LuGENE blood test for lupus flares, drug targets enters open-label study

Apr 8, 2024 | News, Lupus, Lupus 2022, Products


Key takeaways:

  • The blood test aims to predict lupus flares and drug targets rapidly by analyzing RNA gene expression.
  • Recruitment is underway for an open-label, multicenter U.S. trial.

LuGENE, a blood test to predict lupus flares and quickly identify drug targets, is being made available to patients around the United States through an open-label study, according to a press release from the manufacturer.

Recruitment is ongoing for the multicenter study, called ReLATE, testing how LuGENE’s (AMPEL BioSolutions) results correlate with standard evaluation of patients with systemic lupus erythematosus. Sites include Cleveland Clinic, Mayo Clinic, Yale School of Medicine and others.

“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,” Peter Lipsky, MD, co-founder and CEO/CMO of AMPEL BioSolutions, said in the release. “The LuGENE blood test is a monitoring biomarker that provides essential information to support personalized management for each individual lupus patient.”

According to the release, LuGENE analyzes RNA gene expression in cells circulating in the blood to identify triggers of inflammation and immune system dysfunction, shortening an often yearslong process of trial and error.

To develop LuGENE, researchers analyzed data from 3,166 patients with SLE and identified eight molecular endotypes. Machine learning algorithms “reproducibly separated patients into the endotypes with significant differences in clinical features, outcomes and responsiveness to therapy,” wrote the researchers, who published their data in October in Genome Medicine.

“This is a crucial tool in our fight against lupus,” Amrie Grammer, MS, PhD, co-founder, president and chief scientific officer of AMPEL, said in the release. “With LuGENE, health care providers will be able to stabilize lupus patients faster than ever before, minimize the occurrence of disruptive flares and hopefully transform lupus to a chronic condition with increased quality of life.”


Hubbard EL, et al. Genome Med. 2023;doi:10.1186/s13073-023-01251-x.

Study Details | Relationship Between Data Obtained With the LuGENE Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE) (ReLATE). Published March 26, 2024. Accessed April 1, 2024.

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