How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c86274) has announced the addition of new Decision Resources report: How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers to their offering.

Introduction

Validating a biomarker is a resource-intensive undertaking. Is it worth it? We say, Yes. A biomarker that wins "known validated" status is best positioned for rewards: regulatory approval, optimal reimbursement, incorporation into personalized medicine The external links in this article or section may require cleanup to comply with Wikipedia's content policies. approaches alongside companion therapeutics, partnership and promotion opportunities, and wider awareness and uptake. Companies that recently began fielding biomarker-based tests are reporting success in terms of a revenue upswing. And they have laid the groundwork for validation of tomorrow's biomarker-based tools.

Get the Answers You Need to Shape Your Strategy

In December 2007, Panacea's LC Detect for early lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. diagnosis was named one of Time Magazine's Top 10 Medical Breakthroughs of 2007. What other biomarker-based tests are changing medical practice, and how?
- Validation is a key step in maximizing the clinical and commercial success of a biomarker. What is the validation process? What companies have successfully navigated it? What resources exist to facilitate the process?

- Validated biomarkers are the basis for several marketed companion diagnostics. Which products have received approval? How are these products faring? What tests are in development?

- For companies developing biomarker-based tests, a key strategy that taps the personalized medicine paradigm is to partner with drug developers. Which biomarker companies lead the pack? Which pharmaceutical companies have become involved in personalized medicine and drug/diagnostic co-development?

Scope

- About validated biomarkers: definitions, classifications, the value and process of validation.

- Types of biomarker-based tests: home-brew, de novo [Latin, Anew.] A second time; afresh. A trial or a hearing that is ordered by an appellate court that has reviewed the record of a hearing in a lower court and sent the matter back to the original court for a new trial, as if it had not been previously heard nor decided. , in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.
in vi·tro
adj.
In an artificial environment outside a living organism. diagnostic multivariate assay, therapeutic area focus (oncology is a leading area), technology focus (nucleic-acid testing, or NAT (Network Address Translation) An IETF standard that allows an organization to present itself to the Internet with far fewer IP addresses than there are nodes on its internal network. , is emerging as the key approach). Tables detail FDA-approved validated biomarkers and those in trials to achieve validation.

- Case studies: Genomic Health's Oncotype DX Oncotype DX™, created by Genomic Health, is a diagnostic test that quantifies the likelihood of disease recurrence in women with early-stage breast cancer and assesses the likely benefit from certain types of chemotherapy. and Agendia's Mammaprint.

- Biomarker development environment: recent approvals, reimbursement challenges, supporting consortia.

- Where is the pay-off?: company profiles, revenue trends, industry outlook.

Companies Mentioned:

- Affymetrix

- Agendia

- Biosite

- Cepheid

- Chugai

- Dako

- Eli Lilly Eli Lilly can refer to:

* Eli Lilly and Company, a global pharmaceutical company
* Colonel Eli Lilly (1839-1898), founder of Eli Lilly and Company
* Eli Lilly (industrialist) (1885-1977), former president of Eli Lilly and Company
*



- Exagen Diagnostics

- Fujirebio Diagnostics

- Genentech

- Genomic Health

- Genzyme Genetics

- GlaxoSmithKline

- Immunicon

- Kudos Pharmaceuticals

- LabCorp

- Merck

- Myriad Genetics Myriad Genetics is a leading biopharmaceutical company focused on understanding the relationship between genes, proteins and human diseases in order to develop the next generation of therapeutic and molecular diagnostic products.

- Nanosphere

- Novartis

- Panacea Pharmaceuticals

- Pfizer

- Prometheus Therapeutics & Diagnostics

- OSI Pharmaceuticals

- Roche

- Roche Diagnostics

- Siemens Medical Solutions Siemens Medical Solutions (Siemens Med) is a supplier to the healthcare industry, and is headquartered in Erlangen, Germany. Its U.S. division, Siemens Medical Solutions USA, Inc., is a Delaware corporation, with headquarters in Malvern, Pennsylvania.

- Third Wave Technologies

- Vanda Pharmaceuticals

- Ventana Medical Systems

- Veridex

- VTT VTT Technical Research Centre of Finland
VTT Valtion Teknillinen Tutkimuskeskus (Finnish: Technical Research Centre of Finland)
VTT Vélo Tout Terrain (French: mountain bike; aka ATB or MTB)

- Vysis

- Wyeth

For more information visit http://www.researchandmarkets.com/reports/c86274.