Ampel BioSolutions, LLC
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.
Inclusion Criteria: 1. Male or female aged at least 18 years old. 2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation 3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician 4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing Exclusion Criteria: 1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e…
LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE