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MICROPROBE RECEIVES FDA CLEARANCE TO MARKET FIRST MICROBIAL IDENTIFICATION SYSTEM FOR VAGINITIS

MICROPROBE RECEIVES FDA CLEARANCE TO MARKET FIRST MICROBIAL IDENTIFICATION
 SYSTEM FOR VAGINITIS
 BOTHELL, Wash., Oct. 1 /PRNewswire/ -- MicroProbe Corp., based here, today announced that the U.S. Food and Drug Administration granted the company clearance to market the Affirm VP Microbial Identification System, the first direct DNA-probe test for near-patient diagnosis of vaginitis, a condition responsible for more than 10 million physician office visits annually for symptomatic women.
 MicroProbe's FDA clearance is also the first for a DNA probe system that simultaneously detects and identifies multiple organisms from a single patient sample. As an adjunct to clinical evaluation for differentiating trichomoniasis and bacterial vaginosis, the Affirm VP test system will be available for use in the physician's office for the qualitative detection and direct identification of the protozoan, Trichomonas vaginalis, and the bacterium, Gardnerella vaginalis, in vaginal samples. Recent studies have linked the presence of these microorganisms with vaginal infections that may be a risk factor for pre-term delivery, post-operative and post-partum infections leading to pelvic inflammatory disease.
 "More than a key product milestone for MicroProbe, FDA clearance of the Affirm VP system brings the full power and benefit of DNA-probe technology to near-patient testing markets," said John L. Bishop, MicroProbe's chairman and chief executive officer. "With the growing problem of mixed vaginal infections, the Affirm VP provides the physician with an important diagnostic adjunct where complex signs and symptoms often mask co-existing conditions, including potentially more serious sexually transmitted diseases."
 According to Kenneth L. Melmon, M.D., associate chairman of the department of medicine at Stanford University and a member of MicroProbe's scientific advisory board, the Affirm VP answers the OB/GYN community's need for a practical and specific diagnostic test that should enable more specific treatment. "The physician requires the timely identification of the disease-causing pathogens to decide the best and most specific course of treatment prior to initiating therapy - - especially within the time frame of a patient's visit to the doctor's office."
 Offering the advantages of speed, specificity, sensitivity and ease- of-use, the Affirm VP test is the first of a series of infectious- disease tests designed specifically for the physician's-office or near- patient clinical setting -- a major segment of the in vitro diagnostics market. Based on MicroProbe's DNA probe technology, the Affirm VP uses synthetic DNA subunits, called oligonucleotides or DNA probes, designed to bind to DNA unique to a specific organism. The system consists of a small, easy-to-use processor, Probe Analysis Cards, a sample-collection device and reagents.
 Utilizing two organism-specific DNA probes attached to a polymer bead format, the system can simultaneously detect and identify both organisms from a single vaginal swab. Each Probe Analysis Card also includes a specificity (negative) control and procedural (positive) control. With minimal training, the test requires only two minutes of hands-on time and an automated processing procedure of about 30 minutes. Results are read visually, with blue color on a bead indicative of a positive result, while negative results show no color.
 The Affirm VP will be available directly through MicroProbe or its certified distributors at a cost of approximately $16 per test panel. DNA probes for other OB/GYN diagnostic applications are also under development for use with the system.
 MicroProbe Corp. is developing practical applications of oligonucleotides for the diagnosis and treatment of infectious diseases. Applying proven principals of biochemical control to oligonucleotides, the company designs and manufactures automated DNA probe-based systems for the rapid identification of infectious-disease microorganisms. MicroProbe is also utilizing this advanced approach toward the development of Antigene drugs, a new class of therapeutics that selectively block genes responsible for disease-causing proteins.
 -0- 10/01/92
 CONTACT: John Bishop, chairman and chief executive officer of MicroProbe Corp., 206-485-8566 CO: MICROPROBE CORP. IN: HEA ST: WA -- SJTH001 -- X899 10/01/92
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Date:Oct 1, 1992
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