New Lupus Test Predicts Flares & Drug Targets

May 10, 2024 | News, Lupus, Lupus 2022, Products


Summary: AMPEL BioSolutions is launching a predictive AI-driven blood test for Lupus that forecasts patient flares and drug targets from gene expression.


  1. LuGENE detects Lupus flares before they occur, providing doctors with crucial information for timely, evidence-based treatment decisions.
  2. The test identifies specific patient subgroups and drug targets, enabling personalized treatment by matching patients to therapies like Benlysta and Anifrolumab.
  3. LuGENE ensures predictive accuracy across different ethnicities, addressing a critical need for effective Lupus care in underrepresented communities.

AMPEL BioSolutions is launching the LuGENE Lupus blood test—which forecasts patient flares and drug targets from gene expression utilizing predictive AI—at several Lupus practices around the country.

The test will be made available at medical centers, concierge practices, and healthcare systems as a practical decision-support biomarker test that could greatly impact day-to-day healthcare for patients with Lupus.

AMPEL BioSolutions’ Blood Test for Lupus

The blood test predicts flares before they happen and provides specific information about a patient’s disease abnormalities leading to symptoms, allowing physicians to make evidence-based decisions regarding therapy including whether a patient is stable on their current therapeutic regimen. There are a million and a half lupus patients in the U.S. that could benefit from LuGENE by preventing unexpected flares and shortening the time to disease-controlling therapy, tha company says.

Spotting Abnormalities

From RNA gene expression in cells circulating in the blood, LuGENE identifies real-time abnormalities leading to inflammation and immune system dysfunction that are targetable by medication. Some abnormalities are well-known and others are novel. Until now, therapeutic intervention is a trial-and-error endeavor that often takes years until a patient is stabilized without further threat of organ-damaging flares.

LuGENE clarifies that there are eight subgroups that make up the universe of Lupus patients, the reason why getting the right drug to the right patient at the right time has been so challenging, as until now physicians did not have a tool to know what drug targets are abnormal in their patient. AMPEL’s approach pinpoints the patient subgroup(s) that express the target of one or both of the FDA-approved drugs for lupus, Benlysta and Anifrolumab, providing decision support for physicians to potentially shorten the time to effective therapy and potentially improve quality of life.

“Currently, there is no way to predict flares or determine which treatment is most appropriate for each patient, and in many instances it can take many years for some patients to find the most effective one to manage their disease,” says Peter Lipsky, MD, co-founder and CEO/CMO of AMPEL BioSolutions. “Healthcare professionals can now know whether a flare in disease activity in imminent and if the disease is not controlled, LuGENE can identify the specific targets of therapies that are more likely to provide relief.  The LuGENE blood test is a monitoring biomarker that provides essential information to support personalized management for each individual lupus patient.”

The Impact of Lupus

Diversity across ancestries is a hallmark of Lupus and the AMPEL R&D team included patients from all ethnicities to ensure that LuGENE is predictive for all patients in the United States living with Lupus. This is especially important as Lupus emerges earlier and with greater severity in African-American, Asian, Native-American and Hispanic/Latinx communities shortening life-span.

Further reading: New Biomarkers for Active Lupus Nephritis Discovered

Lupus has been called the “cruel mystery” because until now doctors have few objective metrics to assess whether their patient is stable with low risk of flare.  Patients with Lupus experience inflammation and pain from their immune system attacking their own organs and tissues with the same vigor as fighting off an infection. Roughly 95 percent of Lupus patients have experienced a flare in the last year. Symptoms including extreme fatigue and “brain fog” that impact daily activities, including work and family life, has led to Lupus being referred to as an “invisible disability”.

“Lupus is a very complicated disease that is pleomorphic in nature and very difficult to treat,” says Daniel Wallace, MD, author of Dubois SLE and The Lupus Book & Rheumatologist at Cedars-Sinai, UCLA, Wallace-Lee Center and BoD member of the Lupus Research Alliance affiliate Lupus Therapeutics and LupusLA, “The LuGENE blood test is a novel and innovative approach that has the potential to revolutionize the way heterogenous Lupus patients are managed by identifying their genomic biomarker fingerprint and predict if the disease is stable (or not) and what drug targets are abnormal indicating therapeutic options to consider.”

A Lupus Foundation of America survey found that 55 percent of patients with Lupus reported a complete or partial loss of their income because they no longer are able to work full time due to complications of lupus; one in three have been temporarily disabled by the disease, and one in four currently receive disability payments.

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