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Clinical Data Summarizes Progress and Achievements and Updates Strategy and Milestones; Company Successfully Integrating Molecular Services Assets, Committed to Expanding All Divisions, Sees Continuing Significant Market Opportunity.


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 CLDA California Lyme Disease Association ), a worldwide leader in commercializing pharmacogenomics to guide drug utilization, today reviewed recent achievements and is providing an update on strategy and anticipated operational milestones.

In 2005, Clinical Data completed a number of acquisitions that significantly enhanced the Company's breadth and depth of services provided to customers. In the process, the Company evolved from being solely a traditional diagnostics company providing lab equipment, reagents and support services support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other services  to medium-size physician practices and smaller laboratories worldwide, to gaining a leadership position in molecular and pharmacogenomics services. The Company is also leveraging its extensive capabilities to develop Therapeutic Diagnostics(TM) that improve the efficacy and safety of drugs in development and optimize the use of therapeutics in specific patient populations. On a dual track, Clinical Data continues to expand its products and services in its Vital Diagnostics division, its diagnostics business.

Key Achievements - Vital Diagnostics

--Acquired Electa Lab s.r.l. in December 2005 in an all-cash transaction valued at $1.8 million. Electa Lab, headquartered in Forli, Italy, is a leading worldwide supplier of Erythrocyte Sedimentation Rate Erythrocyte Sedimentation Rate Definition

The erythrocyte sedimentation rate (ESR), or sedimentation rate (sed rate), is a measure of the settling of red blood cells in a tube of blood during one hour.
 ("ESR ESR - Eric S. Raymond ") instrumentation and related consumables with annual sales of more than $3 million. Electa Lab has also developed proprietary technology for the safe decapping of blood collection tubes and is developing instruments and assays for the immunochemistry Immunochemistry

A discipline concerned both with the structure of antibody (immunoglobulin) molecules and with their ability to bind an apparently limitless number of diverse chemical structures (antigens); with the structure, organization, and rearrangement
 and coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or  markets, areas highly complementary in nature to the diagnostic products already offered by Clinical Data's domestic and international subsidiaries;

--Obtained exclusive distribution rights in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and Canada for a unique line of hematology analyzers and reagents developed by Melet Schloesing Laboratories that includes four fully automated differential blood cell analyzers for the human diagnostics market. Under the terms of this arrangement, Clinical Data may exclusively manufacture reagents for the analyzers. In August 2005, the Company announced that it received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 510(k) market clearance for the Excyte Pro-Diff 5 ("pro-Diff") hematology analyzer. Product launch occurred shortly after FDA clearance was received. In Q3, 2005, the Company shipped in excess of $100,000 worth of equipment to customers;

--Launched the Envoy 500 benchtop chemistry analyzer in August 2005 leading to the highest quarterly equipment revenues achieved in the past 2 years;

--Upgraded a majority of ESR analyzers to new (Electalab) ESR technology ESR Technology was formerly the Engineering, Safety and Risk business of AEA Technology, which was formed from the commercial arm of the United Kingdom Atomic Energy Authority. It specialises in the provision of independent technical expertise, products and services to help customers: .

Key Achievements -Molecular and Pharmacogenomics Services

--Acquired Genaissance Pharmaceuticals in October 2005 in an all-stock transaction valued at approximately $56 million. Genaissance is a leader in the promising areas of pharmacogenomics and molecular services. This acquisition provides a robust business in the target identification and drug development services markets focused on pharmaceutical, biotechnology, academia and government clients. The acquisition also launches Clinical Data into the clinical diagnostics market with unique Therapeutic Diagnostics driven by genetic marker genetic marker
n.
A gene phenotypically associated with a particular, easily identified trait and used to identify an individual or cell carrying that gene.
 discovery. Genaissance already has tests in the cardiovascular area with tests anticipated soon in CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
;

--Acquired Icoria in December 2005 in an all-stock transaction valued at approximately $12.5 million. Icoria brings a valuable biomarker discovery Biomarker discovery is the process by which biomarkers are discovered. It is a medical term.

Many commonly used blood tests in medicine are biomarkers. The way that these tests have been found can be seen as biomarker discovery.
 platform as well as leading metabolomics and gene expression capabilities that complement the Company's molecular services and pharmacogenomics capabilities. Icoria also strengthens Clinical Data's position in RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 services and molecular profiling;

--Received FDA approval in January 2006 for a pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  study of Vilazodone, a novel compound being studied for treatment of depression. Clinical Data is now embarked on initiating the Phase III trial and parallel response biomarker discovery;

--Signed deals with Organon or·ga·non or or·ga·num
n. pl. or·ga·nons or or·ga·nums or or·ga·na
1. An organ.

