Clinical Data (Newton, Massachusetts), which focus-es on providing molecular and pharmacogenomics services as well as clinical diagnostics, reported further refinement of its organizational structure following acquisitions in 2005.

The company's business units now include three divisions: PGxHealth, Cogenics and Vital Diagnostics.

Clinical Data said it “continues to integrate its molecular and pharmacogenomics services, reflecting its completion and integration of a series of strategic acquisitions in 2005.“

In an effort to combine diagnostics with pharmacogenomics, Clinical Data said in June it was taking over Genaissance Pharmaceuticals (New Haven, Connecticut) in an all-stock deal valued at about $56 million (Medical Device Daily, June 23, 2005).

In December, Clinical Data closed its acquisition of Icoria (Research Triangle Park, North Carolina) following approval by Icoria stockholders (MDD, Dec. 22, 2005).

Israel Stein, president and CEO of Clinical Data, said at the time that “Icoria's metabolomics and gene expression capabilities will significantly enhance the pharmacogenomics technologies we acquired through our merger with Genaissance Pharmaceuticals.“

Drew Fromkin, executive vice president of Clinical Data and president of PGxHealth, told Medical Device Daily, that the reorganization was necessary to “make sure that the market and certainly our clientele had a sense of where these different kinds of services fit in, so they would be better bucketed. And to start to give the market a much better sense of how these different services met the needs of varying constituents.

The company said that the PGxHealth and Cogenics divisions “collectively position Clinical Data among the largest independent providers of pharmacogenomics and clinical diagnostics services in the world.“

Clinical Data said it is “dedicated to using a variety of scientific methods (e.g. genotyping, sequencing, gene expression, bioinformatics and metabolomics) to improve drug development, enhance patient outcomes and reduce the total cost of care.“

Fromkin also said that “some of the intellectual property and capabilities that came from the Genaissance acquisition is going to be focused more through our PGxHealth division, which is a growing molecular and pharmacogenomic diagnostics group.“

He said the constituents in the PGxHealth group “tend to be more on the payor-provider-consumer side.“

The company's new tagline is: “From Targeted Science to Better Healthcare.“

In a statement, Fromkin said, “Cogenics is a strong, established business propelled by a comprehensive set of molecular and pharmacogenomics services, all of which are essential to aiding and improving drug development and related activities. PGxHealth is a new, growing and distinct business that employs advanced, molecular services and targeted science to discover novel efficacy and safety biomarkers.“

A look at the new business units:

PGxHealth “builds upon existing assets acquired from Genaissance Pharmaceuticals in the areas of genomics-based, clinical diagnostics, therapeutic efficacy and safety biomarker development for drug utilization.“

The division has begun a pivotal Phase III clinical trial for Vilazodone, a compound being studied for treatment of depression, to be used in combination with a genomics based efficacy biomarker. T

The division also is responsible for the development of a safety biomarker for use with the anti-psychotic clozapine and of genetic markers for cardiac care.

PGxHealth is focused on discovering genetic markers that assist healthcare providers in determining the most efficacious and safe therapeutics for patients and, in some instances, an individual's propensity for a given disease. The company said it intends to develop and introduce therapeutic diagnostics in combination with new and existing therapeutics.

Clinical Data already is developing and delivering clinical diagnostics based on its own intellectual property, in-licensing additional intellectual property and partnering with pharmaceutical, biotechnology, and academic institutions, all with the goal of marketing new clinical diagnostics with an emphasis on targeted therapies.

Using its HAP Database as a resource for biomarker and single nucleotide polymorphism (SNP) identification along with other available resources, PGxHealth has “an advantage with respect to its own marker discovery efforts as well as for its initiatives with partners,“ the company said.

Today, PGxHealth has or is pursuing the development of tests in the central nervous system, cardiovascular and oncology fields.

Cogenics' business and lab operations are represented by the combined operations, sales and marketing infrastructure of Genaissance Pharmaceuticals, Lark Technologies and Icoria. The division provides a comprehensive range of in-house molecular and pharmacogenomics services to pharmaceutical, biotech, academia, agricultural, and government clients. These services are offered in both research and regulated environments. Furthermore, the services have applications across the lifecycle of pharmaceutical product development.

The division's service offerings include DNA and RNA extraction; genotyping on a variety of platforms; sequencing; gene expression and pathway analysis; tissue laser dissection; and biorepository. In addition, the Cogenics division utilizes know-how and products from PGxHealth in support of clinical trials including development of protocols and informed consents for genetic testing and genotype-phenotype association analysis for the discovery of biomarkers for Cogenics' clients.

Cogenics also assists its clients in the application of pharmacogenetics in evaluation of the proarrhythimic or QT-prolonging potential of molecules in development.

It currently runs and has in development numerous GLP-validated and research assays. These assays cover key SNPs relating to target identification, drug development activities and ultimately drug usage in specific populations and apply to both biologics and small molecules in all therapeutic areas. Along with its marketing focus, the Cogenics business unit has extensive experience working with platform providers including Affymetrix, Agilent, ABI and others for its sequencing, genotyping and gene expression services.

Clinical Data also has a group that will focus on metabolomic profiling that leverages its expertise and multi-platform technologies to address the growing need for mechanism-based biomarkers in drug development and medical care. This group has the capabilities to measure and interpret biochemical changes in cells, tissues and biofluids using mass spectrometry and advanced informatics.

Vital Diagnostics is derived from the operations of Clinical Data Sales & Service, Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab. This division is geared toward servicing the clinical laboratory in the traditional clinical in vitro diagnostics (IVD) market worldwide with a focus on the physician's office, hospital and small-to-medium sized laboratory segments.

“With customers in about 100 countries, Vital Diagnostics has also achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the U.S.,“ the company said.