Elecsys® GAAD test for the aid in diagnosis of early-stage HCC
Heptocellular Carcinoma (HCC) is a "silent killer". It develops unseen, often only to be found when it’s too late to save patients. It is already the third leading cause of cancer death,1 and the global incidence of HCC is increasing, especially in developed countries.2
But it doesn’t have to be that way. We refuse to let it continue as a "silent killer". We’re turning up the volume on HCC.
Healthcare is rapidly shifting, towards more personalised care that’s more in tune with patients, embracing digital technologies that enable new possibilities. At Roche, we are shaping a new class of diagnostic algorithms.
Introducing the Elecsys® GAAD in-vitro diagnostic multivariate index assay. It is a CE-marked algorithm to help you diagnose early stage HCC and save lives. Combining Elecsys® AFP and Elecsys® PIVKA-II assay results, along with gender and age, Elecsys® GAAD communicates patients’ risk factor clearly, so you may be able to evaluate earlier and save more lives.
It’s simple and intuitive to use, and can be adapted to your current workflow, so there will be no disruption to you.
Elecsys® GAAD is an in vitro diagnostic multivariate index assay intended to provide a semi-quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP assay and Elecsys® PIVKA‑II assay in human serum and plasma with gender and age. Elecsys® GAAD is intended as an aid in diagnosis of early stage Hepatocellular Carcinoma (HCC).
Elecsys® GAAD is indicated for adults who meet the following criteria: diagnosis of chronic liver disease and recommended for surveillance due to increased risk of developing HCC.
Elecsys® GAAD must be interpreted in conjunction with other diagnostic findings and clinical information in accordance with standard clinical management guidelines.
Crystal clear
Elecsys® GAAD gives you an easy-to-understand and accurate risk score3
CE-marked
Elecsys® GAAD is a CE-marked digital tool for aid in diagnosis of early stage HCC
Can be seamlessly integrated
Can be integrated to your LIS easily with your current workflow
Committed partner
Trust Roche to help STOP Chronic Liver Disease
Ending the silence
HCC is often diagnosed in its advanced stages – when 5 year survival rates can be as low as 5%4 – because early stages are asymptomatic, and it can be difficult to gauge each patient’s risk factor.
HCC develops in patients with chronic liver disease5, but this can happen at any stage over up to 30 years.6
Amplifying your confidence
We engineered the Elecsys® GAAD to be truly simple and speedy to set-up and use. However, you’re never alone. We have created support materials to aid your interpretations and ensure that you are always confident in your next step.
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Amplifies the effectiveness of AFP
Ultrasound will always be a useful tool in HCC diagnosis. However, it has its limitations; readings can be compromised by obesity, fibrotic changes, and even the quality of device or user experience.7-9
But combining ultrasound with HCC-specific biomarkers, as Elecsys® AFP does, increases sensitivity for detecting early-stage HCC.10
Furthermore, the performance of Elecsys® AFP can be improved by including this biomarker in Elecsys® GAAD together with Elecsys® PIVKA-II, gender and age. Elecsys® GAAD showed a higher performance of detecting early stage HCC.13
Instant result of GAAD score
Elecsys® GAAD is a simple yet sophisticated algorithm.
All you need to do enter 4 simple patient data points3 into the calculator, and in an instant you’ll be given a result: a risk-factor score from 0-10, to accurately predict how likely that patient is to develop HCC.3 The score is accompanied by a built-in result interpretation to help guide your next clinical decision.
Ultrasound alone12 45%
Elecsys® GAAD provides high sensitivity and high specificity3
Ultrasound + AFP12 63%
Age
Elecsys® AFP result
Gender
Elecsys® PIVKA-II result
| Early-stage HCC | CLD controls | ||
| Elecsys assay/algorithm (cut-off) | Sensitivity | AUC b) | Specificity a) |
| AFP (20 ng/ml) | 36.4(27.4-46.3) | 82.4 % (77.4-87.5) | 98.2(95.4-99.5) |
| GAAD (2.57) | 72.9(63.4-81.0) | 91.3 % (88-94.6%) | 92.2(87.9-95.4) |
PRECAUTION: Assay results from other manufacturers have not been validated for the use of the Elecsys® GAAD test. The Elecsys® GAAD test should not be used without an independent clinical/radiological evaluation for the diagnosis of Hepatocellular Carcinoma (HCC). For each Elecsys® GAAD determination the measurement of the Elecsys® AFP and Elecsys® PIVKA-II assays must be determined from the same sample and measurement performed on the same analyzer type (either on cobas e 402, cobas e 411, cobas e 601, cobas e 602 or cobas e 801 analyzers).
