Roche Diagnostics First Company to Receive U.S. Clearance and European CE Mark for Two New Thrombophilia Genetic Disorder Tests.Business Editors/Health/Medical Writers BASEL, Switzerland--(BUSINESS WIRE)--Dec. 18, 2003 Real-Time PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) Tests Are the First in Vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. Diagnostic Products on Roche's LightCycler(R) Instrument Roche Diagnostics today announced the launch of its new Factor V Leiden factor V Leiden Hematology A variant of factor V present in 3%-8% of Caucasians associated with a ↑ risk of DVT. See LETS, Hereditary thrombophilia. Kit and Factor II (Prothrombin prothrombin Carbohydrate-protein compound in plasma essential to coagulation. In response to bleeding, a complex series of clotting-factor interactions leads to its conversion by thromboplastin to thrombin, which transforms fibrinogen in plasma into fibrin. ) G20210A Kit for its LightCycler(R) real-time PCR instrument. Both tests allow the detection and genotyping of inherited mutations in the genes that encode the Factor II and Factor V proteins, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. Inherited thrombophilia predisposes an individual to thrombotic events such as venous thrombosis, the third most common cardiovascular disease. The kits received 510(k) clearance under an accelerated review/de novo process from the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) this week, and also bear the CE Mark, which expresses conformity with the requirements of the European IVD (Interactive VideoDisc) See interactive video. Directive and allows distribution within the European Union. The tests are now available in Europe for commercial sales and will be available for commercial sale in the U.S. in early 2004. "Creating the first FDA-cleared human DNA-based genetic disorder tests demonstrates the leadership of Roche in molecular diagnostics, and is symbolic of the developments Roche Diagnostics continues to achieve on this 20th anniversary of PCR. The clearance for these types of tests increases access to genetic testing technology important for today's blood clotting mutation identification, and opens the door to future advances using Roche's MagNA Pure and LightCycler products," said Heino von Prondzynski, Head of Roche Diagnostics and Member of the Roche Executive Committee. The two in vitro diagnostic tests have been specifically developed for real-time PCR using Roche's LightCycler instrument. Both kits were initially introduced to the market as RUO RUO Research Use Only RUO Reference Unbundling Offer RUO Run Ultima Online (emulator program) RUO Resident Unit Officer (research use only) products in 1999. The components of the kits are designed to maximize test performance with minimal handling steps. The American College of Medical Genetics The American College of Medical Genetics (ACMG) is an organization composed of biochemical, clinical, cytogenetic, medical and molecular geneticists, genetic counselors and other health care professionals committed to the practice of medical genetics. and the College of American Pathologists This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. have issued consensus statements recommending measurement of heritable her·i·ta·ble adj. 1. Capable of being passed from one generation to the next; hereditary. 2. Capable of inheriting or taking by inheritance. thrombophilic risk factors, such as Factor V Leiden and Prothrombin G20210A in patients with suspected thrombophilia. About the LightCycler Instrument and New IVD Tests The LightCycler instrument combines an innovative thermal cycler platform with a fluorescence detection system. With proven performance in the research market for over five years, the instrument combines rapid-cycle PCR with real-time fluorescence monitoring. The IVD kits provide primer, hybridization probes for sequence-specific detection and determination of the genotype, pre-mixed reagents, a control template and PCR grade water. Only patient sample DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. has to be added. These kits are designed for 32 reactions and a maximum of 30 samples. For preparation of human genomic DNA from whole peripheral blood, automated nucleic acid purification can be performed using the MagNA Pure LC Instrument in combination with the MagNA Pure LC DNA Isolation Kit I. Alternatively, a manual method employing the High Pure PCR Template Preparation Kit can be used. About Roche and Roche Diagnostics Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology virology, study of viruses and their role in disease. Many viruses, such as animal RNA viruses and viruses that infect bacteria, or bacteriophages, have become useful laboratory tools in genetic studies and in work on the cellular metabolic control of gene expression and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide. LightCycler is a registered trademark of a member of the Roche Group. MagNA Pure and High Pure are trademarks of a member of the Roche Group. Please register for our convenient "NewsFlash" service in our online "Press Lounge" See our Website "www.roche-diagnostics.com" |
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