Healthcare Industry News: chronic kidney disease
News Release - January 26, 2009
Sequenom Expands Molecular Diagnostics Portfolio with Acquisition of SensiGenSensiGen Proprietary AttoSense(TM) Assays for HPV, Cervical Cancer and Other Diseases Complement Sequenom's Growing Noninvasive Test Portfolio
SAN DIEGO & ANN ARBOR, Mich.--(HSMN NewsFeed)--Jan. 26, 2009--Sequenom, Inc. (NASDAQ:SQNM) announced an agreement to acquire the complete AttoSense(TM) portfolio of tests along with certain other assets from privately held biotechnology company SensiGen LLC. SensiGen has been developing advanced gene-based molecular tests with diagnostic potential under a partnership agreement with Sequenom. The acquisition includes analytically validated, ultra-sensitive and ultra-specific tests for detection and monitoring of human papillomavirus (HPV) -- the primary cause of cervical and head and neck cancers, systemic lupus erythematosus (Lupus), chronic kidney disease (CKD), inflammatory bowel disease (IBD), as well as other tests, all of which utilize Sequenom's proprietary MassARRAY(R) platform.
"The addition of SensiGen's AttoSense tests to our portfolio represents a key step toward Sequenom's goal to have a comprehensive offering of molecular diagnostics for women's health and cancer," said Harry Stylli, Ph.D., President and Chief Executive Officer of Sequenom. "Although we believe this technology represents a future growth opportunity, the management of Sequenom remains keenly focused on the noninvasive prenatal diagnostic franchise and in particular our Down syndrome technology. As such, the cost of further development of the AttoSense assays will be immaterial to our overall R&D spend."
Dr. Stylli added, "AttoSense tests may provide early detection and monitoring of major health conditions and have the potential to dramatically improve health outcomes, while reducing overall health care costs. As our partnership with SensiGen has progressed, we have been increasingly impressed with the capabilities of the AttoSense technology and the significant commercial potential of these tests. This acquisition is highly synergistic given our ability to rapidly bring these fully developed assets to market as laboratory developed tests (LDTs) via the Sequenom Center for Molecular Medicine in the near-term and potentially as in vitro diagnostics in the future."
"Sequenom's proven development capabilities and in-house CLIA lab facilities could dramatically accelerate the market introduction and growth of the AttoSense portfolio," said Shawn M. Marcell, President and Chief Executive Officer of SensiGen. "Sequenom's ability to offer AttoSense and SEQureDx(TM) tests directly to health care providers could allow for significantly broader and more rapid commercialization than we could achieve on our own."
SensiGen's AttoSense assays can accurately identify minute quantities - in some cases as little as a single copy - of the biomarkers that signal the onset of major diseases or the pathogens that cause them. These assays utilize the unique capabilities of Sequenom's proprietary MassARRAY System, which couples state-of-the-art Polymerase Chain Reaction (PCR) with Mass Spectrometry (MS). Because the mass of a biological substance is highly specific, this technique is well suited for identifying nucleic acid targets that are difficult to detect accurately by current hybridization methods, and/or are found in extremely small quantities. The AttoSense technology enables the use of smaller, more manageable primer sequences that take the fullest possible advantage of the capabilities of the MassARRAY System to accurately detect DNA from a wide range of biological specimens, including virus, bacterium or cell, from any biological sample, including blood, urine and tissue.
Under the terms of the agreement, Sequenom will acquire all of SensiGen's currently developed assays, including the AttoSense HPV-G and HPV-Q tests for cervical cancer, AttoSense HPV-C for head and neck cancer, the AttoSense Kidney Test and the EpiSense Lupus Panel, along with certain other assets and intellectual property rights, in a stock and cash-based transaction. The total transaction purchase price of $8.7 million includes future earn-out milestone payments.
About Human Papillomavirus (HPV)
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% per year.
SensiGen's proprietary AttoSense HPV test is a highly sensitive and specific multiplex assay that can identify the presence and quantity of all known HPV oncogenic types in a single test. The accuracy, attractive economics and ease of integration into current laboratory practice offered by the AttoSense HPV test provide competitive advantages and significant worldwide market potential.
Systemic Lupus erythemetosis (SLE) 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.
About chronic kidney disease (CKD)
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 (SLE). 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(TM) Kidney Test is in late-stage development.
Sequenom is committed to providing the best genetic analysis products that translate the results of genomic science into solutions for noninvasive prenatal diagnostics, biomedical research, translational research and molecular medicine applications, especially in women's health. The Company's proprietary MassARRAY(R) system is a high-performance (in speed, accuracy and cost efficiency) nucleic acid analysis platform that quantitatively and precisely measures genetic target material and variations. The Company has exclusively licensed intellectual property rights for the development and commercialization of noninvasive prenatal genetic tests for use with the MassARRAY system and other platforms.
Sequenom maintains a Web site at www.sequenom.com to which Sequenom regularly posts copies of its press release as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission (the "SEC") or posts certain other information to the Web site.
Sequenom(R), MassARRAY(R), and SEQureDx(TM) are trademarks of Sequenom, Inc.
About SensiGen LLC
SensiGen is a biotechnology company focused on gene-based molecular diagnostics. The Company develops advanced high value diagnostic tests to enable early detection of diseases, aimed at improving standards of care and reducing overall health care costs. Current products in development include tests for early detection of human papillomavirus (HPV), the primary cause of cervical cancer, chronic kidney disease (CKD), Crohn's disease, Lupus, and others. SensiGen's proprietary molecular diagnostic assays offer dramatic improvements over current methods. Additional information is available at www.sensigen.com.
SensiGen(TM), AttoSense(TM), and EpiSense(TM) are trademarks of SensiGen LLC.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Sequenom's anticipated acquisition of assets of SensiGen LLC, including the anticipated benefits and potential of SensiGen's assets and of the transaction as a whole, Sequenom's goal to have a comprehensive offering of molecular diagnostics for women's health and cancer, commercialization of SensiGen's assets and Sequenom's ability to bring SensiGen assets to market as laboratory developed tests, and future milestone payments, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with the timing and uncertainty of closing the acquisition, the integration of acquired assets, the uncertainty of realizing expected synergies and benefits from acquisitions, the risks of unknown costs of acquisitions, Sequenom's operating performance, demand for and market acceptance of Sequenom's products, services, and technologies, new technology and product development and commercialization particularly for new technologies, reliance upon the collaborative efforts of other parties, research and development progress, competition, intellectual property protection, government regulation, obtaining or maintaining regulatory approvals, and other risks detailed from time to time in Sequenom's SEC filings, including Sequenom's Annual Report on Form 10-K for the year ended December 31, 2007 and other documents subsequently filed with or furnished to the SEC. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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