Aprogenex announces FDA to require resubmission of filing for hemoglobin identification product; action will not affect GenSite timelines; resubmission due to incomplete labeling.HOUSTON--(BUSINESS WIRE)--Dec. 8, 1994--Aprogenex Inc. (ASE (Adaptive Server Enterprise) A relational DBMS from Sybase that runs on Windows NT/2000, Linux and a variety of Unix platforms. ASE is a comprehensive and robust data management product with a long history dating back to the late 1980s. :APG) Thursday announced that the U.S. Food and 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. ) will require a resubmission of a previous filing for a product to identify red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells containing fetal hemoglobin due to incomplete labeling, according to Joel Bresser, president and chief executive officer of the company. ``We believe there was a misunderstanding by the FDA of the component's labeling for intended use. This filing is separate from and not essential to the approval of a prenatal genetic testing product, and we may not resubmit Verb 1. resubmit - submit (information) again to a program or automatic system feed back return, render - give back; "render money" it. We believe this matter should have no effect on our timetable for commercialization of the GenSite maternal blood prenatal genetic testing product,'' Bresser said. A Section 510(k) for the fetal hemoglobin messenger RNA test was previously filed in February 1994 as part of a prior regulatory strategy. The filing indicated that the product would be used to identify the presence of fetal hemoglobin. However, the HbF mRNA probe is also a component part of the company's GenSite product. In a letter to the company, the FDA cited labels on the wash solutions that are required to conduct the test. These wash solutions are principally detergents and contained labels not just for use with the fetal hemoglobin test Fetal Hemoglobin Test Definition Fetal hemoglobin (Hemoglobin F), Alkali-resistant hemoglobin, HBF (or Hb F), is the major hemoglobin component in the bloodstream of the fetus. but also for the company's other tests. The FDA expressed a concern that because these wash solutions are used in tests not yet filed with the FDA, the HbF mRNA product could be used in a manner other than that indicated in the product filing. The company believes that such alternative use is not technically possible. Aprogenex develops and intends to manufacture and market 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. probe-based diagnostic test systems based on its proprietary RIGHTechnology patents which are broadly applicable to extensive markets in genetics, oncology, virology and microbiology. The company is in clinical trials with components of its GenSite maternal blood prenatal genetic testing assay and in preclinical development with its PapPlus HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) diagnostic assay and two HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. diagnostic and staging tests, the Virafy and ViraFlow assays. CONTACT: Aprogenex Inc., Houston
J. Donald Payne, 713/748-5114
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Keatinge/Seaton Communications
Richard Keatinge, 619/625-2100
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Lippert/Heilshorn & Associates
Michele Fasano, 212/838-3777
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