Detection of HER2 in Urine to Diagnose Lupus Nephritis (LN)


Point-of-care biomarker for Systemic Lupus Nephritis


Market Need


Systemic Lupus Erythematosus (SLE) is an autoimmune disease that varies in severity in which the patient’s immune system mistakenly attacks healthy tissues in the body. Lupus Nephritis (LN) is kidney inflammation, which is a complication of SLE that causes decreased kidney function. LN is often difficult to diagnose because the symptoms, which include painful swollen joints, fever, feeling tired, and swollen lymph nodes, can vary and be misdiagnosed for other diseases. Currently, diagnosing LN requires a non-definitive battery of non-specific tests, including blood tests, ultrasound, and even kidney biopsy, which often require further patient monitoring to determine diagnosis. In order to administer anti-inflammatory treatments sooner and to be able to monitor LN treatment, a more definitive biomarker for LN is needed.


Technology Overview


The inventors have shown that increased levels of HER2 protein are detectable in the urine of LN patients. Furthermore, they also show that HER2 levels are increased in LN patients undergoing active flares when compared to non-active LN, suggesting the possible utility of HER2 in the urine to predict or monitor LN flares and treatment regimens. Detection was performed using an ELISA assay, which is amenable to adaption to a point-of-care diagnostic test.



•       Non-invasive biomarker for LN that can be measured in urine

•       Could be used to monitor LN treatment

•       Can be adapted to point-of-care diagnostic format


•       Non-invasive diagnosis of LN

•       Monitor LN flares and disease treatment


Stage of Development: In vivo proof of concept


Case ID:
Web Published:
Patent Information:
Title Country Serial No. Patent No. File Date Issued Date
Compositions and Methods for the Diagnosis and Treatment of Lupus Nephritis United States 62/381,982 8/31/2016  
For Information, Contact:
Cassie Tran
Licensing Associate
The Children's Hospital of Philadelphia
Kathleen Sullivan
Ana Patricia Costa Reis
Chronic Disease