SureGene LLC and the Medco Research Institute™ LLC announced that they have entered into a novel investigative research collaboration to evaluate whether variation in genetic biomarkers previously identified by SureGene can help predict drug response for widely prescribed antipsychotic drugs in patients with serious mental illness.

The results of this research could help provide evidence supporting the development of genetic tests that would assist doctors to make more precise prescribing decisions, leading to improvements in outcomes, compliance and safety for these mental health patients.

Choosing the correct antipsychotic medication for patients suffering from severe psychiatric illness is a major challenge. When patients are not prescribed an effective antipsychotic drug, they are at an elevated risk of experiencing a serious adverse drug event. Current studies have suggested that less than one in three patients suffering from schizophrenia and related disorders will have an improvement in symptoms on the first antipsychotic drug prescribed. Poor response to treatment and the side effects of antipsychotic drugs can also result in low compliance, with 50 percent of patients discontinuing drug use within six months of starting a prescription. High discontinuation and poor compliance often results in hospitalization. While there are no currently marketed ways to identify which antipsychotic drug is optimal for a given patient, SureGene’s genetic test has demonstrated the ability to stratify drug efficacy of atypical antipsychotics, such as olanzapine and risperidone.

Through their collaboration, the companies will conduct the REST study – Relative Effectiveness of Schizophrenia Therapy – a prospectively designed clinical trial to further validate SureGene developed genetic biomarkers as predictors of efficacy and safety for commonly used atypical antipsychotics in the treatment of serious mental illness. In addition, the collaboration will evaluate the cost effectiveness of using SureGene biomarkers as a standard part of future clinical care for mental illness. Key to these objectives, Medco expects to collect 2,000 DNA samples obtained from plan members who agree to participate in the REST study.

"The REST study provides us an exciting opportunity to validate our technology in a real world setting. It has the potential to move us closer to making a real difference in the lives of people suffering from serious psychiatric illnesses using genetic information to guide drug selection," said Dr. Mark Brennan, SureGene’s Chief Scientific Officer.

Personalized medicine is an area of healthcare that is becoming more widely used to focus on how a person’s genetic makeup can affect their ability to respond to medications, allowing physicians to make more effective and safe selection or dosing of a drug with the benefit of this additional genetic information.

"A study of this nature has the potential to show that understanding a patient’s genetic risk with the help of a diagnostic test can improve antipsychotic drug selection, efficacy, safety and compliance," said Medco Vice President of Personalized Medicine Research and Development, Dr. Felix Frueh. "Medco’s research partnership with SureGene could help provide evidence supporting the development of a genetic test that may assist physicians to make a personalized treatment decision for patients with these serious diseases."

This study with SureGene is Medco’s first personalized medicine research effort in the area of mental illness. Medco has also conducted extensive personalized medicine research regarding genetic factors affecting patient responses to medications used for the treatment of cardiovascular disease, such as warfarin (Coumadin®) and clopidogrel (Plavix®).

As a scientifically-driven healthcare company, Medco recently underlined its commitment to research by announcing plans to acquire United BioSource Corporation (UBC). UBC is one of the world’s most respected sources of post-approval drug and device research focused on accelerating the generation of critical pharmaceutical knowledge to advance patient safety and to further evidence-based medicine. The acquisition is subject to regulatory reviews and approvals, and is expected to close in the third-quarter of 2010.

Source: Medco Research Institute