Ridge Diagnostics (La Jolla, Calif.) is preparing a national commercial launch for its MDDScore test for the diagnosis of major depressive disorder. The multianalyte proteomic assay gives patients and physicians an objective measure for diagnosis, and developers believe it can lead to more successful treatment. “The first thing is we need to get the right diagnosis,” says Lonna Williams, Ridge’s CEO. “Half of anti-depression prescriptions don’t work. Contributing to that is that a patient might have depressionlike symptoms, but they may not actually have depression.” The enzyme-linked immunosorbent assay is based on nine biomarkers associated with four biochemical pathways: inflammatory (alpha1 antitrypsin, apolipoprotein CIII, myeloperoxidase, soluble tumor necrosis factor alpha-receptor type II), the hypothalamic-pituitary-adrenal axis (epidermal growth factor and Cortisol), neurotrophic (brain-derived neurotrophic factor), and metabolic (prolactin and resistin). Concentrations of the biomarkers are entered into an algorithm to calculate the MDDScore, which is presented as a value one through nine with an increasing value equating to an increasing likelihood of major depressive disorder—a score of eight represents an 80 percent likelihood. “It helps for patients to see objective results,” Williams tells DTTR. “When they see it is a disease it is more likely the stigma goes away. Their family […]
Ridge Diagnostics (La Jolla, Calif.) is preparing a national commercial launch for its MDDScore test for the diagnosis of major depressive disorder. The multianalyte proteomic assay gives patients and physicians an objective measure for diagnosis, and developers believe it can lead to more successful treatment.
“The first thing is we need to get the right diagnosis,” says Lonna Williams, Ridge’s CEO. “Half of anti-depression prescriptions don’t work. Contributing to that is that a patient might have depressionlike symptoms, but they may not actually have depression.”
The enzyme-linked immunosorbent assay is based on nine biomarkers associated with four biochemical pathways: inflammatory (alpha1 antitrypsin, apolipoprotein CIII, myeloperoxidase, soluble tumor necrosis factor alpha-receptor type II), the hypothalamic-pituitary-adrenal axis (epidermal growth factor and Cortisol), neurotrophic (brain-derived neurotrophic factor), and metabolic (prolactin and resistin). Concentrations of the biomarkers are entered into an algorithm to calculate the MDDScore, which is presented as a value one through nine with an increasing value equating to an increasing likelihood of major depressive disorder—a score of eight represents an 80 percent likelihood.
“It helps for patients to see objective results,” Williams tells DTTR. “When they see it is a disease it is more likely the stigma goes away. Their family understands it is a physical thing and psychiatrists have told us the patient is then more compliant with their treatment plan. It is a big positive for both patients and physicians.”
The test is run out of Ridge Diagnostics’ CLIA-certified laboratory in Research Park Triangle, N.C. The blood-based test is currently turned around in five days and lists for $745. The company’s long-term reimbursement strategy is to contract directly with payers as the company believes there is an economic case for the test. Ridge Diagnostics has seen positive coverage decisions in its two pilot markets. A sales force has already begun selling directly to community-based psychiatrists in 15 major metropolitan areas.
In addition to the MDDScore, the company says its biomarker hypermapping affirms the heterogeneity of depressed populations and can aid in the subclassification of patients. Williams says the company is using this insight to pursue partnerships with pharmaceutical companies. The privately held company is also developing a separate test that will be used to monitor response to anti-depressants based upon changes in physiological markers. Preliminary data show that within one week response to treatment can be detected.
