HUM-MOLGEN archive: ETHI, DIAG: genetic testing

The following press releases should be considered in the light of the recently posted report of the first meeting of the NIH Task Force on Genetic Testing. My apologies to all for the formatting. Hans Goerl ETHI editor ******************************************************************** Headline: ONCOR, INC. RECEIVES FDA PERMISSION TO EXPORT CANCER TESTS Oncor, Inc. announced today that it has received permission from the U.S. Food and Drug Administration (FDA) to export its investigational in vitro diagnostic genetic test systems for HER-2/neu and Chronic Myelogenous Leukemia (CML) Mbcrlabl to Austria, Switzerland, and Ireland. Applications for permission to export these systems to other European countries are pending. The two in vitro diagnostic test kits completed multi-center clinical investigations and are currently undergoing review for pre- market approval at the FDA. Oncor anticipates an FDA panel review will be scheduled during the fourth quarter of 1995 for its HER-2/neu (ERBB2) Gene Amplification Detection System for the characterization and management of breast cancer. Oncor filed a PMA application with the FDA for the test system in February 1994. Oncor, Inc. (http://www.oncorinc.com/home) develops, manufactures and markets genetic test systems and related products for use in the detection and management of cancer and other human disease. ******************************************************************** Headline: BAYER CORPORATION AND MYRIAD GENETICS ANNOUNCE $71 M Date: Tue, Sep 12, 1995 Bayer Corporation and Myriad Genetics, Inc., today jointly announced a five-year strategic alliance focused on the discovery of genes which predispose individuals to obesity, osteoporosis and asthma. The collaboration will combine Myriad's strengths in gene discovery and gene characterization with Bayer's drug discovery, development and marketing expertise. Myriad received a $10 million equity investment from Bayer and, under the terms of the agreement, will receive $25 million in research payments over the five year period. In addition, Bayer will provide Myriad with up to $36 million in milestone payments for the discovery and characterization of genes related to obesity, osteoporosis and asthma. In exchange for future royalty payments to Myriad, Bayer will receive a worldwide exclusive license to develop and commercialize therapeutic products derived from the collaboration, including small- molecule, protein replacement and gene therapeutics. Myriad will retain worldwide diagnostic rights, including the right to develop and market genetic tests that screen for genes which predispose patients to obesity, osteoporosis and asthma. "Our alliance with Myriad is a key component of our efforts to utilize molecular genetics in Bayer's pharmaceutical discovery program. Myriad has developed an impressive set of technologies for genetic discovery and is a leader in locating and sequencing important disease- related genes," said Horst Wallrabe, Executive Vice President, Bayer Corporation and President of Bayer's Pharmaceutical Division. "We look forward to collaborating with Myriad and pursuing the development of important and innovative therapies." Molecular genetics involves isolating genes and identifying the genetic mutations involved in predisposing individuals to a particular disorder. Understanding the genetic basis of disease may provide critical tools for analyzing the molecular pathways in the disease process, and helps define new targets against which innovative therapies can be designed. Peter D. Meldrum, President and CEO of Myriad, commented: "Bayer is a leader in the development and marketing of pharmaceutical products for metabolic and respiratory disorders. Bayer's participation in this agreement underscores our strength in gene discovery and the potential for advancing drug discovery using Myriad's technologies. Our collaboration with Bayer furthers Myriad's strategy of capitalizing on strategic alliances to develop therapeutic products based on our gene discoveries while retaining exclusive rights to commercialize genetic testing products and services." (MATERIALDELETED) Myriad Genetics, Inc., based in Salt Lake City, Utah, is a gene discovery and genetic testing company focused on the discovery and commercialization of genes involved in major common disorders, including cancer, heart disease, obesity, osteoporosis and asthma. Myriad is currently establishing a genetic testing and information business through its wholly owned subsidiary, Myriad Genetic Laboratories, Inc. In order to accelerate its gene discovery programs, Myriad employs two synergistic sets of technologies: the genetic analysis of large families performed by Myriad's scientists and collaborators; and Myriad's advanced, proprietary gene mapping, sequencing and cloning technologies. This combined approach provides an unparalleled resource in the gene discovery process and allows for the rapid discovery of important disease-causing genes, as well as the characterization of harmful mutations in those genes. Using this strategy, Myriad has made several major genetic discoveries during the last 18 months, including the BRCA1 breast and ovarian cancer gene and the role of the MTS1 gene in many cancer types. The Company intends to commercialize its gene discoveries by providing genetic tests for individuals to determine whether or not they have inherited gene mutations which may increase their risk for specific diseases. Myriad has developed a highly automated genetic testing platform which the Company believes will enable it, once it has discovered and sequenced a gene, to develop a test for genetic predisposition relatively quickly and economically. The Company believes that the information gained from the tests that confirm genetic predisposition has potential value to individuals and their health care providers in the following areas: (i) proactive health care and lifestyle decisions that may delay or prevent the onset of disease; (ii) early detection of disease; and (iii) selection of the most appropriate treatment.