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Lenetix Reports Submission of Clinical Data to New York State Authorities for the Commercial Launch of Non-Invasive Prenatal Rhesus D Incompatibility Test
Source: Business Wire
Posted on: Thursday, 28 June 2007, 06:00 CDT
Launch of Non-Invasive Prenatal Rhesus D Incompatibility Test
Sequenom, Inc. (NASDAQ:SQNM) and Lenetix Medical Screening Laboratory, Inc., a provider of rapid genetic screening and diagnostic testing for clinicians worldwide, today announced that Lenetix has submitted a clinical package to the New York State Department of Health to support its application for a clinical laboratory permit to perform a non-invasive prenatal Rhesus D (RhD) incompatibility test, the first non-invasive prenatal test based on Sequenom's Fetal Nucleic Acid Technology. The prenatal RhD incompatibility test will be marketed as a "home brew" and performed on a real-time PCR (RT-PCR) platform. In preparation for New York State approval, Lenetix is preparing marketing and scientific materials to commercialize the RhD incompatibility test throughout the United States.
Lenetix's RhD application of Sequenom's proprietary Fetal Nucleic Acid Technology detects a fetus' RhD status from the mother's blood sample without invasive procedures that typically pose risk to the health of the mother and baby in utero. Approximately 420,000 pregnancies annually in the United States involve mothers who are serologically RhD negative. An RhD positive fetus carried by an RhD negative mother has the risk of developing hemolytic disease. Stratifying pregnancies from low risk to high risk, which have a greater potential for serious disease and the occurrence of death in some rare cases, currently requires careful medical evaluation, antibody testing, immunization and often amniocentesis, an invasive procedure used to confirm RhD status of the fetus. Use of Lenetix's non-invasive fetal RhD incompatibility test for both low and high risk patients may significantly reduce the need for invasive procedures and immunizations.
About Lenetix
Founded in 2001, Mineola, N.Y.-based Lenetix is a privately owned provider of innovative technologies focused on diagnostic testing, including prenatal diagnostics, and risk assessment for genetic disease. Lenetix brings more than 27 years experience developing new and innovative tests that are used by clinicians worldwide. The scientific team at Lenetix is well known for its ability to commercialize new technologies. It is recognized for its translational clinical research and integration of high quality clinical laboratory genetics services within medical centers, universities, and the private sector.
About Sequenom
Sequenom is committed to providing the best genetic analysis products that translate genomic science into superior solutions for biomedical research, molecular medicine, agricultural applications, and non-invasive prenatal testing. The Company's proprietary MassARRAY® system is a high-performance DNA analysis platform that efficiently and precisely measures the amount of genetic target material and variations therein. The system is able to deliver reliable and specific data from complex biological samples and from genetic target material that is only available in trace amounts. The Company has exclusively licensed intellectual property rights for the development and commercialization of non-invasive prenatal genetic tests for use with the MassARRAY system and other platforms.
Sequenom® and MassARRAY® are trademarks of SEQUENOM, Inc.
Except for the historical information contained in this press release, the matters set forth herein, including statements regarding the expected commercial launch, marketing, and performance of a non-invasive fetal Rhesus D test, expected approval of Lenetix's application to the New York State Department of Health, the expected significant reduction in the need for invasive procedures and immunizations by using Lenetix's test, and Sequenom's plans to develop and commercialize prenatal genetic tests for use with its systems or other platforms are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, as amended. 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 reliance upon the efforts of Lenetix, new technology development, product development and commercialization, competition, government regulation, obtaining or maintaining regulatory approvals, market acceptance of the Rhesus D test, Sequenom's technologies, 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, 2006, Sequenom's most recently filed quarterly report on Form 10-Q, and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission (SEC). These forward-looking statements are based on current information that is likely to change. 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.
CONTACT:Â
LENETIX® Medical Screening Laboratory, Inc.Â
Leonard Kellner, President,
516-248-0036Â
www.lenetix.com
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