Genomind, a personalized medicine company focused on the psychiatric market, plans to provide early-adopter physicians with access to its Genecept Mood Assay, which provides information on patient genotypes that the company said can be used to guide treatment.
The company said this week that it has tapped DNA Genotek to provide the sample collection kits for its test as it ramps up production.
Genomind said the Genecept Mood Assay can help doctors "be more selective regarding medication choice and lessen the experimentation and guesswork often associated with determining appropriate medication," though the company has not disclosed any specific therapies that are associated with the test.
Patient samples are sent for analysis to PGxL's CLIA-certified lab, which performs the Genecept Mood Assay as a laboratory-developed test.
Last year Genomind studied the use of the test in two pilot projects: one conducted at Metrocare Services, a community mental health system in Dallas, Texas; and another at Schlosspark-Klinik, a private healthcare clinic in Berlin. The Dallas site involved 100 patients diagnosed with treatment-resistant depression, while 20 patients with TRD were enrolled in the pilot project in Berlin.
In these efforts, participating physicians were able to use the genetic information from the Genecept Mood Assay to make treatment decisions or confirm a previous treatment decision they had made by trial and error. Patients involved in the pilot projects expressed positive feelings about taking the test, and neither site had problems getting patient consent to be genetically tested, according to the company.
The results of these pilot studies have not been published.
Genomind said the panel of genomic markers within the Genecept Mood Assay is proprietary and company officials would not reveal which gene mutations are included in the test. Nancy Grden, Genomind's general manager, noted that the panel contains a mix of pharmacokinetic and pharmacodynamic genes.
Genomind is looking to conduct additional pilot projects to gain more information about the test. "We're just getting started," Grden said. "Over the next several months we are going to roll out more specificity around what we're doing."
The company is also not disclosing the types of treatments that the Genecept Mood Assay will inform. "It's not like there is one class of drugs to which patients are extremely resistant. I wish it were so," Grden said. In treatment-resistant depression patients, "the doctors don't know whether to switch classes, whether to keep the same class of drugs but change the dose, keep the same class [but] add another drug, or use an off-label."
Due to the lack of clarity about which treatment path is better, Genomid is hoping its test will be able to provide doctors more guidance in this regard. According to Grden, Genomind is currently trying to iron out an appropriate price for the test and is discussing with insurers possible reimbursement strategies for the Genecept Mood Assay.
Although there are several companies that have expressed an interest in exploring pharmacogenomic opportunities in the psychiatric space, there are few successful examples.
Last year, Clinical Data exited its genetic testing and biomarker development business. The move away from personalized medicine may have been triggered by the company's failure to advance its lead drug vilazodone as a genetically differentiated personalized medicine product in depression (PGx Reporter 11/17/2010).
Two years ago, Roche and Rules-Based Medicine subsidiary Psynova Neurotech inked an exclusive research and licensing agreement for the development and commercialization of a diagnostic immunoassay for "differentiating" schizophrenia treatments (PGx Reporter 12/09/2009).