SensiGen Options Epigenetic Biomarkers for Early Detection and Monitoring of Lupus.

ANN ARBOR, Mich. & PHILADELPHIA -- SensiGen LLC, a biotechnology company developing advanced gene-based molecular diagnostics, announced today that it has acquired an option from the University of Michigan to exclusively license a set of epigenetic biomarkers for early detection and monitoring of Lupus. The technology includes a patented panel of proprietary biomarkers for epigenetic variations of genes uniquely associated with Lupus along with related research assays. SensiGen intends to develop commercial diagnostic assays for these novel biomarkers using the Company's ultra-sensitive, ultra-specific AttoSense[TM] technology.

The technology was developed by Dr. Bruce Richardson, Professor of Medicine at the University of Michigan and Chief of Rheumatology, Ann Arbor Veterans Hospital and his colleagues. Dr. Richardson is a leader in the rapidly advancing field of epigenetics, particularly in the study of DNA methylation, which has been shown to be a primary method for turning genes on and off. Dr. Richardson discovered that the levels of methylation of certain genes were closely associated with the onset of Lupus, and he developed a set of unique, proprietary biomarkers for identifying their presence.

"This is a highly advanced and very promising panel of disease-specific biomarkers that are clearly associated with onset and recurrence of Lupus, but which to date have proven difficult to detect reliably by current methods," said Shawn M. Marcell, President and CEO of SensiGen. "This technology is especially well suited to our AttoSense[TM] platform and also fits closely with our portfolio of advanced diagnostic tests for chronic kidney disease (CKD) and cervical cancer. We are very excited about the prospects for this technology."

Systemic Lupus Erythemetosis (SLE) is a widespread and chronic (lifelong) autoimmune disease in which an individual's immune system attacks the body's own tissues and organs. An estimated 1.5 million Americans, mainly women, are currently afflicted with Lupus and 16,000 new cases are diagnosed annually. Symptoms of Lupus include extreme fatigue, painful and swollen joints, fever, skin rashes, and deterioration of kidney function. The root cause of this disease is unknown, and there is no known cure. However, if detected early enough, treatments are available to help patients manage the disease and reduce the impact of periodic episodes or "flare ups" of symptoms that are common to Lupus.

Current methods for detection and monitoring of Lupus rely on decades old techniques for measuring elevated levels of antibodies in the blood and for detecting the presence of proteins called complement activation products (CAP's). Unfortunately, the levels of antibodies and CAP's in the blood fluctuate significantly in response to many factors completely unrelated to the disease, and hence these methods have proven unreliable in clinical practice to date.

"Unlike CAP's and other targets, our panel of biomarkers is uniquely associated with lupus-restricted epigenetic changes and the DNA methylation fingerprints which regulate gene expression," commented Dr. Richardson. "An assay for this panel based on the AttoSense[TM] platform has the potential to achieve an unprecedented level of diagnostic sensitivity and specificity that could herald a true breakthrough in the diagnosis and management of Lupus."

"We are delighted at the prospect of expanding our relationship with SensiGen," said Ken Nisbet, Executive Director of the University of Michigan Office of Technology Transfer. "SensiGen has an experienced management team and a solid plan for moving this technology to market, and we are eager to support their efforts to commercialize Dr. Richardson's ground breaking work."

About SensiGen LLC

SensiGen is a development stage biotechnology company focused on gene-based molecular diagnostics. The Company develops advanced methods for early detection of diseases to improve the standard of care and reduce overall healthcare costs. Current products in development include ultra-sensitive, ultra-specific tests for detection of human papillomavirus (HPV), the primary cause of cervical cancer, chronic kidney disease (CKD), systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD), and others. SensiGen's proprietary molecular diagnostic assays offer substantial improvements over current methods, and can potentially provide significant value to patients, care givers, and insurers.

www.sensigen.com