Printer Friendly
The Free Library
5,668,249 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Clinical Data Receives FDA 510K Clearance for the New Excyte(TM) Hematology Analyzer.


NEWTON, Mass. -- Clinical Data, Inc.,(NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CLDA) announced today that the Company has received FDA 510K clearance for a new hematology analyzer, the Excyte Pro-Diff 5. Clinical Data will be distributing the analyzer and consumables under an exclusive distribution agreement for North America with Melet Schloesing Laboratoires International, S.A. of Cergy-Pontoise, France, the developer of the instrument. Clinical Data also announced that product launch will begin immediately.

Differential cell counting is used to diagnose such conditions as anemia, infections, allergic reactions and platelet disorders. Millions of such tests are performed daily in hospitals and doctors' offices worldwide. Clinical Data estimates the annual market for hematology analyzers to be over $670 million in the U.S. and over $1.7 billion globally.

The Excyte Pro-Diff 5 is a fully-automated device used to count 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 
, white blood cells White blood cells
A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system.

Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies
, platelets, measure hemoglobin and calculate or measure several red cell indices red cell indices A group of values obtained from automated blood cell counters that provide information about size–ie, volume and concentration of Hb in RBCs; 3 abbreviations are found on the printouts of CBCs: MCH, MCHC, MCV

, including erythrocyte mean corpuscular volume mean corpuscular volume
n. Abbr. MCV
The average volume of red blood cells in erythrocyte indices, calculated from the hematocrit and the red blood cell count.
, mean corpuscular hemoglobin Mean corpuscular hemoglobin (MCH)
A measurement of the average weight of hemoglobin in a red blood cell.

Mentioned in: Red Blood Cell Indices
, and the mean corpuscular hemoglobin concentration Mean corpuscular hemoglobin concentration (MCHC)
The measurement of the average concentration of hemoglobin in a red blood cell.

Mentioned in: Red Blood Cell Indices
. The analyzer performs a differential cell count by classifying the individual white cell components into subpopulations of lymphocytes, granulocytes Granulocytes
White blood cells.

Mentioned in: Blood Donation and Registry

granulocytes (granˑ·y
, eosinophils Eosinophils
A leukocyte with coarse, round granules present.

Mentioned in: Histiocytosis X

eosinophils
, basophils, and monocytes monocytes,
n.pl the largest of the white blood cells. They have one nucleus and a large amount of grayish-blue cytoplasm. Develop into macrophages and both consume foreign material and alert T cells to its presence.
 through electronic sizing. The uniqueness of Melet Schloesing's proprietary technology is that it allows a 5-part differential cell count to be measured for the same cost as conventional 3-part differential analyzers in use today. The analyzer and consumables are to be distributed under the Clinical Data brand name.

Jim Mulry, Director of Hematology Marketing at Clinical Data, commented, "The competitively priced Excyte Pro-Diff 5 Analyzer, with sample auto-loading capability, is designed to meet the needs of the clinical laboratory in providing a complete blood count and a quantitative five-part leukocyte analysis. It is particularly well suited for the physician's office lab. This new hematology analyzer complements the family of diagnostic products now offered by our Clinical Data."

Francois Melet, Founder and President of Melet Schloesing Laboratoires International, S.A. stated, "We are very pleased to have obtained FDA clearance for our technology which we believe has a marked competitive advantage. We look forward to working closely with Clinical Data to insure the success of this collaborative venture."

Clinical Data, through its domestic and foreign subsidiaries, focuses on the needs of physician offices and smaller clinical laboratories. The Company promotes a complete range of products and services for the growing physician office laboratory market including blood chemistry and diagnostic assays to clinics and hospitals throughout the world.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  OF 1995

This press release contains certain forward-looking information about Clinical Data that are intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are further urged to review Clinical Data's various SEC reports, including but not limited to our Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and the Company's 2004 and 2005 quarterly reports on Form 10-QSB.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Aug 8, 2005
Words:617
Previous Article:Sonus Pharmaceuticals Updates Corporate Progress and Reports Second Quarter Financial Results; Company Continuing to Advance TOCOSOL(R) Paclitaxel...
Next Article:Optimal Group Announces Second Quarter 2005 Results; $8.7 million in Underlying Earnings for the Quarter.
Topics:



Related Articles
Enhancing efficiency: step by step. (medical law)
APPLIED BIOSYSTEMS/BRAZILIAN NMH SIGN PACT FOR GENOTYPING.
IGENEON AND IMMUNICON FORM DEVELOPMENT ALLIANCE.
James Mulry Appointed Director of Marketing, Hematology.
ABMC Receives FDA Clearance on Its Rapid Reader; Clearance is the First for an All-Inclusive Drug Screen Interpretation & Data Management System.
Clinical Data Reports Profitable First Quarter.
Clinical Data Summarizes Progress and Achievements and Updates Strategy and Milestones; Company Successfully Integrating Molecular Services Assets,...
Corgenix Submits FDA Premarket Notification of AspirinWorks(R) Test Kit; New Diagnostic Product to Be Used in Assessing Aspirin Effectiveness.
Clinical Data Launches Excyte 20 Automated ESR Analyzer at AACC 2006 Annual Meeting and Clinical Lab Exposition.
Clinical Data's Vital Diagnostics Division Executes Distribution Agreement with Canada's Inter Medico to Sell Excyte Line of ESR Analyzers.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles