Wednesday September 6, 8:00 am Eastern Time
Press Release
SOURCE: Applied Imaging Corp.
FDA Clears Applied Imaging System for the Detection of Micrometastic Cancer Cells
SANTA CLARA, Calif., Sept. 6 /PRNewswire/ -- Applied Imaging Corp. (Nasdaq: AICX - news) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its MDS(TM) system for detecting micrometastatic cells associated with the spread of cancer. The MDS, a scanning microscopy platform, has been cleared for in vitro diagnostic use as an aid to pathologists in the detection and classification of specific rare cancer cells in bone marrow specimens.
The ability to detect and characterize micrometastatic cancer cells provides the oncologist with important additional information for the selection of the most appropriate treatment for the patient. In particular, the detection of micrometastasis may lead to more aggressive treatment and follow-up than would otherwise be indicated.
According to Jack Goldstein, PhD, Chairman and Chief Executive Officer of Applied Imaging, ``This rapid FDA clearance of the first clinical application for the MDS represents the achievement of a significant milestone for the company. Our clinical data showed that pathologists using the MDS detected 46% more patients with metastatic cells than they detected by unaided microscopic examination. This substantial improvement will allow us to market the MDS system to thousands of cancer centers worldwide, presenting us with a dramatically expanded opportunity for the company's products.''
``We plan to release additional applications that can genetically characterize cancer cells, by taking advantage of the unique ability of the MDS to conduct simultaneous fluorescent and brightfield studies, essential techniques for the automated analysis of DNA and RNA probes,'' added Goldstein.
Applied Imaging Corp., based in Santa Clara, California, is the leading supplier of automated imaging systems utilized in genetics and pathology laboratories for the analysis of chromosomes in cancer and prenatal disorders. The Company is expanding its efforts in scanning and imaging applications in the cancer pathology field. Applied Imaging has installed over 2000 systems in 1000 laboratories in more than 35 countries.
This press release contains forward looking statements as defined in the Private Securities Litigation Reform Act of 1995, regarding, among other matters, the Company's future financial performance as well as its research and development and product development efforts. Forward looking statements address matters that are subject to a number of risks and uncertainties, including the uncertainty of clinical studies and regulatory approvals. Actual results could differ materially from those projected in the forward- looking statement as a result of a number of factors including the failure of the Company to successfully develop and commercialize its micrometastasis or genetic instrument business, and other such factors as set forth in the Company's Form 10-K for the year ended December 31, 1999 as filed with the Securities and Exchange Commission.
For additional information on Applied Imaging via fax, please dial 1-800-PRO-INFO, (732-544-2850 outside of the U.S.), code AICX.
SOURCE: Applied Imaging Corp.
|
Thread abonnieren
