In his APA presentation, Renshaw described a community-based study designed to validate the biomarker panel for MDD. Thirteen psychiatrists, 1 nurse practitioner, and 1 physician assistant participated in a Clinical Experience Program (CEP) in which they enrolled patients with previously diagnosed MDD or those in whom MDD was suspected.
A total of 95 patients with a range of psychiatric diagnoses—predominantly MDD—were enrolled, and 80 completed the study. In addition, 51 healthy individuals constituted a control group.
For the vast majority of patients, MDDScore results ranged from 6 to 9. Their test scores were highly predictive of the clinical diagnosis they had previously received.
The MDDScore was able to discriminate patients with a clinical diagnosis of MDD from the normal control group, according to Renshaw. The P value for segregating MDD patients from healthy controls was highly significant (P < .0001) over a broad range of male and female patients.
At the time of study entry, all MDD patients were receiving one medication or a combination of medications for their psychiatric disorders, such as escitalopram(Drug information on escitalopram) or duloxetine(Drug information on duloxetine). However, test results did not seem to be affected by the presence of antidepressants, Renshaw explained.
Renshaw told Psychiatric Times that beyond the CEP, he helped Ridge’s founders organize clinical trials of their new technology in Boston and in Seoul, South Korea.
According to Lonna Williams, Ridge Diagnostics’ Chief Executive Officer, the company has completed 5 clinical studies and has 2 ongoing prospective studies for the diagnosis of depression in adults.
“Additionally, we are currently enrolling teenagers in an NIH-funded study for adolescent depression. On conclusion of that study, we plan to make a test available to aid in the diagnosis of depression in adolescents,” she said.
The company also is planning a clinical study to further validate the MDDScore for use in the primary care population; has proposed studies with the US military; and has a biomarker panel for antidepressant treatment efficacy/monitoring being evaluated in 2 clinical studies.
“We do not have a launch date for the therapy-monitoring product at this time but expect it sometime in 2013,” Williams said. “In conjunction with a major academic center in the US, we will begin research on a blood test to aid in diagnosing bipolar disorder.”
The MDDScore test, Williams said, currently costs $745 and is covered by some insurance companies. Payment plans are available for patients without coverage.
In clinical studies and in response to test orders from psychiatrists, other mental health professionals, and physicians treating chronic pain, the company had generated nearly 1000 test results as of early July.