Cowboy:
A refresher:
FDA Initiative and Pharmacogenomics
In a recent release, the FDA announced that pharmaceutical and bio pharmaceutical companies should take into consideration genetic testing during clinical trials and for post approval drug monitoring. Pharmaceutical and bio pharmaceutical companies will need to incorporate genetic testing in their drug discovery, clinical development as well as post drug approval monitoring in the very near future. Leveraging its proprietary ADMIXMAP, MALD/AIM, AIMs, and ultra high throughput SNP screening technologies, DNAPrintTM is strategically positioned to serve the growing compliance and operational needs of pharmaceutical companies.
The FDA estimates that 2.4 million patients had adverse drug reactions in 2000, leading to the deaths of more than 125,000 patients. Adverse drug reactions represent the fourth leading cause of death in the United States.
As part of the FDA’s mandate to reduce the number of deaths caused by adverse drug reactions, on January 31, 2003 the FDA released an initial statement covering new initiatives related to pharmacogenomics. The FDA recognizes that new therapies will be developed because pharmacogenomic tests that can define sub-populations that exhibit a differential response to drug therapies will be available. As a result, the FDA plans to hold a workshop in 2003 to discuss issues involved in the co-development of pharmacogenomics tests and drugs. By mid-2004, the agency plans to issue joint guidance between The Center for Devices and Radiological Health (“CDRH”) and The Center for Drug Evaluation and Research (“CDER”) outlining the regulatory pathway to approval for drug/pharmacogenomic diagnostic combinations. In 2005, the FDA plans to issue guidance on when and how to submit pharmacogenomic information to the agency during the drug development process and clarify when such information will be considered as part of the drug safety evaluation process.
Within the next 12 months we believe there will exist a clear path to market for pharmacogenomic tests linked to drugs. In addition, with greater FDA recognition of pharmacogenomics, the pharmaceutical industry will accelerate its rate of adoption for pharmacogenomics tests.
---------------------------------------------------------------Potential opportunity
Sociopolitical developments indicate a favorable market opportunity for DNAPrintTM’s forensic DNA products. On March 11, 2003 Attorney General John Ashcroft announced that the administration plans to commit $1 billion to DNA testing over the next five years. The money announced by Ashcroft will be used to develop better genetics testing techniques, eliminate DNA backlog of nearly 360,000 cases and provide funds for police departments to use DNA testing more frequently in their investigations, thereby reducing the likelihood of wrongful prosecution and imprisonment.
- Ann
AI
