Good overview of pharmacogenetics by Dr. Russ Altman at TEDxStanford, here. Based on Tylenol 3 and CYP2D6, Dr. Altman walks through the mechanics and potential significance of pharmacogenetics (which he calls “a terrible word.”)
The New England Journal of Medicine recently published an article, “A Randomized Trial of Genotype-Guided Dosing of Warfarin,” comparing the effect of genotype-guided dosing with that of standard dosing on anticoagulation control in patients starting warfarin therapy. A total of 455 patients was used in the trial where it was concluded that genotype-based dosing at the initiation of warfarin therapy increased the time in the therapeutic range and reduced the incidence of excessive anticoagulation, the time required to reach a therapeutic INR, the time required to reach a stable dose, and the number of adjustments in the dose of warfarin.
This also confirms an article by PGXL’s Dr. Mark Borgman, “Prospective Pilot Trial of PerMIT Versus Standard Anticoagulation Service Management of Patients Initiating Oral Anticoagulation,” The trial studies 26 subjects to compare genotype-based warfarin initiation and maintenance dosing with routine anticoagulation service management. The concluding data strengthened the case for prospective utilization of genotype information for warfarin therapy management. With more trials and findings resulting in genotype-testing benefits, clinical outcomes and patient benefits should hopefully improve in the future.
A lot of attention has been paid to the business of genetics in the wake of the FDA’s decision to stop 23andMe from offering genetic tests for sale to the public. Without getting into the specifics of that case, we would like to remind everyone that PGXL provides its genetic testing services exclusively to physicians and qualified researchers.
The field of genetics is complicated and fast-changing. PGXL believes its responsibility is not just to deliver test results, but also the interpretation it takes for doctors and their patients to make intelligent, informed decisions. For that reason, we do not offer our tests to the general public.
If you believe you could benefit from PGXL’s testing, have your healthcare provider contact PGXL.
CVS Caremark’s new study, published in the November issue of the AHA’s journal Circulation: Cardiovascular Quality and Outcomes, examines genetic testing in cardiovascular treatment and what is being done with its patients. According to the study, a significant amount of patients were recognized as poor metabolizers of the blood thinner clopidogrel, however only a small amount of those patients took action from the results. This leaves a large, open opportunity to provide physicians with the knowledge needed to understand and correct their patient’s medications.
”While there is significant uncertainty about how clinician’s should respond to the results of genetic testing for anti platelet drugs, this study clearly shows that patients and their doctors need more guidance and education about how best to apply these results to improve patient incomes,” says Niteesh K. Choudhry, MD, PhD, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, associate professor, Harvard Medical School and the study’s senior investigator.
Genomind, a partner to PGXL Laboratories, has recently presented a poster of new data titled, “Pharmacogenetic Testing Prompts Increased Medication Adherence and Reduced Healthcare Resource Utilization in Psychiatric Patients.” The poster explains the Genecept Assay and the benefits to the patients. Also, the poster showed the cost savings that was observed over the four month trial period for patients who used the assay compared to patients who did not.
PGXL will continue to help personalized medicine companies such as Genomind develop these assays for their patients. For more information on PGXL Laboratories and assay development, please click here.
The FDA has published a long (60 page) paper outlining what it sees as its responsibilities in the advance of Personalized Medicine. “Paving the Way for Personalized Medicine: The FDA’s Role in a New Era of Medical Product Development” does a great job of defining the attributes of Personalized Medicine, as well as documenting its history and potential.
Along with everything else, the report stresses the importance of incorporating Personalized Medicine into pharmaceutical research, which PGXL does through its contract research group. According to the FDA, adding capabilities like PGXL’s to drug development can improve the results:
Personalized Medicine also promises to enhance medical development by improving the probability of success. For example, many drugs under development never reach the stage of being submitted to FDA in an application requesting approval for marketing. High attrition rates stem largely from failure of the drugs to meet expected efficacy levels, to demonstrate improved outcomes over a comparator drug, or to demonstrate sufficient safety to justify their use. Improving our understanding of the underlying causes of variability in patient response should catalyze an increase in the numbers of drugs that are shown to be safe and effective and make it to market.
You can download the whole report here.
Research has been published that begins to quantify the value of pharmacogenetic testing. Genomind analyzed data associated with its Genecept assay, determining that patients using the assay had significantly increased medication adherence rates resulting in a cost savings of 9.5% over the four month trial period. This equates to an annual cost savings of $1,827 per patient.
“This is the first study of the Assay assessing its impact on resource utilization and medication adherence.” said Dr. Jay Lombard, Chief Scientific Officer and Medical Director, Genomind. “This study provides real-world observational evidence that the Genecept Assay can lead to increased medication adherence and lower healthcare costs.”
The Genecept Assay is designed to inform response to different psychiatric treatments. It applies to a range of psychiatric conditions including depression, bipolar disorder, schizophrenia, anxiety disorders, OCD and ADHD.