Printer Friendly

MICROPROBE RECEIVES PERMISSION TO MARKET ID SYSTEM FOR PERIODONTAL DISEASE-ASSOCIATED ORGANISMS IN 11 COUNTRIES

 BOTHELL, Wash., Jan. 4 /PRNewswire/ -- MicroProbe Corp. today announced that the U.S. Food and Drug Administration granted it permission to export the Affirm(TM) DP Microbial Identification Test System to Australia, Austria, Belgium, Denmark, the Federal Republic of Germany, Greece, Hong Kong, Norway, South Africa, Spain and Switzerland. The company has not received FDA clearance to market the product in the United States. The system represents the first direct DNA-probe test for near-patient detection and identification of microorganisms associated with periodontal disease, the most common cause of tooth loss in adults.
 Meeting the growing demand for in-office identification of the microorganisms associated with periodontal disease, the new test provides the dental practitioner with a timely tool to counsel patients and monitor therapy. Delivering results in less than 40 minutes, the test is designed for use as an adjunct to clinical evaluation for differentiating the bacteria associated with the disease.
 Based on MicroProbe's proprietary technology, the Affirm DP is also the first in-office dental DNA-probe test to simultaneously detect and identify multiple organisms from a single patient sample. The new system can detect and directly identify three bacteria: Porphyromonas gingivalis, Bacteriodes forsythus and Actinobacillus actinomycetemcomitans.
 "The focus of MicroProbe's diagnostics divisions is clearly aimed at the clinical segment of the in vitro test market, said John L. Bishop, chairman and chief executive officer. "At the same time, the flexibility of our DNA-probe technology and test format allows us to leverage our proprietary position and participate in an emerging new market."
 Periodontal Disease
 Periodontal disease afflicts three out of four persons at some point in their life. The main cause of the disorder is bacterial plaque, a sticky, colorless film that constantly forms on the teeth. Toxins produced by bacteria in plaque can irritate gums and ultimately destroy supporting tissues and bone that surround teeth. Periodontitis, a severe form of the disease, causes gum tissue to become red, swollen and bleed easily. If untreated, the condition can lead to irreversible gum damage and tooth loss.
 The Affirm(TM) DP Microbial Identification System
 Offering the advantages of speed, specificity, sensitivity and ease- of-use, the Affirm DP test uses synthetic DNA subunits, called oligonucleotides or DNA probes, designed to bind to genetic material unique to a specific organism. The system consists of a small, easy-to- use automated processor, Probe Analysis Cards (PACs) and reagents. The system's complex chemistry is invisible to the user, who simply loads the sample and reagent cassette into the automated processor, starts the instrument, and reads the test results before the patient leaves the office.
 Utilizing three organism-specific DNA probes attached to a polymer bead format, the system can simultaneously detect and identify three organisms from a single plaque sample taken from below the patient's gum line. Each PAC also includes a negative (specificity) control and positive (procedural) control. With minimal training, the test requires only two minutes of hands-on time. Results are read visually, with blue color on a bead indicative of a positive result, while negative results show no color.
 Recently, the FDA cleared for U.S. marketing MicroProbe's Affirm(TM) VP Microbial Identification System for detecting microorganisms associated with vaginitis. DNA-probe test kits for other obstetric and gynecological diagnostic applications are under development for use in the system.
 MicroProbe Corp. is developing practical applications of oligonucleotides for the diagnosis and treatment of infectious diseases, utilizing proven principals of biochemical control. The company produces DNA probe-based systems for the rapid identification of infectious-disease microorganisms, and is involved in research aimed at the discovery and development of new classes of therapeutics that selectively block genes and disease-causing proteins of chronic viral infections and certain cancers.
 -0- 1/4/93
 /CONTACT: John Bishop, chairman and chief executive officer of MicroProbe, 206-485-8566 or Charles Versaggi of Versaggi & Associates, 408-358-4162, for MicroProbe/


CO: MicroProbe Corporation ST: Washington IN: MTC SU:

TS-SM -- NY009 -- 1160 01/04/93 08:32 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 4, 1993
Words:648
Previous Article:NETWORK WORLD AND LEADING INDUSTRY EXPERTS FORM ALLIANCE FOR REAL-WORLD PRODUCT TESTING
Next Article:LUNAR ANNOUNCES THAT ONE-ALPHA D2 WAS EFFECTIVE
Topics:


Related Articles
MICROPROBE RECEIVES $2.9 MILLION INVESTMENT
MICROPROBE RECEIVES FDA CLEARANCE TO MARKET FIRST MICROBIAL IDENTIFICATION SYSTEM FOR VAGINITIS
MICROPROBE RECEIVES $8 MILLION TO EXPAND PRODUCT DEVELOPMENT AND MARKETING
MICROPROBE RESPONDS TO GEN-PROBE'S PATENT INFRINGEMENT SUIT
MICROPROBE INITIATES COUNTERSUIT AGAINST GEN-PROBE
MICROPROBE NAMES VICE PRESIDENT SALES & MARKETING
AFFIRM VPIII MICROBIAL IDENTIFICATION SYSTEM INTRODUCED BY MICROPROBE: SIMULTANEOUS DETECTION OF 3 VAGINITIS PATHOGENS
MICROPROBE AWARDED NIH GRANT FOR ANTIBIOTIC-RESISTANT TUBERCULOSIS DETECTION PROGRAM
MICROPROBE AND PROCTER & GAMBLE SIGN ORAL CARE PRODUCT AGREEMENT
MICROPROBE AGREES GEN-PROBE PATENTS VALID

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters