LDT Blood Test for Personalized Lupus Patient Management
Providing dynamic genomic information based on AI-powered RNA analytics to support clinical decision making by Physicians caring for Lupus Patients
What information does LuGENE® provide?
- For the first time, a health care professional can know whether current therapy is controlling the immune activity underlying clinical features of lupus.
- When disease is not controlled, the targets of new therapy are revealed.
- Knowledge of the Immune Profile of each patient from AI powered RNA analytics provides the necessary information to support precise and personalized decision making.
The LuGENE® Principle
3-in-1 Lupus Biomarker provides decision support to HCPs caring for lupus patients
STATUS
Disease Control
LuGENE® reveals whether current treatment has controlled all immune activity in each patient. The goal of treatment is to attain endotype A or a LuGENE® score of <3.56, indicating no abnormal immune activity.
PROGNOSIS
Flare Forecast
Endotype A or LuGENE® score <3.56 indicates that current treatment is controlling immune reactivity and severe flare is unlikely.
PREDICTION
Treatment Targeting
LuGENE® identifies specific immune activity in each patient that can be targeted with new treatment.
The Process
LuGENE® is a CLIA certified Laboratory Developed Test (LDT) that employs AI Powered RNA analytics to identify the immune profile of each patient with lupus.
Blood Draw
LuGENE® requires a simple blood draw of 2 ml.
Results Available
Results are routinely available with 7-10 days.
Report
The LuGENE® Report provides easy to understand and comprehensive information for each person with SLE including:
- LuGENE® Immune Activity Score
- Lupus patient subgroup (endotype)
- Genomic profile of cells, functions and pathways
LuGENE® Report
Status
LuGENE® Immune Activity Score:
Provides insight into overall immune status. Helps to anticipate an individual’s risk of oncoming flares through measuring immune activity.
Activity
LuGENE® Gene Module Profiles:
Characterizes unique immune activity through assessing up and down regulation of key cellular and immune pathways. Provides clinical insight for treatment decision support.
Insights
LuGENE® Molecular Endotypes:
Leveraging RNA Analytics and Machine Learning, LuGENE® accurately subsets individuals into 1 of 8 possible unique molecular Endotypes. Endotype membership indicates disease status, forecasts flares and identifies targets of new treatment.
How was LuGENE® developed?
- AMPEL has developed a library of informative gene sets (modules) that precisely identify specific cell types and molecular processes.
- 32 gene modules that are informative of lupus biology were selected by machine learning.
- LuGENE® was developed from analysis of 3,166 samples from 17 datasets and identifies abnormal enrichment of any of 32 specific gene modules and employs a machine learning model to assign each sample to one of 8 subsets (endotypes) that define the universe of lupus immune activity.
Highlighted LuGENE Publications
Genome Medicine
Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications
iScience
An interpretable machine learning pipeline based on transcriptomics predicts phenotypes of lupus patients
JCI Insight
Patient ancestry significantly contributes to molecular heterogeneity of systemic lupus erythematosus
The LuGENE® Program
Follow-on clinical studies to identify further uses of LuGENE® will be enrolling soon.
LuGENE® is Built on a Privacy Safe Foundation
LuGENE® is built in a HIPAA-compliant manner to provide data privacy.
LuGENE® testing will be offered in all 50 states.
Speak to a LuGENE® Team Representative
Please submit a contact form below or contact the AMPEL team at support@ampelbiosolutions.com to set up an online account and find out more about how LuGENE® can provide SLE clinical decision support.
Please note: At this time, only health care providers can order LuGENE directly through a clinical study. If you are a patient looking to try LuGENE, please consult your physician.