2. A set of principles for use in scientific investigation.



organon

pl. organa [Gr.] organ.
, Otsuka and Sankyo to apply our know-how in biomarker development;

--Accelerated validation of the CARING(TM) test development program that the Company expects will lead to the identification of biomarkers for clozapine-induced agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired. ;

--Added Affymetrix based services that will enable our customers to access gene expression and whole genome array capabilities in a GLP-compliant environment;

--Achieved significant growth in the adoption of the FAMILION(R) test, the Company's proprietary test for cardiac channelopathies including familial long QT and Brugada syndromes. The Company also signed its first deal with a pharmaceutical partner to utilize FAMILION in its clinical trials;

--Received an NIAAA NIAAA National Institute on Alcohol Abuse and Alcoholism (National Institutes of Health)
NIAAA National Interscholastic Athletic Administrators Association
NIAAA Northwestern Illinois Area Agency on Aging
 Second Phase SBIR SBIR Small Business Innovation Research (program/grant)
SBIR Space Based Infra-Red
SBIR Speaker-Boundary Interference
SBIR Site Backsurface-referenced Ideal Plane/Range (silicon wafers) 
 contract for alcohol-induced injury biomarkers; three microarray services contracts for up to $1.1 million in revenue over 1-4 years for our microarray laboratory services unit; an NIEHS NIEHS National Institute of Environmental Health Sciences (NIH, DHHS)  Second Phase SBIR $1.2 million for drug-induced liver injury; and a collaborative research agreement with the U.S. Army Edgewood Chemical Biological Center to participate in a study on chemical warfare chemical warfare, employment in war of incendiaries, poison gases, and other chemical substances. Ancient armies attacking or defending fortified cities threw burning oil and fireballs. A primitive type of flamethrower was employed as early as the 5th cent. B.C.  agent detection.

Other Significant Achievements

--Successfully phased up to the Nasdaq National Market in December 2005;

--Completed $12 million private placement in November 2005 with a follow-on investment of $3.5 million received by the Company in February 2006 pursuant to the exercise of certain of the warrants issued in the private placement.

Key Goals and Milestones

--Continue to integrate and expand the molecular and pharmacogenomics services business to provide broader product and service offerings;

--Continue to build and expand the Vital Diagnostics business product line for physician practices and clinics;

--Build a leadership position in molecular testing using pharmacogenomics in the clinical care setting. The Company expects to introduce Therapeutic Diagnostics and to have it emerge as a leader in this market through leveraging of the Company's intellectual property, existing test franchises in cardiovascular and CNS, and expertise in the areas of pharmacogenomics and marker discovery;

--Begin to work with key constituents in the clinical and healthcare services markets to expand awareness of the Company's Therapeutic Diagnostics and related offerings;

--Introduce new Therapeutic Diagnostics into the clinical setting (where clinicians incorporate these products as tools to help guide treatment/drug decisions in order to improve patient outcomes).

--Capitalize on operational and other synergies from recent acquisitions;

--Achieve further growth in Europe;

--Complete enrollment of pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  for Vilazodone;

--Report initial Phase III Vilazodone study by mid-2007;

--File NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  for Vilazodone with FDA by as early as year-end 2008;

Clinical Data's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Israel M. Stein, M.D., said, "Clinical Data has made significant progress in calendar 2005 including our bold strategic repositioning of the Company to take advantage of anticipated growth trends in targeted diagnostics and personalized medicine The external links in this article or section may require cleanup to comply with Wikipedia's content policies. . We achieved key objectives in our Vital Diagnostics business and the companies we recently acquired each accomplished key objectives in their own right. We have summarized the collective major achievements of the Company's businesses and updated our goals to aid investors and clients in better understanding the focus and expertise of our business going forward."

Dr. Stein continued, "As we continue to integrate our molecular services assets and benefit from positive trends in our traditional diagnostics business, we look forward to accelerating our growth by capitalizing on the significant opportunities offered in our pharmacogenomics and diagnostics businesses."

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in providing molecular services and clinical diagnostics to improve patient care. Clinical Data's molecular services division is among the largest independent providers of pharmacogenomics and metabolomics services globally and consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005. The division is utilizing pharmacogenomics to develop molecular diagnostics and more efficacious therapeutics by finding genetic markers to guide drug development and utilization. These services are marketed to the pharmaceutical, biotech, clinical, academic, government and agricultural marketplaces. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l., which are each focused on the small volume clinical diagnostics market worldwide. Vital Diagnostics' instrumentation business has a market focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has also achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States.

Therapeutic Diagnostics and CARING are trademarks, and FAMILION is a registered trademark of Clinical Data, Inc. ALL RIGHTS RESERVED.

SAFE HARBOR Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 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 and statements 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. Such statements are subject to certain risks and uncertainties, the effects 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. These risks and uncertainties include, but are not limited to, whether vilazodone will advance further in the clinical trials process; whether future clinical trials will warrant continued product development; whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; whether vilazodone will be successfully marketed; whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Clinical Data does 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 also urged to carefully review and consider the various disclosures in Clinical Data's SEC reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q.

Internet Website: www.clda.com
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
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Geographic Code:1USA
Date:Feb 21, 2006
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