Placement Marks Commercial Launch of the Vantera Clinical Analyzer for Clinical Labs
RALEIGH, N.C. – May 22, 2013 – LipoScience, Inc., (NASDAQ: LPDX) a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care, today announced availability of NMR lipoprotein particle testing using the Vantera Clinical Analyzer through Mayo Medical Laboratories.
NMR lipoprotein testing on the Vantera Clinical Analyzer will be accessible to Mayo Clinic physicians and patients and other hospital clients of Mayo Medical Laboratories. The Vantera Clinical Analyzer can identify and quantify concentrations of lipoproteins using NMR spectroscopy and proprietary signal processing algorithms. This analysis provides physicians and patients with a detailed assessment of cardiovascular disease (CVD) risk from a single blood test that measures the concentration of low density lipoprotein particles (LDL-P) and other lipoprotein information.
LDL-P is the first FDA-cleared assay on the Vantera Clinical Analyzer and is a key component of LipoScience’s NMR LipoProfile® test. To date, over 9 million NMR LipoProfile tests have been ordered to aid in CVD risk management. Adoption and decentralization of the Vantera Clinical Analyzer into clinical laboratories will ultimately provide widespread access to the NMR LipoProfile test, reduce sample processing turnaround time and provide value to physicians focused on delivering quality patient care and personalized management of cardiovascular disease.
“LDL-P improves the identification of patients at risk for cardiovascular disease risk compared to calculated LDL cholesterol,” said Allan Jaffe, MD, a clinical cardiologist and Professor of Medicine and Laboratory Medicine and Pathology at the Mayo Clinic. Amy Saenger, Ph.D. is the Director of Cardiovascular Laboratory Medicine at Mayo Clinic and stated “We are excited to offer LDL-P and other NMR lipoprotein profiles, enhancing our extensive and expanding cardiovascular disease test menu.” Mayo Medical Laboratories and the Cardiovascular Laboratory will continue their close scientific collaboration with LipoScience to develop new NMR-based assays targeted at improving outcomes for patients with CVD.
“Having Mayo Medical Laboratories offer NMR lipoprotein particle testing within Mayo Clinic and to external physicians is an important milestone as we drive towards widespread adoption and availability of the NMR LipoProfile test, to personalize the management of patients with cardiovascular disease risk,” said Tim Fischer, Chief Operating Officer at LipoScience.
About LipoScience, Inc.
LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary diagnostic test, the NMR LipoProfile® test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 9 million NMR LipoProfile tests have been ordered. LipoScience’s automated clinical analyzer, Vantera®, has been cleared by the FDA. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology through ease of use and walk away automation. The Vantera system will be placed with national and regional clinical laboratories.
LipoScience is driving toward becoming a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of cardiovascular, metabolic and other diseases. For further information on LipoScience, please visit www.liposcience.com.
About Mayo Clinic Department of Laboratory Medicine and Pathology/Mayo Medical Laboratories The Department of Laboratory Medicine and Pathology at Mayo Clinic maintains an active diagnostic test development program, incorporating Mayo Clinic discoveries and expertise with discoveries from other diagnostic and biotechnology companies and leading academic and research organizations. Mayo uses these proven diagnostic technologies to care for its own patients and offers them to more than 5,000 health care institutions around the world through Mayo Medical Laboratories. Revenue from testing is used to support medical education and research at Mayo Clinic. For more information, visit www.MayoMedicalLaboratories.com.
About Mayo Clinic
Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit www.mayoclinic.com and www.mayoclinic.org/news.
Forward Looking Statements
The statements in this press release that are not historical facts constitute "forward-looking statements" that involve risks and uncertainties and are made pursuant to the Private Securities Litigation Reform Act of 1995. These forward-looking statements include expectations regarding the capabilities and availability of the Vantera Clinical Analyzer, LipoScience's collaboration with the Mayo Clinic and the Company's ability to increase and sustain demand for its NMR LipoProfile test, as well as the Company's plans for future diagnostic tests on the Vantera platform. The achievement or success of the matters covered by such forward-looking statements involve risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, the Company's results could differ materially from the results expressed or implied by the forward-looking statements it makes. These risks and uncertainties include, but are not limited to, risks associated with the receptiveness of third-party laboratories with respect to the placement of Vantera Clinical Analyzers at their facilities, the Company's ability to expand its sales and marketing capabilities in order to increase demand for the NMR LipoProfile test and any future tests that it may develop, the Company's ability to compete with other diagnostic testing methods that may be more widely accepted and the Company's ability to secure regulatory clearance by the FDA of the non-cleared portions of the NMR LipoProfile test. Further information on these and other factors that could affect the Company's results is included in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and other filings the Company makes with the Securities and Exchange Commission from time to time. These documents are available on the SEC Filings section of the Investor Relations page of the Company's website at http://investor.liposcience.com. The statements made in this release are based on information available to LipoScience as of the date of this release, and the Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.