Bloomberg reporter Ryan Flinn recently wrote an article on Brain Scans Seek Best Drug Match for Depression Patients. The article summarizes some of the technologies that are being used by clinicians to assist in diagnosis and treatment of depression, and focused on technologies provided by two companies. The first company profiled uses a technology that matches EEGs – brain waves – to a database of matched EEG/depression scores, and the second uses a 30-minute computerized cognitive test that evaluates attention, memory, planning, impulsivity and emotions to predict which medication would be appropriate.
Although some clinicians support these approaches, generalized tests such as these are attempts to use unrelated non-physiological parameters to estimate the exact biochemical mechanisms going on inside the human body that direct the effects of the drugs. Different people have very different reactions to different drugs, as the piece emphasized. However, the pharmacodynamics and pharmacokinetics of drug metabolism and effects are the result of exceedingly complex biochemical pathways; brain waves and computer tests are poor methods for understanding them.
AssureRx: MEASURING METABOLISM OF DRUGS
Biological biomarkers that measure the exact metabolism of the drugs are a much better target for understanding patient responses. AssureRx Health, briefly mentioned in the Bloomberg piece, takes advantage of this concept. It uses advanced genomics tools to evaluate potential patient responses to psychotropic therapies. Claremont Creek Ventures has made two investments in AssureRx Health, and continues to believe the company has incredible traction.
AssureRx has developed and is successfully marketing a genomic test that provides detailed genetic information to physicians, and guides them in the selection of the right drug at the right dose for individual patients presenting with any and all psychiatric disorders, not just depression. This startup company is one of the early participants in the genomic transformation that is sweeping through the traditional practice of medicine.
OPPORTUNITY FOR INDIVIDUALIZED DRUG SELECTION
There is a large unmet need for individualized drug selection in psychopharmacology. There are approximately 70-80 million adult, adolescent, and pediatric patients in the United States with neuropsychiatric disorders. Annual hospital admissions include nearly two million patients with a primary psychiatric diagnosis and over seven million with secondary psychiatric diagnoses. Over 250 million psychotropic medication prescriptions are filled each year, with a value of almost $50 billion.
Drug selection and dosing in the behavioral health arena is generally empirical – using trial and error. Clinicians prescribe drugs based on standards of care and their own experience; however, individual patients have highly variable responses to their medications. Doses are started at low levels initially to avoid adverse events and are increased slowly until a result is observed; if not effective, clinicians switch patients to an alternate drug and reinitiate a lengthy titration period. This “start low, go slow” process may continue through multiple drugs until the clinician finds a drug and dose that will work for the specific patient. The misapplication of drugs in an outpatient setting can lead to ineffective treatment, adverse events resulting in hospitalization, and patient non-compliance.
The AssureRx test provides the missing biological information in the drug selection process. It measures and analyzes multiple clinically-important genetic variants that affect the metabolism and mechanism of action of drugs used in psychiatric medicine. The test is based on patent-pending pharmacogenetics technology developed at the Mayo Clinic and Cincinnati Children's Hospital, a thorough analysis of the scientific literature, and proven pharmacology. This technology results in a clear understanding of the genetic factors that influence an individual's response to drug treatments. A customized report of a patient's unique genetic makeup assists physicians with developing a personalized treatment plan for each individual patient that comes to them for help.
The AssureRx test addresses both clinical utility and pharmacoeconomics. Clinical utility will be demonstrated by the primary response of the patient to drug treatment; The remission of symptoms will be achieved more promptly with use of the test than without. In addition to more rapid recovery, other potential benefits are expected to include: a) reduced side effect burden; b) reduced need and duration of hospitalization; c) improvement in the quality of life and economic contributions of patients; d) improvement in patient satisfaction with their clinical care; and e) improvement in physician satisfaction by having more rational, evidence-based prescription support.
In addition to improving patient care, genomics will influence drug development processes. Every FDA clinical trial includes some patients who are not helped by the drug being tested, and some small proportion who have adverse reactions. AssureRx, by revealing the genetic individuality of each patient, will allow drug developers to select patients best positioned to respond positively to the drug being tested.
AssureRx is the only company with a comprehensive multi-gene test incorporating a sophisticated multi-variate algorithm that translates individual patient genetic data into simple, easy-to-use guidance for physicians. The ability to translate patient-specific information on drug effectiveness into a physician and patient-friendly report is a critical factor in the adoption of the test. Thus, there is an open playing field for AssureRx to establish market leadership at this rapidly evolving intersection of informatics and pharmacogenetics.
AssureRx Health was founded in 2006 to commercialize patent-pending pharmacogenetics technology from the Mayo Clinic and Cincinnati Children's Hospital. The initial AssureRx test is targeted for use by psychiatrists, behavioral health clinics and hospitals. More information can be found at www.assurerxhealth.com.