San Diego-based Sequenom, Inc. (NASDAQ: SQNM), a provider of molecular diagnostic applications and genetic analysis products and services, and Ann Arbor-based SensiGen LLC, a privately held biotechnology company focused on developing proprietary gene-based, molecular diagnostic tests, last week announced an  expansion of their global alliance to develop and market advanced diagnostic tests and systems to commercial laboratories worldwide.

Under the expanded agreement, in addition to commercializing SensiGen’s advanced test for human papillomavirus exclusively on Sequenom’s MassArray platform, SensiGen will also be the exclusive provider of MassArray platform-based assays for SensiGen’s newly developed Chronic Kidney Disease and Lupus tests.

Sequenom will exclusively supply platform technology and reagents used for commercializing SensiGen’s proprietary tests. The expanded agreement also provides Sequenom with the future right to a minority equity interest in SensiGen. Financial terms of the alliance were not disclosed.

SensiGen’s AttoSense assays are capable of accurately identifying minute quantities -- in some cases a single copy -- of the biomarkers associated with the onset of major diseases or the pathogens that cause them. SensiGen’s assays are designed to take advantage of the high sensitivity and specificity of the MassArray system by coupling SensiGen’s state-of-the-art polymerase chain-reaction methodology, with its proprietary sample preparation methods, primers and markers, to achieve unprecedented results.
Because the mass of a biological substance is highly specific, this technique is well-suited for identifying nucleic acids that are difficult to detect accurately by current hybridization methods or are found in extremely small quantities.

In the United States, more than 55 million women are screened each year for cervical cancer at a cost of more than $2 billion. Despite screening, 9,000 new cases and 4,000 deaths from cervical cancer are reported annually, due in part to the limitations of currently available tests. In addition to the well-known Pap test, more than 7 million HPV DNA tests are conducted annually worldwide, and the total number of HPV DNA tests is growing at a rate exceeding 35 percent per year.

SensiGen’s proprietary AttoSense HPV test is a 98 percent-plus sensitive, 99 percent plus specific multiplex assay that in one step identifies the presence and quantity of all known HPV oncogenic types. The extreme accuracy versus conventional methods, attractive economics and ease of integration into current laboratory practice offered by the AttoSense HPV test provide competitive advantages and significant worldwide market potential. This assay is in late-stage development and clinical trials are expected to begin in late 2008.

Approximately 20 million Americans have some evidence of CKD and another 20 million are at risk for developing this disease. High-risk groups for which annual screening would be indicated include Type I or Type II diabetes patients, hypertensives, and patients with systemic Lupus erythematosus. In the U.S., $450 million is spent annually on kidney disease testing primarily via the micro albumin test, which only detects later stages of the disease (Stage 3 and beyond), at a time when treatment options are far less effective.

SensiGen’s proprietary AttoSense Kidney test detects a specific gene product uniquely associated with the onset of pathological processes that lead to CKD (i.e., in Stages 1 & 2 of the disease). Current testing modalities are unable to detect these processes before Stage 3, at which point extensive and irreversible kidney damage has occurred. When detected early, available treatments for CKD can arrest or significantly delay disease progression. The AttoSense Kidney Test is in late-stage development and clinical trials are expected to begin in late 2008 or early 2009.

Systemic Lupus erythemetosis is a widespread and chronic 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. If detected sufficiently early, treatments are available to help patients manage the disease and reduce the impact of periodic episodes or symptom flare-ups common to Lupus.

SensiGen is developing a test for a set of proprietary epigenetic biomarkers that have been shown to be uniquely associated with the onset and severity of Lupus. The role of epigenetics in the etiology of human diseases is becoming increasingly recognized, making it among the fastest growing fields of genetic research today. Tests for epigenetic biomarkers must accurately distinguish between subtle differences in genetic codes and must also measure the precise ratio of their quantities. SensiGen is developing an AttoSense multiplex assay for these new epigenetic biomarkers and data obtained from initial studies is promising.

More at www.sensigen.com.