Can PGXL Informatics Make Drugs Safer and More Effective?
PerMIT:Warfarin Authorized for Clinical Trial, Software Uses Genetics to Guide Patient Treatment
LOUISVILLE, Ky.--(BUSINESS WIRE)--PGXL Laboratories has received regulatory authorization to conduct clinical trials of its PerMIT:Warfarin companion informatics software. This favorable administrative decision allows PGXL to enroll up to 720 subjects in the trials, which will determine the safety and effectiveness of the software.
“This larger study goes a step farther”
PerMIT:Warfarin is a decision support tool driven by a set of algorithms. The software provides a graphic display of historical and projected aspects of treatment, allowing a more proactive approach to managing care. It analyzes genetic and other patient data to provide information physicians can immediately apply in the dosing and monitoring of warfarin, a commonly prescribed anticoagulant.
In normal practice, warfarin patients require numerous office visits and blood tests to detect and prevent adverse drug reactions (ADRs), which can include internal bleeding, thrombosis and death. To prevent those ADRs, the dosage is adjusted and blood tests taken in a gradual, iterative process that can take months to reach stable therapy.
A previous pilot study conducted by PGXL and published in Thrombosis and Haemostasis showed that patients treated using PerMIT:Warfarin reached therapeutic stability in a shorter time than those treated conventionally.
“This larger study goes a step farther,” says Dr. Mark Linder, Senior Executive Vice President of PGXL and co-inventor of PerMIT. “We’re going to test PerMIT’s effect on real-world outcomes. The study will determine if PerMIT reduces the frequency of times when the patient is at risk of either bleeding or thromboembolism. The trial is also designed to determine whether major and minor bleeding incidents will be reduced. We’re confident in a favorable result.”
PerMIT:Warfarin calculates an optimal therapeutic path based on variations in two genes, CYP2C9 and VKORC1, which control the metabolism and action of the drug. The software may enable physicians to avoid the pitfalls of standardized dosing regimens and calculate tailored dosing strategies to minimize variability and time to reach stable therapy.
PGXL is recruiting sites for the new study. Investigators are welcome to contact the company if they are interested in access to the software or participating in the trials. Previous studies were conducted at the University of Utah.
ABOUT PGXL LABORATORIES
PGXL Laboratories was the first lab in the country CLIA-certified specifically to conduct pharmacogenetic tests for Personalized Medicine. It provides genetic testing and interpretation for a broad range of medical conditions, and has developed proprietary genetic test panels for cardiology, pain management and psychiatry. In 2014, it opened an anatomic pathology lab with an emphasis on the diagnosis and treatment of cancer. Together, the molecular and AP labs provide unique, in-depth diagnostic capabilities without the difficulty of gathering and submitting multiple tissue and cell samples.
Along with its clinical practice, PGXL performs contract research for developers of pharmaceuticals and medical devices.