AssureRx last week launched its first commercial product, GeneSightRx, a genetic test to help physicians determine which psychiatric medications to administer to their patients.
The company describes GeneSightRx as a "multivariate, algorithmic, interpretive" test that will help guide treatment decisions. The genetic analysis for GeneSightRx is conducted through the Luminex 200 platform using the xTag process.
According to AssureRx, GeneSightRx is a laboratory-developed test. The company operates a CLIA-approved lab in Mason, Ohio.
The US Food and Drug Administration practices enforcement discretion for the majority of laboratory-developed tests. However, the agency has said it intends to regulate more complex, in vitro diagnostics multivariate index assays.
“We do not believe that GeneSightRx falls under the FDA guidance for IVDMIA,” a spokesperson for AssureRx told Pharmacogenomics Reporter this week. “As the guidance states that while the input variables of an IVDMIA, alone or in combination, might have meaning to the clinician, the clinician cannot verify the clinical significance of the IVDMIA result on his or her own, nor can he or she independently interpret the result.
“All the information on which our report is based is publicly available, and the report contains citations to all information,” the company spokesperson said. “Physicians can verify the information in the report and independently interpret the information supporting the report.”
The results of GeneSightRx are available through a web-based report to doctors. The test is only available through a doctor’s prescription. The test results are available within 48 hours.
Furthermore, AssureRx highlights that it does not make any efficacy claims for any of the medications on the test panel and the test report does not make any dosage recommendations outside of FDA-approved dosages.
The gene panel analyzes SNPs for CYP 2D6, CYP 2C19, 5HTTLPR (SLC6A4), and 5HTR2A. “We will be adding new SNPs every quarter and new alleles every six months,” a company spokesperson said.
According to AssureRx, although 200 million scripts for antidepressants are filled each year in the US, the failure rate for such drugs is as high as 50 percent. Previous to this broad commercial launch, AssureRx had made the test available to the Mayo Clinic and Cincinnati Children’s Hospital Medical Center on a limited basis.