Printer Friendly

ALAMAR BIOSCIENCES LAUNCHES PRODUCT LINE AFTER FDA CLEARANCE OF GRAM NEGATIVE BACTERIA ID TEST

 SACRAMENTO, Calif., Oct. 5 /PRNewswire/ -- Alamar Biosciences Inc. (NASDAQ: ALMR) today announced that it has received marketing clearance from the U.S. Food and Drug Administration for the gram negative portion of its bacterial identification test kit. This clearance will enable Alamar to launch a substantial portion of its product line of manual and semi-automated diagnostic tests.
 Kenneth D. Miller, chief executive officer of Alamar, said, "We are very pleased to have received clearance for the gram negative bacterial ID test kit. Gram negative bacteria tests represent over 55 percent of all specimens in a typical microbiology laboratory and sales of gram negative ID tests account for an even larger portion of the ID test kit market. With this clearance, we are ready to launch a product line of test kits that identify gram negative bacteria and the dosage of gram negative and gram positive antibiotics
effective in treating bacterial infections." Miller estimates the market potential for U.S. commercial gram negative identification kits at $50 million annually.
 Alamar had originally attempted to obtain clearance for a combined gram negative/gram positive ID test kit. As part of securing the clearance for gram negative ID, however, the company temporarily withdrew its 510k application for gram positive ID. "The FDA had additional questions regarding the gram positive portion of the application," Miller said. "Since that portion represents only 14 percent of all U.S. commercial sales, or under $20 million of the market, we opted to separate the two in order to expedite the more important gram negative clearance."
 According to Miller, gram positive identification testing is done mostly by "spot" tests or very basic chemical tests, representing only 30 percent of typical laboratory specimens. The remaining 15 percent of laboratory specimens, including yeast, anaerobes, parasites and other pathogens, are not tested with these ID kits. Miller said the company is reviewing the gram positive application and anticipates refiling the application sometime in the future.
 "The clearance of the gram negative identification is great news which will enable our U.S. sales force to begin marketing efforts with an attractive portfolio of products that provide a cost effective and customized testing format," Miller said. The company's complete product line continues to be available internationally.
 Addition of the manual gram negative identification test kit to the FDA cleared gram negative and gram positive MIC susceptibility test kits and READar(TM) instrument that interprets test results, will allow Alamar to actively pursue two-thirds of the $530 million market. Alamar presently has a 510k application for using the READar instrument to interpret the gram negative ID tests. The company expects this clearance in the near future.
 Common stock in Alamar Biosciences Inc. is traded on NASDAQ under the symbol ALMR. The company develops, manufactures, and markets in vitro (outside the body) testing products for hospitals, reference laboratories and other health care providers. Alamar markets alamarBlue(TM), an indicator dye for determining cell viability in research and biotechnology applications.
 For information on Alamar Biosciences Inc. by FAX, dial 1-800-PRO-INFO, extension 141.
 -0- 10/5/93
 /CONTACT: Kenn Miller of Alamar Biosciences, 916-567-3475; or Elizabeth Truax or Lillian Armstrong, 415-986-1591, of Financial Relations Board for Alamar/
 (ALMR)


CO: Alamar Biosciences Inc. ST: California IN: MTC SU: PDT

PK -- SF003 -- 8718 10/05/93 09:03 EDT
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:Oct 5, 1993
Words:550
Previous Article:CITATION INSURANCE GROUP AND MADISON CAPITAL MERGER COMPLETED
Next Article:U.S. COURT OF APPEALS, FOURTH CIRCUIT, REVERSES $22 MILLION JUDGMENT AGAINST BLUE CROSS & BLUE SHIELD OF OHIO
Topics:

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