing throughout the United States. The rapidly expanding test menu includes leading edge assays based on KSL IP as well as standard of care diagnostics supported by superlative clinical consultation and customer service.

References

Lu, F., Shah, P. A., Rao, A., Gifford-Hollingsworth, C., Chen, A., Trey, G., ... & Lu, X. (2020). Clinical and translational gastroenterology, 11(12), e00271.
Lu, F., Ott, C., Bista, P., & Lu, X. (2024). Diagnostics, 14(7), 725.
Caviglia, G. P., Nicolosi, A., Abate, M. L., Carucci, P., Rosso, C., Rolle, E., ... & Bugianesi, E. (2022). Current Oncology, 29(8), 5457-5465.

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