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:

  1. LuGENE® Immune Activity Score
  2. Lupus patient subgroup (endotype)
  3. 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

LuGENE® Program

LuGENE® Launching at the Following Practices

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 info@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.​

AMPEL BioSolutions is a precision medicine company commercializing a development pipeline of CLIA-certified gene expression tests.

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