|MDDScore - Depression Blood Test|
MDDScore is a multi-analyte simple blood test that describes a person’s likelihood of having Major Depressive Disorder (MDD). The test was developed, tested, and available through Ridge Diagnostics.
Ridge Diagnostics is a diagnostic company with a neuropsychiatric focus. Ridge seeks to apply unique, patented technology using blood-based tests for the diagnosis, treatment selection and monitoring of therapy used in psychiatric disorders.
MDDScore blood test began with a Human Biomarker Library of approximately 120 biomarkers and a goal to design an accurate diagnostic test to aid in the diagnosis of Major Depressive Disorder (MDD) that was a biologic representation of a patient’s state of mind. A review of current biomedical literature to identify candidate biomarkers that were representative of the key biological pathways known to be involved in MDD, helped to narrow the list of potentially useful biomarkers to approximately 50.
The blood of healthy “normal” people and the blood of people, who had been diagnosed with MDD, were then analyzed to measure the levels of the 50 markers. Looking for statistically significant differences between blood biomarker levels measured in the “normal” compared to the “MDD”, the list of 50 markers was narrowed to 9 which are representative of four biological pathways: HPA Axis, Inflammatory, Neurochemical, and Metabolic.
Based upon these findings, a mathematical algorithm was created that could accurately separate the “normal” and “MDD” blood samples, and provide a single composite result from the individual biomarker measurements. The proprietary algorithm helps to provide mathematical model stability which improves the accuracy of the test results. The single score is a result that is meaningful and can be easily used in psychiatry, primary care or a specialty setting.
MDDScore is a multi-analyte immunoassay panel, consisting of biological markers selected from Ridge’s Human Biomarker Library. Although each component marker does not have the ability to stand on its own to accurately diagnose Major Depressive Disorder (MDD), each was selected based upon its role in reflecting processes involved in the pathophysiology of depression.
MDDScore is a laboratory test that provides the clinician with a single test result which represents the patient’s likelihood of having MDD. The biomarker serum measurements and the unique algorithm result in the MDDScore value. MDDScore’s power resides in the combination of the individual biomarkers and a proprietary mathematical algorithm that provides an individual result or score that is highly indicative of MDD.
The test result is intended to be used as an aid in the diagnosis and management of MDD and is to be used in conjunction with other clinical and laboratory information.
MDDScore is intended to be used as an aid in the diagnosis of Major Depressive Disorder (MDD). It describes the likelihood a person has MDD. While it is not meant to replace traditional interview methods, studies have found it to correlate with commonly used assessment tools (ie HAM-D, Beck, PHQ-9).
The technology is new and different from the tools clinicians have traditionally used to diagnose MDD. Prescribing clinicians have found MDDScore useful in many clinically important scenarios such as:
How to Order
Complete the patient test requisition form and ask your patient to visit one of the Ridge Diagnostics contracted blood draw facilities. Request the patient visit the lab within two days so you will have the test results prior to their next visit.
Test Requisition Form
Laboratory draw sites across the country can collect specimens to be shipped for testing at Ridge's CLIA certified laboratory in North Carolina. Specimen transportation kits are offered at no charge to ship samples to our laboratory. Specimen transportation kits can be sent to you or your local laboratory. For additional information, please call 800-578-7818 ext. 103.
What the "Score" Means
MDDScore describes the likelihood that a person has MDD.
Most insurance companies reimburse for the test.
On behalf of the patient, Ridge Diagnostics will bill the patient’s medical insurance plan directly. We accept Medicare, Tri-Care, Workmen´s Compensation and independent third-party insurance. Ridge Diagnostics does not accept Medicaid or Medi-Cal. A number of factors affect the amount covered based on the specific insurance plan, co-pay, deductibles etc. If the claim is denied on first review, Ridge can assist in providing any additional information requested as well as help in appealing this denial. If all appeals are exhausted and the claim is not fully paid, the patient may be responsible for any balances remaining on the invoice. Please contact Ridge Diagnostics for payment options and discount programs at 800-578-7818 ext. 103.
Frequently Asked Questions
What are the biomarkers in MDDScore?
Biomarkers from four key biological pathways that have been implicated in depression comprise the MDDScore. See table below.
Why do I need a test for depression? I have been diagnosing depression throughout my career.
Consider MDDScore from the patient’s perspective. A blood test may provide your patient with biological evidence that can help him/her to accept and/or understand their diagnosis. It may also help their loved ones accept and support them throughout their therapy. In some cases, patients may have been resistant to the therapy interview or not completely forthcoming with critical information and the availability of a blood test may encourage cooperation. Finally, there are some patients who just do not seem to be getting better on their anti-depressants (estimates are 20%) and a blood test could help you and your patient explore other treatments and diagnoses.
How does MDDScore blood test compare to HAM-D, Beck and PHQ9?
MDDScore is an objective laboratory method to aid in the detection of MDD. HAM-D, Beck and PHQ9 are interview or subjective paper and pencil screening tools to aid in the detection of MDD which are meant to be strictly administered and scored according to their respective protocols. Because MDD affects people differently, no assessment method is intended to be used alone. In various studies, MDDScore has a sensitivity of 94% while the HAM-D, Beck and PHQ9, when administered according to their protocols, have reported sensitivities of 78%, 84% and 80%, respectively. MDDScore specificity of 92% is greater than that of reported study results on the HAM-D (75%) and Beck (82%). The PHQ9 has a range from 72% to 80.0%.
What is the validity and reliability of MDDScore blood test?
MDDScore is a robust tool to aid in the diagnosis of MDD. MDDScore clinical validity is measured in terms of “sensitivity” and “specificity” - when compared to a variety of established clinical interview tools.
Sensitivity describes the proportion of actual positives which are correctly identified as such (e.g. the percentage of people with MDD who are correctly identified as having the condition). MDDScore has been shown, through studies comparing people with MDD and normal individuals, that its sensitivity is approximately 94%.
Specificity describes the proportion of negatives which are correctly identified (e.g. the percentage of healthy people who are correctly identified as not having MDD). MDDScore has a specificity of 92%.
MDDScore measures blood-based biomarkers using well-established laboratory technology performed in a CLIA certified laboratory. Test reliability refers to the analytical robustness of a test. Each biomarker in the MDDScore panel has been rigorously tested for reproducibility (getting the same answer on standard test samples over and over) and other key analytical parameters. This testing is required before the test can be a CLIA lab service test.
Will MDDScore differentiate MDD from bipolar?
MDDScore describes the likelihood that a person has MDD.
Will the test be accurate if the patient is already on an anti-depressant?
Yes. If a patient is currently being successfully treated with an antidepressant, studies suggest it is likely they will continue to have a high MDDScore.
Is the MDD Score FDA Approved?
MDDScore has met all regulatory requirements to be offered as a laboratory service in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Is Ridge Diagnostics CLIA certified?
Ridge Diagnostics laboratory has been certified through CLIA (Clinical Laboratory Improvement Amendments) to offer MDDScore as a CLIA lab test. CLIA’s mandate is to ensure quality laboratory testing.
How long does it take to receive my patient’s MDDScore?
Ridge Diagnostics will send patient's results to the ordering physician within 7 to 10 business days of specimen receipt.