Laboratory medicine is facing increasingly complex challenges these days. The need for precise, fast and reliable diagnoses is constantly increasing, while the amount and complexity of data to be analyzed is growing rapidly. Laboratory managers are under pressure to find innovative solutions to make workflows more efficient and at the same time enable better clinical decision-making through more precise diagnostics. In this context, clinically validated, CE-marked algorithms play a crucial role. They can not only increase the quality and speed of laboratory analyses, but also serve as a valuable addition to the laboratory portfolio to strengthen competitiveness. One example of this is the GAAD algorithm.

Why algorithm-based diagnostics is so relevant for liver cancer

Hepatocellular carcinoma (HCC) is one of the cancers with the worst survival rates worldwide. Survival rates for patients with HCC are alarmingly low as the disease often remains undetected for a long time and diagnoses are often made at a late stage when therapeutic options are limited. An early diagnostic approach can increase the 5-year survival rate from 5% to up to 40-70%, demonstrating the immense potential of algorithm-based diagnostics^.4

The GAAD algorithm combines the quantitative measurements of the biomarkers Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II* (protein-induced by vitamin K absence) in human serum or plasma with the patient’s age and gender. The result is a risk score, which is assessed using a clinically validated cut-off. This indicates the risk of HCC and provides the basis for further diagnostic clarifications if the result is positive. The navify® Algorithm Suite enables the integration of the GAAD algorithm into the existing system landscape and, as a central platform, provides access to a growing library of CE-marked clinical algorithms from Roche and third-party providers.

Expert opinion of Prof. Dr. Ralf Lichtinghagen, MHH

By integrating the navify® Algorithm Suite into the existing laboratory workflow at Hannover Medical School (MHH), a 90% reduction in manual work steps was achieved – from 10 steps to determine the risk score to just one step after implementation. The time saved per patient case means that savings of up to €12,000 per year can be achieved.

The Head of the Institute of Clinical Chemistry at the MHH, Prof. Dr. Lichtinghagen, emphasizes the importance of the GAAD algorithm in everyday clinical practice: “The GAAD algorithm is like a digital parameter that runs as a normal laboratory value in routine – now we no longer have any additional work. Integration via the navify® Algorithm Suite increases data security and standardizes our IVDR-compliant processes.”

Conclusion

For modern laboratories, the use of innovative technologies is essential to meet increasing demands and ensure diagnostic quality. With the GAAD algorithm, Roche’s navify® Algorithm Suite offers a solution that not only helps laboratories to make more precise and faster diagnoses, but also to develop an innovative and competitive portfolio. The support of clinically validated algorithms could thus become the decisive factor for a successful future in laboratory medicine.

Further information: https://www.roche.de/diagnostik/produkte-loesungen/digitale-loesungen/navify-algorithm-suite/navify-algorithm-suite-mhh

1 Elecys® GAAD method sheet
2 Chan et al. (2022) Poster 3345 presented at EASL ILC 2022, June 22-26, 2022. International Liver Congres
3 Chan et al. (2021) “Performance Evaluation of the Elecsys® GAAD Assay for the Detection of Hepatocellular Carcinoma Across Different Disease Stages and Etiologies” presented at ISHVLD GHS 2021, June 18-20, 2021. Global Hepatitis Summit.
4 El-Serag HB, et al, Ther Adv Gastroenterol 2011; 4(1): 5-10

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