Clinical Data Launches PGxHEALTH And COGENICS
PGxHEALTH Engaged in Discovery of Biomarkers and Introducing Therapeutic Diagnostics
COGENICS Provides a Broad Range of Pharmacogenomics and Molecular Services
VITAL DIAGNOSTICS Continues Focus and Performance in Traditional Diagnostics Market
Newton, MA - Clinical Data, Inc., a company providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care, 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 PGxHEALTH and COGENICS divisions collectively position Clinical Data among the largest, independent providers of pharmacogenomics and clinical diagnostics services in the world.
The Company 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. 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 pivotal Phase III clinical trial for Vilazodone, a novel compound being studied for treatment of depression, 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 most 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 novel Therapeutic Diagnostics in combination with new and existing therapeutics. Therapeutic Diagnostics are clinical diagnostics that utilize unique genetic markers or sets of genetic markers to determine which individuals will experience optimal benefit from specific therapies. Optimization of therapy for individuals will, in turn, result in the most desirable clinical outcomes for patients and their caregivers while also leading to reductions in the total cost of care for those who are paying for the care including but not limited to payors, employers and consumers.
Clinical Data is already 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. Utilizing its HAP(TM) Database as a resource for biomarker and 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.
Today, PGxHEALTH has or is pursuing the development of tests in the CNS, cardiovascular, and oncology fields.
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 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, 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. (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
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. Along with its marketing focus, the COGENICS business unit has extensive experience working with the market leading platform providers including Affymetrix, Agilent, ABI and others for its sequencing, genotyping and gene expression services.
Additionally, Clinical Data 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 - 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. 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.
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."
SOURCE: Clinical Data, Inc.