A Medical Device Daily

Medco Health Solutions (Franklin Lanes, New Jersey) and Laboratory Corporation of AmericaHoldings (LabCorp; Burlington, North Carolina) reported a research agreement to advance the field of pharmacogenomics, an emerging science integrating genetics and drug treatment leading the way toward personalized medicine.

The research effort, centered on tamoxifen, is the latest in a growing field of studies linking individual genetics to the safety and efficacy of specific prescription drugs. Genotyping for the study will be performed using the FDA-cleared Roche AmpliChip CYP450 test.

Tamoxifen, a drug that deprives certain tumors of estrogen needed for their growth, treats some forms of breast cancer and prevents the disease from occurring in some women at high risk for the condition. Approximately 10 percent of women using tamoxifen do not fully benefit from the drug because of variations in genes encoding drug metabolizing enzymes.

“This agreement is between two industry leaders that are at the forefront of the movement toward personalized medicine. Companion diagnostics can help physicians determine which drug will be most effective for particular patients. This will benefit patients and lower healthcare costs by improving outcomes, enhancing safety and reducing ineffective drug regimens,” said Myla Lai-Goldman, MD, executive VP, CSO and medical director for LabCorp.

Genetic testing can help clinicians identify risk factors for disease and predict how a person is likely to respond to a wide variety of drugs, including commonly used prescriptions such as pain relievers, anticoagulants, and cancer drugs. This information has a bearing on what drug is selected and may help optimize doses for particular drugs.

Research has demonstrated that patients respond to drugs about 50%-75% of the time. For many chemotherapy treatments, the response rate is as low as 25 percent. Genetic information can help determine the drugs that will be safest and most effective for particular patients. For example, the metabolism of specific drugs has significance in pharmaceutical safety and efficacy, and laboratory tests can identify genetic variations that affect the rate of drug metabolism. Depending on the drug, a patient may not get the full benefit of therapy if a drug is metabolized too quickly or could experience toxicity if it is metabolized too slowly.

LabCorp develops new diagnostic technologies and says it is the first in its industry to embrace genomic testing. Medco is a pharmacy benefit manager.

In other agreements:

• Fenwal (Round Lake, Illinois) reported a new partnership with Data Innovations to develop, distribute and license a data capture and reporting system for Fenwal’s automated blood component collection systems. This collaboration will allow blood centers to export data from Fenwal’s automated blood collection devices into the Instrument Manager system that will generate standard and customized reports analyzing critical donor and procedural information.

A data capture and reporting system will help blood centers drive operational efficiencies by eliminating the need to manually capture this information from Fenwal’s automated collection devices. It will also allow blood centers to more easily identify and track donor and procedure trends, further improving their collection management efforts. Fenwal will begin offering a data capture and reporting system with Data Innovations in 2008 for its Alyx, Amicus and Autophersis-C automated collection devices in the U.S., and will then expand this offering to Europe and other regions.

Fenwal is a healthcare company focused on the development of products for the transfusion medicine industry.

Data Innovations says it is the world’s largest clinical laboratory middleware company and offers comprehensive solutions encompassing pre-analytical, analytical, and post analytical process improvement.