Healthcare Industry News: Real-Time PCR
News Release - December 27, 2007
Sequenom Announces New York State Approval of a Noninvasive Prenatal TestLaboratory Developed Test for Rhesus D Incompatibility
SAN DIEGO--(HSMN NewsFeed)--Sequenom, Inc. (NASDAQ:SQNM ) today announced the New York State approval of the first noninvasive prenatal test based on Sequenom’s SEQureDx™ Technology for Cell Free Fetal Nucleic Acid assessment. The Laboratory Developed Test (LDT) performed on a Real-Time PCR (RT-PCR) platform to detect Rhesus D (RhD) incompatibility will be marketed by Sequenom’s nonexclusive licensee, CLIA-certified, New York State Permitted laboratory Lenetix Medical Screening Laboratory, Inc., Mineola, New York.
“This will be the first commercially introduced noninvasive prenatal test in the United States to utilize the SEQureDx™ Technology and represents a significant step in our strategy to build a proprietary global portfolio of noninvasive prenatal products. RhD is our pioneering test and will serve in assisting in preparing us in developing and launching other tests such as FetalXY and Down syndrome,” said Harry Stylli, Ph.D., Sequenom’s President and Chief Executive Officer. “Genetic-based noninvasive prenatal testing could complement and potentially present a paradigm shift from current invasive testing procedures such as amniocentesis. Tests based on our SEQureDx Technology can be performed from a simple maternal blood sample, which could allow obstetric and fetal maternal specialists to successfully intervene early in the pregnancy to improve outcomes.”
The Company expects to introduce additional noninvasive prenatal tests, beginning in the first half of 2008 with a LDT application for FetalXY/Gender Screening, which may assist healthcare providers in the evaluation of high risk pregnancies with familial history of inherited disorders associated with the X chromosome. In addition, the Company expects to migrate the RhD incompatibility and FetalXY/Gender Screening tests to the proprietary MassARRAY® system next year. The MassARRAY system offers unique multiplexing capabilities for complex genetic targets with outstanding sensitivity and precision, an important advantage for the development of additional noninvasive prenatal tests.
“Lenetix Medical Screening Laboratories is pleased to be the first commercial genetic testing company to offer the RhD/SRY to at-risk pregnant women in the United States,” said Leonard H. Kellner, President and CSO of Lenetix. “We have worked diligently over the last year with the regulatory and molecular experts in the New York State Department of Health to bring this innovative, high-quality, noninvasive prenatal assay to the United States. It will be clinically available to all Lenetix’ customers effectively immediately.”
About Fetal Nucleic Acid Technology
Sequenom’s SEQureDxTM Technology is a novel approach to genetic screening. Unlike current standards of harvesting placental tissue cells as is required for chorionic villus, or entering the uterus to sample the amniotic fluid surrounding the baby as is performed with amniocentesis, SEQureDx Technology extracts Fetal Nucleic Acid material safely and comfortably from a simple blood specimen collected from the mother to determine the genetic status of the fetus. This breakthrough suggests that effective screening may be accomplished in the future without the risks associated with disturbing the amniotic fluid that surrounds the baby in the uterus.
About Rhesus D
Rhesus D (RhD) blood group incompatibility between a pregnant woman and her fetus is a significant problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of the newborn. Alloimmunization most frequently occurs when an RhD negative mother is exposed to red blood cells of an RhD positive fetus, producing maternal antibodies against the RhD antigen. Although the pregnancy in which alloimmunization first occurs results in an unaffected child, future children are at substantial risk of anemia and in the worst cases, fetal death. In the U.S. alone, RhD incompatibility occurs in more than 10% of all pregnancies.
Anti-D immunoglobulin is routinely administered to RhD negative women at 28 weeks and after the birth of the child has helped prevent maternal alloimmunization. This prophylactic treatment prevents alloimmunization in 96% of cases. For the remaining 4% of women, approximately 20,000 pregnancies in the U.S. per year, it is important to establish the RhD type of the fetus. This is frequently performed by amniocentesis between weeks 16 and 20 of the pregnancy. If testing shows that the fetus is RhD negative, no further testing is required. If positive, the pregnancy is closely monitored to ensure the health of the baby.
Sequenom is committed to providing the best genomic and genetic analysis products for research and the molecular diagnostic markets. The Company makes available superior solutions for genomic science in biomedical research, livestock and agricultural applications and molecular medicine, as well as for various diagnostic markets, including noninvasive prenatal testing, oncology and infectious diseases. Sequenom’s proprietary MassARRAY system delivers reliable and specific data from complex biological samples and from genetic target materials available only in trace amounts.
Sequenom®, SEQureDxTM, and MassARRAY® are trademarks of Sequenom, Inc.
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 28 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.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the marketing and offering of a Rhesus D incompatibility test, the Company’s plans to build a proprietary global portfolio of noninvasive prenatal products including other tests such as FetalXY and Down syndrome, the potential of genetic-based noninvasive prenatal testing, the impacts of tests based on SEQureDx Technology, the Company’s plans to introduce additional noninvasive prenatal tests and molecular diagnostic tests, and the Company’s plans to build a portfolio of prenatal applications, and planned noninvasive prenatal tests and their impact on standard of care, 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 demand for and market acceptance of the Company’s products, services, and technologies, new technology and product development and commercialization particularly for new technologies such as laboratory developed tests and molecular diagnostics, and particularly noninvasive prenatal laboratory tests and diagnostics, reliance upon the collaborative efforts of other parties, research and development progress, competition, government regulation, obtaining or maintaining regulatory approvals, and other risks detailed from time to time in the Company’s SEC (U.S. Securities and Exchange Commission) filings, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2006 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 the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.