Clinical Data Launches PGxHEALTH™ and Cogenics™
News Mar 02, 2006
Clinical Data, Inc. has announced further refinement of its organizational structure. The company's business units now include three divisions: PGxHEALTH™, Cogenics™ and Vital Diagnostics ™.
Clinical Data continues to integrate its molecular and pharmacogenomics services, reflecting its completion and integration of a series of strategic acquisitions in 2005.
The following business structure furthers Clinical Data's commitment to its clients as highlighted in the Company's new tag line, "From Targeted Science to Better Healthcare™."
- PGxHEALTH - Introducing Therapeutic Diagnostics™: 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 commenced a Phase III clinical trial for Vilazodone to be used in combination with a genomics based efficacy biomarker.
The division is also responsible for the development of a safety biomarker for use with the anti-psychotic clozapine and of genetic markers for cardiac channelopathies including Familial Long QT Syndrome (LQTS), Brugada Syndrome, Short QT Syndrome (STQS), and related syndromes.
PGxHEALTH utilizes its expertise and infrastructure to discover genetic markers that assist healthcare providers in determining the efficacious and safe therapeutics for patients and, in some instances, an individual's propensity for a given disease.
The company intends to develop and introduce Therapeutic Diagnostics™ in combination with new and existing therapeutics.
- Cogenics - Comprehensive Pharmacogenomics and Molecular Services™: Cogenics' business and lab operations are represented by the combined operations, sales and marketing infrastructure of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc.
The division is designed to provide 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, these services have applications across the lifecycle of pharmaceutical product development, including pharmacovigilance requirements post launch.
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, as recommended in the draft guideline ICHE14, currently in Step 5 of implementation.
Cogenics 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.
Clinical Data has a group that will focus on metabolomic profiling that is designed to leverage 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 - Making Diagnostics Accessible™: Vital Diagnostics is derived from the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l.
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.
Drew Fromkin, Executive Vice President said, "Our decision to restructure Clinical Data's molecular services operations and create new branding for the organization reflects management's desire to better define the Company's distinct capabilities."
"This approach further enables the Company to develop focused offerings that meet the unique requirements of our diverse clientele."
"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."
"Our Company incorporates these findings into its Therapeutic Diagnostics with the intention of using these tests to optimize drug utilization in specific populations and achieve improved clinical outcomes, which ultimately reduces the total cost of care."
"We are all very excited about Clinical Data's current set of assets as a strong foundation for these two divisions and the opportunity to provide our clients and the healthcare industry with these valuable, innovative solutions."
Unlike most cells in the rest of our body, the DNA (the genome) in each of our brain cells varies from cell to cell, caused by somatic changes. But much remains unknown, including when these changes arise, their size and locations, and whether they are random or regulated. Now, researchers have developed new techniques allowing the detection of CNVs smaller than one million base pairs.