Noninvasive Prenatal Diagnostics - How Will They Revolutionize the Industry?DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c48236) has announced the addition of Noninvasive Prenatal Diagnostics: How Will They Revolutionize the Industry? to their offering. Prenatal diagnostics have been used since the 1960s to help determine the health of a fetus in its mother's womb. A key use of prenatal diagnostics is found in the diagnosis of infectious disease, such as group B streptococcus group B streptococcus Streptococcus agalactiae A streptococcus classified into 7 capsular serotypes, which is the leading cause of sepsis and meningitis in neonates; GBS affects 1. . Timely diagnosis and treatment of the infection can prevent preterm delivery and lower overall health care costs. The trend in prenatal diagnostics is moving away from invasive procedures, which reveal genetic abnormalities but can harm the mother and the fetus, toward noninvasive procedures. Questions Answered in This Spectrum Report Current invasive prenatal diagnostics such as amniocentesis and chorionic villus sampling chorionic villus sampling (CVS) or chorionic villus biopsy (CVB) (kōr'ē-ŏn`ĭk, kôr'–), diagnostic procedure in which a sample of chorionic villi from the developing placenta is removed from the (CVS (1) (Concurrent Versions System) A version control system for Unix that was initially developed as a series of shell scripts in the mid-1980s. CVS maintains the changes between one source code version and another and stores all the changes in one file. ) can definitively detect chromosomal abnormalities, but these procedures are costly and risky. What noninvasive techniques are gradually taking the place of amniocentesis and CVS? A movement is under way within the medical community to shift more prenatal testing to the first trimester for earlier diagnosis. What are the benefits of earlier testing? In order for new prenatal diagnostic products to be competitive in the prenatal care market, they must have four attributes. What are they? Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a ) laboratories are important to companies with noninvasive prenatal diagnostics in development. What key role do they play? Numerous companies are working on molecular techniques such as DNA microarrays, polymerase chain reaction polymerase chain reaction (pŏl`ĭmərās') (PCR), laboratory process in which a particular DNA segment from a mixture of DNA chains is rapidly replicated, producing a large, readily analyzed sample of a piece of DNA; the process is (PCR), fluorescence in situ hybridization Fluorescence in situ hybridization (FISH) A technique for diagnosing DiGeorge syndrome before birth by analyzing cells obtained by amniocentesis with DNA probes. FISH is about 95% accurate. (FISH), and mass spectrometry (MS) to evaluate maternal blood and urine samples. Which companies will have an impact on the market? Scope Invasive prenatal procedures: amniocentesis, CVS, percutaneous umbilical blood sampling percutaneous umbilical blood sampling PUBS Cordocentesis Neonatology An ultrasound-guided needle aspiration of umbilical cord blood, to ID fetal disease–eg, hemoglobinopathies, hemophilia, autoimmune thrombocytopenia, von Willebrand disease, (PUBS). Current noninvasive procedures: ultrasound and maternal serum testing. Noninvasive procedures under development: cellular techniques, molecular techniques, novel biomarkers. Key players in noninvasive prenatal diagnostics: companies developing products to prevent preterm labor and companies developing products to detect genetic abnormalities. Content Outline: Executive Summary Strategic Considerations Stakeholder Implications Overview Invasive Procedures Noninvasive Procedures Trend Toward Earlier Testing Commercial Opportunities in Noninvasive Testing Current Prenatal Diagnostics Invasive Techniques Noninvasive Techniques Assessing Chromosome Abnormalities Assessing Preterm Delivery Risks New Technologies for Noninvasive Prenatal Diagnostics Detection of Fetal DNA from Maternal Blood Cellular Techniques Molecular Techniques Novel Biomarkers for Preterm Delivery Key Players in Noninvasive Prenatal Technologies Noninvasive Preterm Labor Diagnostics Adeza Biomedical Sidebar: What Are the CLIA? Cepheid Proteogenix Noninvasive Prenatal Genetic Diagnostics Sequenom Biocept Laboratories Ikonisys Xenomics PerkinElmer Life and Analytical Sciences Osmetech Molecular Diagnostics BTG Plasmagene plas·ma·gene n. A self-replicating hereditary structure thought to exist in cytoplasm and function in a manner analogous to, but independent of, chromosomal genes. Biosciences Signature Genomic Laboratories Ravgen Parsortix Aviva Biosciences Outlook Future Holds Promise for Noninvasive Prenatal Diagnostics Proof of Changing Paradigm in Managing Prenatal Diagnosis Tables 1. Prenatal Diagnostic Tests Commonly Used in the United States, by Gestational Age, 2006 2. Current Noninvasive First- and Second-Trimester Screening Tests for Select Abnormalties, 2006 3. New Prenatal Molecular Diagnostic Techniques 4. Key Players in Novel Noninvasive Prenatal Diagnostics for Detection of Preterm Delivery 5. Key Players in Novel Noninvasive Prenatal Diagnostics for Genetic Analysis 6. New Noninvasive Diagnostic Products--Potential Impact on Prenatal Market Figures 1. Developers of Novel Noninvasive Prenatal Diagnostic Products and the Products' Potential Market Impact Companies Mentioned: Abbott Laboratories Adeza Biomedical Adeza Diagnostic Services Aviva Biosciences Baylor College of Medicine Baylor College of Medicine is a private medical school located in Houston, Texas, USA on the grounds of the Texas Medical Center. It has been consistently rated the top medical school in Texas and among the best in the United States. Biocept Laboratories Bruker Daltonics BTG Cepheid Daiichi Pure Chemicals Diagnostic Systems Laboratories Diagnostic Technologies Eastern Virginia Medical School Eastern Virginia Medical School, in Norfolk, Virginia is a public medical school. Ikonisys Illumina Isis Innovation Jacobi Medical Center JN Macri Technologies NeoGenomics North Shore-Long Island Jewish Health System NTD Laboratories Oregon Health & Science University Osmetech Molecular Diagnostics Parsortix PerkinElmer Life and Analytical Sciences Pilgrim Software Plasmagene Biosciences Proteogenix Qiagen Quest Diagnostics Ravgen Sequenom Siemens Medical Solutions Siemens Medical Solutions (Siemens Med) is a supplier to the healthcare industry, and is headquartered in Erlangen, Germany. Its U.S. division, Siemens Medical Solutions USA, Inc., is a Delaware corporation, with headquarters in Malvern, Pennsylvania. Signature Genomic Laboratories Spallanzani National Institute of Infectious Diseases Spectral Genomics University of Copenhagen The University of Copenhagen (Danish: Københavns Universitet) is the oldest and largest university and research institution in Denmark. University of Leicester History The University was founded as Leicestershire and Rutland College in 1918. The site for the University was donated by a local textile manufacturer, Thomas Fielding Johnson, in order to create a living memorial for those who lost their lives in World War I. World Health Organization Xenomics For more information visit http://www.researchandmarkets.com/reports/c48236 Source: Decision Resources |
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