Level Diagnostics closes a €380,000 seed-round investment with Libertatis Ergo Holding for the development of an accurate and first-in-class diagnostic kit for early-stage prediction of Hepatocellular Carcinoma.

Leiden, December 06, 2023: Levels Diagnostics (LDx), a Dutch innovative biotech start-up located in Leiden has received a €380,000 seed-round investment from Libertatis Ergo Holding B.V. (LEH) to develop a novel diagnostic tool, which can identify liver cancer at an early stage to improve patient’s survival. The investment will support our on-going work to further develop a novel diagnostic tool that can help detect hepatocellular carcinoma (HCC) at an early disease stage. This investment will further enable our validation efforts in a large, randomised HCC patient cohort to augment accuracy of the kit, before reaching regulatory approval and sales.

HCC is the most common kind of primary liver cancer (75-85%^[1]). In 2020, liver cancer accounted for approximately 906,000 new cases and 830,000 new deaths globally that year, making it the cancer type with the 6^th highest incidence and the 3^rd highest mortality across the world^[2]. Both annual new cases and deaths may rise by as much as 50% or more by 2040 if current global rates continue^[3].

The current clinical practice for HCC screening relies on ultrasonography, which provides a  test sensitivity that is sufficient for overall detection of HCC (ca 84%^[1]) but suboptimal for detection at an early disease stage (ca 47%^[1]). Patients diagnosed with early-stage HCC receiving curative treatment options currently have an average 5-year survival rate of 70% or more^[4,5]. For patients diagnosed with advanced and late-stage HCC, this rate drops to 20% and below^[4,5]. In order to improve survival for patients diagnosed with HCC, it is therefore crucial to further improve the sensitivity of HCC surveillance testing for early-stage cases.

With this problem in mind LDx started developing HEPATO Dx, a first-in-class IVD for early-stage detection of HCC in at-risk liver cirrhosis patients partaking in periodic surveillance. The test involves a customised easy-to-use ELISA kit for the detection of 4-6 early HCC-specific protein biomarkers in blood.

Coen Breedveld, CEO of Levels Diagnostics: “We are very excited to announce the investment round with LEH. We are very thankful for the trust that is put in our team and our results! With this collaboration, we aim to expand our team, increase our clinical efforts and ramp up our ELISA development capacity.”      

Rob Mayfield, Director of LEH: “We are proud to support the Levels Diagnostic’s

team ambition to dramatically improve patient survival rates associated with liver

cancer”.

ABOUT LEVELS DIAGNOSTICS

Levels Diagnostics (LDx) is a Dutch biotech start-up company that specialises in biomarker discovery, clinical studies, and the development of rapid diagnostic tools. The company was founded with the mission to develop accessible point-of-care diagnostic tests that are accurate, quick and cost-effective for global use. The vision of LDx is to pioneer innovative diagnostic tools for early disease detection, enabling effective treatments and saving lives. We aim to introduce a first-in-class IVD with a superior performance for the early detection of HCC in liver cirrhosis patients.

ABOUT LEH:

Libertatis Ergo Holding B.V. (LEH) is an independent lead seed investor which supports science based startup companies connected to the activities of Leiden University, with a strong focus in life science and health. www.libertatisergo.com

Coen Breedveld, CEO Levels Diagnostics (LDx)

coen@levels.bio

Citations:

[1] Singal AG, Lampertico P, Nahon P. Epidemiology and surveillance for hepatocellular carcinoma: New trends. J Hepatol. 2020;72(2):250-261. doi:10.1016/j.jhep.2019.08.025

[2] Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660

[3] Rumgay H, Arnold M, Ferlay J, et al. Global burden of primary liver cancer in 2020 and predictions to 2040. J Hepatol. 2022;77(6):1598-1606. doi:10.1016/j.jhep.2022.08.021

[4] Llovet JM, Kelley RK, Villanueva A, et al. Hepatocellular carcinoma. Nat Rev Dis Prim. 2021;7(1):6. doi:10.1038/s41572-020-00240-3

[5] Calderon-Martinez E, Landazuri-Navas S, Vilchez E, et al. Prognostic Scores and Survival Rates by Etiology of Hepatocellular Carcinoma: A Review. J Clin Med Res. 2023;15(4):200-207. doi:10.14740/jocmr4902